Human Subjects Research (HSR) Basic

Complete all 16 required modules.

Modules Co

Belmont Report and Its Principles (ID 1127) Inc

Students in Research (ID 1321) Inc

History and Ethical Principles - SBE (ID 490) Inc

Defining Research with Human Subjects - SBE (ID 491) Inc

The Federal Regulations - SBE (ID 502) Inc

Assessing Risk - SBE (ID 503) Inc

Modules Co

Informed Consent - SBE (ID 504) Inc

Privacy and Confidentiality - SBE (ID 505) Inc

Research with Prisoners - SBE (ID 506) Inc

Research with Children - SBE (ID 507) Inc

Research in Public Elementary and Secondary Schools - SBE (ID 508) Inc

International Research - SBE (ID 509) Inc

Modules Co

Internet-Based Research - SBE (ID 510) Inc

Conflicts of Interest in Human Subjects Research (ID 17464) Inc

Unanticipated Problems and Reporting Requirements in Social and Behavioral

Inc
Research (ID 14928)

University of Delaware (ID 12245) Inc

Supplemental Modules 

Modules Co

The IRB Administrator's Responsibilities (ID 13813) Inc

Modules Co

Avoiding Group Harms - U.S. Research Perspectives (ID 14080) Inc

Avoiding Group Harms - International Research Perspectives (ID 14081) Inc

Stem Cell Research Oversight (Part II) (ID 14584) Inc

Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or

Inc
Others in Biomedical Research (ID 14777)

Cultural Competence in Research (ID 15166) Inc

Humanitarian Use Devices (HUDs) (ID 16306) Inc

Modules Co

Populations in Research Requiring Additional Considerations and/or Protections (ID

Inc
16680)

Basic Institutional Review Board (IRB) Regulations and Review Process (ID 2) Inc

Informed Consent (ID 3) Inc

History and Ethics of Human Subjects Research (ID 498) Inc

Research Involving Prisoners (ID 8) Inc

Research Involving Children (ID 9) Inc

Modules Co

Research Involving Pregnant Women, Fetuses, and Neonates (ID 10) Inc

The IRB Member Module - 'What Every New IRB Member Needs to Know' (ID 816) Inc

Social and Behavioral Research (SBR) for Biomedical Researchers (ID 4) Inc

Records-Based Research (ID 5) Inc

Genetic Research in Human Populations (ID 6) Inc

International Studies (ID 971) Inc

Modules Co

FDA-Regulated Research (ID 12) Inc

Research and HIPAA Privacy Protections (ID 14) Inc

Vulnerable Subjects - Research Involving Workers/Employees (ID 483) Inc

Hot Topics (ID 487) Inc

I Have Agreed to be an IRB Community Member. Now What? (ID 13018) Inc

Stem Cell Research Oversight (Part I) (ID 13882) Inc

CE Credits Eligibility and Purchase

1.The Belmont Report and its Principles

2.Students in Research

Introduction

As an undergraduate, graduate, or doctoral

student, you may have the opportunity to
conduct or assist in research projects
involving human subjects (also called
participants). Such projects help you gain
experience with research methodology in
your field and understand and apply
ethical principles and guidelines for human
subjects research, as established by federal
regulations, professional associations, and
individual institutions.

This module is designed to address

students as researchers and when
students are involved in research as participants. It will review the history
and status of key research regulations, the Institutional Review Board (IRB)
review process, and general best practices when conducting human
subjects research.

Institutions often vary in how they apply certain regulations and how their
IRB process works. Before preparing an IRB submission or agreeing to
serve as a research assistant, you should talk with your faculty advisor
and/or your institutional IRB staff to understand local policies and
procedures.

Learning Objectives

By the end of this module, you should be able to:

 Discuss the historical development of regulations associated with

protecting human research subjects.
  Identify considerations in defining what constitutes “human subjects
research.”
 Describe standard categories of review regarding risks to subjects.
 Review general IRB submission procedures for projects involving
human research subjects.
 Discuss strategies for best practices in creating an accurate, robust
submission and conducting responsible, ethical research.

History of Ethical Regulations

While several different professional codes of ethics and regulations relate

to human subjects research and the protection of human subjects, four
primary ones include:

The Nuremberg Code

The Nuremberg Code resulted from the 1940s Nuremberg Military
Tribunal, during which Nazi physicians were convicted of unlawful
experimentation on concentration camp prisoners (Trials 1949a; Trials
1949b). The Nuremberg Code comprises ten principles regarding the
treatment of human participants in research. It establishes the
requirement of informed consent and voluntary participation (that is,
participants fully understand what the research involves and freely agree
to take part). It further states that benefits (whether to society or an
individual) must outweigh any potential risks, and that subjects must be
able to withdraw at any time without negative consequences.

The Declaration of Helsinki

The Declaration of Helsinki (developed by the World Medical Association in
1964 and last revised in 2013) sets forth morally binding ethical principles
for medical doctors engaged in biomedical research involving human
subjects, as well as identifiable human biospecimens and data. This
declaration, in combination with local and national regulations, helps to
establish an international standard of expectations.

The Declaration of Helsinki stresses that only well-trained, qualified

individuals should engage in research with human participants, and that
physicians must safeguard the health and safety of patients, regardless of
broader potential medical benefits. As with the Nuremberg Code, the
Declaration of Helsinki emphasizes the importance of informed consent
and mitigating harms or risks. Moreover, it notes that some participants or
groups may have greater vulnerability and therefore need additional
protections. Additionally, the Declaration of Helsinki explicitly states that a
research ethics committee (for example, an IRB) must first review and
approve all study plans (also referred to as protocols) prior to recruitment
and initiation.

The Belmont Report
The Belmont Report (The National Commission 1979) underscores similar
ethical considerations for protecting human research subjects. Specifically,
the Belmont Report identifies three key ethical principles:
 Respect for Persons
Respect for persons rests on two ethical convictions:

In other words, you compromise individuals’ free will if you do not respect
their autonomy (ability to think and act independently). Yet not all
individuals may be capable of understanding and voluntarily consenting to
research procedures; in these cases (for example, research with young
children or people experiencing dementia or other cognitive
impairments), extra protections must be put into place, and some
potential participants may need to be excluded for their own safety.

Beneficence
Beneficence means making choices that go beyond basic duty and
prioritizing participants’ well-being throughout a research study. It
involves two general rules:
Sometimes research may benefit society at large even though it may not
benefit individual participants at the time (for example, discovering future
treatments for childhood diseases may justify involving children in
research). However, harms to an individual may never exceed benefits to
a larger population.

Justice
In general, justice means that equals should be treated equally.  In
research studies, it means no one should unfairly receive benefits or
experience burdens. Historically, some research studies unreasonably
excluded women, others inappropriately recruited marginalized persons
of color, and still others collected data from children confined in
institutions.

For certain investigations, researchers might legitimately establish

inclusion or exclusion criteria surrounding age, race/ethnicity, gender, or
economic status.

However, the critical factor regarding justice is that certain individuals (for
example those belonging to a marginalized or vulnerable group) may not
face greater risks in participation, while those in another group (for
example, those in positions of power or with greater wealth) receive
benefits from the research. An ethics committee or IRB should evaluate all
research studies to ensure the equitable treatment of participants,
especially regarding benefits and risks.

The Common Rule

In the United States, researchers often cite the Common Rule, which is the
informal name of the U.S. Department of Health and Human Services
(HHS) Policy for the Protection of Human Subjects (45 CFR 46, Subpart A)
codified in 1981 and revised in 2018.

The Common Rule also offers additional protections for vulnerable groups
such as:
Many federal agencies and departments have not adopted subparts B, C,
and D. Therefore, only Subpart A is known as the "Common Rule."

Although the rule formally applies only to federally funded research, many
academic institutions use the Common Rule as the basis for reviewing
studies with human research participants. The Common Rule, together
with the documents described above, provides extensive guidance for
conducting human subjects research. However, it stops short of issuing
rules that apply to every situation and context. As a result, institutions
develop additional local policies appropriate for their culture and nature
of research.

Learning from Research Abuses and Misconduct

Unfortunately, research abuses and misconduct are not limited to past
events (for example the Nazi war crimes and Tuskegee Syphilis Study).
Research abuses and misconduct continue due in part to lack of
appropriate training or knowledge and intentional disregard for
regulations and policies.

For example, in the late 1990s researchers at the University of

Pennsylvania Institute for Human Gene Therapy recruited individuals for a
clinical trial investigating potential treatment for a rare metabolic disorder
(OTCD). The study came to a halt when Jesse Gelsinger—believed to be an
otherwise healthy teenager—experienced a fatal reaction to the treatment
and died within days of receiving the shot. An investigation of the teen’s
death revealed multiple ethical lapses in the researchers’ practices. They
failed to notify the FDA or pause the study when patients experienced
serious side effects. In screening potential participants, they ignored that
Jesse’s pretrial tests showed poor liver function. The researchers also did
not tell Jesse about other patients’ side effects or the death of two
monkeys from the treatment. The Gelsinger family sued the Institute,
which was later suspended by the FDA and shut down by the university.

One of the most well-known cases in recent years is the 2014 Facebook
Emotional Contagion study. For approximately a week, some individuals’
Facebook news feeds were altered to show mostly positive content,
whereas others saw primarily negative content. Researchers then studied
the “emotional contagion” effect of whether individuals subsequently
posted positive or negative items themselves (Kramer et al. 2014). At the
time, the study was not considered human subjects research by the
reviewing IRB and data access was consistent with Facebook’s data use
policy, but it is highly controversial from a research ethics perspective.
Many questioned the ethics of conducting a “secret” study that impacted
individuals’ personal interactions with others, without their informed
consent and without appropriate IRB review.

In these cases, ensuring that a study meets ethical and legal standards
underscores the principles of respect for persons and voluntary
participation. Consulting with an IRB or ethical review board allows
researchers at all levels to confirm that they have taken the necessary
steps for establishing appropriate participant protections.

What is human subjects research?

The answer to this question may seem simple, but even experienced
regulatory professionals often discuss what constitutes human subjects
research. Moreover, different institutions may interpret the regulatory
definitions in slightly different ways.

Therefore, two questions to consider when you begin thinking about a

project are:
Note: This section is based on the Common Rule. State and/or local law
(as well as the laws of other countries) may vary.

Does it involve "human subjects?"

According to the Common Rule, human
subject refers to “a living individual about
whom an investigator (whether
professional or student) conducting
research: (i) Obtains information or biospecimens through intervention or
interaction with the individual, and uses, studies, or analyzes the
information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or
generates identifiable private information or identifiable biospecimens.”

Let us take a moment to unpack the language in this definition. Note: We

have italicized some terms for emphasis.

 Living individual – Data must originate from live people; specimens

or information from dead people or cadavers do not count.
 About whom – Data are about living individuals (for example, their
beliefs, habits, practices, or blood or saliva specimens). You are
gathering information about someone not something.
 Intervention – The study involves some procedure or action that
affects the individuals or their environment to measure “before and
after” results.
 Interaction – Communication occurs directly with the participant
(for example, in person or by phone, email, videoconference, or
online survey)
 Identifiable private information – You or another member of the
research team can easily determine the participant’s identity. Private
means that the individual does not reasonably expect observation
 (in contrast to a public space such as a restaurant or bus), has
shared the information for study purposes, and can assume
identifiers will not be published without explicit permission (you will
learn more about the term “identifiable” in a later section).
 Biospecimens – Data taken from a living body such as saliva, urine,
blood, tissues, or cells.

Is it "research?"
The Common Rule defines research as “a
systematic investigation, including research
development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge.”
Additionally, the Belmont Report defines research as “an activity designed
to test a hypothesis [and] permit conclusions to be drawn” through a
formal study plan with a set of procedures to reach an objective.

Activities that federal regulations identify as “not research” include oral

history, journalism, biography, literary criticism, legal research and
historical scholarship that focuses on specific individuals about whom the
information is collected, as well as certain public health surveillance
activities under the direction of a public health authority.

However, institutions differ in how they apply these regulatory definitions.

For example, although the federal regulations include oral history and
student course projects in the “not research” list, some institutions review
these activities to ensure the protection of the human subjects providing
personal data.

Consider these different scenarios and how they relate to researcher’s

intent of “generalizable knowledge.”
Clearly distinguishing between studies designed to generalize to a larger
audience versus those that intend only to assess operational activities can
be challenging. Studies that appear focused on one goal may shift during
the project or serve multiple purposes (many studies intended only to
improve services, programs, or internal functioning are “quality
improvement” or “quality assessment” and do not need IRB approval).

Always check with your IRB early in the process to find out what activities
require review and approval. This will help ensure that you correctly follow
guidelines and remain in compliance with applicable regulations and
policies.

What is an Institutional Review Board?

Whether serving as the primary researcher

or a research assistant, you must follow all
institutional policies and procedures, best
ethical practices, and applicable federal
regulations. The IRB helps you meet those
standards by providing expertise and
resources, in addition to review and
approval processes.
IRBs review and oversee human subjects research conducted by students,
faculty, and staff. In this role, the IRB functions as a type of advocate to
help protect the rights and welfare of human subjects by ensuring
equitable subject selection, appropriate informed consent, risk mitigation,
and respect for privacy and confidentiality. Depending on institutional
policies, the IRB also may consider concerns for the rights and safety of
researchers, although these types of considerations will most often be
suggestions, not revision requirements.

IRB members must have the necessary experience and expertise to

evaluate proposed research projects. The committee – which may include
faculty, staff, students, and local community members – must be diverse
in terms of race, gender, cultural backgrounds, and awareness of local
community concerns. The IRB must include (45 CFR 46):

At larger institutions, the IRB may be part of a comprehensive, integrated

system, such as the Human Research Protection Program (HRPP). The
HRPP may include an Office for the Protection of Research Subjects, Office
of Compliance, Office of Contracts and Grants, and other institutional
officials and committees (for example, a community outreach program,
biosafety, or radiation safety).
At smaller institutions, the IRB typically has a limited staff who handle all
concerns regarding human research protections and report directly to one
of the top academic officials.

Regardless of the structure and nature of the IRB or HRPP at your

institution, staff members can address questions or concerns about the
IRB review and submission process.

Types of IRB Review

Research projects that meet the regulatory definitions of “human subject”
and “research” must receive IRB review. IRBs typically process research
study plans under one of three review levels:

This section provides an overview to help you better understand the

levels, but in most cases, the IRB will make the final determination.

In all cases, you must obtain written IRB approval (or notification of
exemption) before initiating any aspect of a research study, including
recruitment. IRBs cannot provide retroactive (after the fact) approval for
any data previously collected for a study.

If you engage in human subjects research activities without IRB approval,

your graduation or completion of your degree program could be delayed.
You might be required to destroy the data or turn the data over to the IRB.
Severe cases of noncompliance (for example, failing to follow IRB or other
institutional research policies) may result in a formal report of research
misconduct.
 Review for Exemption
Studies that involve no more than minimal risk and fit into one or more of
the regulatory exempt categories are “exempt” from the Common Rule
provisions and do not need further or ongoing review, unless the nature
of the study changes so that it increases risk level. Review some
examples of exempt studies.

If your project seems to fit one of the regulatory exempt categories, the
IRB will then consider the following questions to assess the study’s
potential risk level:

If the answer to any of these questions is yes, the IRB will likely require an
expedited or convened committee review because the research may
involve more than minimal risk of harm to subjects. Consult with your IRB
to be sure.

The institution policies and procedures should identify who is able to

review and make exempt determinations. This task is generally done by an
IRB member or experienced staff person, and managed through the IRB
office. Federal guidance recommends that researchers do not make their
own exempt determinations (OHRP 2020).
 Expedited Review
Studies that require expedited review typically involve some degree of risk
(for example, an increased privacy, psychological, or physical risk) to
subjects, but still to a minimal degree. For expedited studies, a limited
group of IRB members (the chair, members, and/or regulatory staff) will
evaluate the study plan (instead of the convened committee). The federal
regulations identify nine expedited categories (OHRP 1998). Some
common characteristics of research reviewed using expedited review
procedures include:

Convened Review
When research activities pose significantly higher risks to subjects than
those that might occur in daily life, the project will need convened review
(also commonly referred to as “full committee” or “full board” review) and
must receive majority approval from members at the meeting. While
student projects rarely involve this higher risk level, collecting data from
certain populations or on certain topics might trigger convened review.
Examples include research involving:

IRB Process for Student Researchers

Some institutions allow students to serve
as lead researchers, while others require a
faculty or staff member to serve as the
primary or principal investigator, with the
student listed as a co-investigator,
secondary investigator, or research
assistant. Regardless of your role, you
should assume responsibility for the
process, pay close attention to detail, and
compile the most professional study plan
submission possible.
After you consult with the IRB and/or your faculty advisor to determine
the correct review level and submission form(s) for your project, you
should assemble the required documents for IRB review. At a minimum,
most IRBs expect the following documents as part of a complete study
plan.

 An application for IRB review that includes the plan for recruiting
subjects, conducting the study, managing the data, and managing
potential risks of harm to the subjects, and lists who will be involved.
Some organizations may have different applications depending on
whether the study might qualify for exemption.
 Recruitment materials such as flyers, email or telephone scripts, and
social media announcements.
 Informed consent form or verbal script if you will collect oral
consent.
 “Instruments” such as interview or focus group questions, surveys,
or other procedures. While some IRBs require the exact questions
you intend to ask, others may allow guiding questions or themes.
Such decisions often relate to the sensitivity level of the topic or the
research design.
 Human subjects training certification for all researchers.
Based on institutional or IRB policy, the IRB may also ask for other
documents as a part of the submission, including:

 Site permission or approval (or approval from another IRB if one

oversees the proposed research site)
 Approval from an oversight agency (for example, the U.S. Food and
Drug Administration [FDA] if the study involves an FDA-regulated
product or a state department of health if it is administratively
responsible for oversight of a data repository; or approval from
school boards or officials for permission to use school district data).
 Copyright or use permission (for example, if the study involves the
use of a copyrighted instrument)
Work closely with your faculty advisor to ensure the submission is
consistent and includes all required elements. Incomplete or inaccurate
submissions will delay the review process. If your institution uses
electronic submission software, it should guide you in providing all
necessary documentation for a compete submission. The IRB office's
website may list approximate IRB review timelines; if not, you or your
faculty advisor can contact the IRB to inquire when you might receive
feedback. If the IRB provides you with feedback, be sure to discuss all
revisions with your faculty advisor before resubmission. If you do not
understand a revision request or reviewer comment, email or call the IRB
for further clarification.

Role of the Faculty Advisor

You may be able to choose your faculty
advisor or the department/college may
assign one to you. If you are able to
choose, talk with other students about
their experiences, so that you select
someone who is knowledgeable about your
field of study, supportive, and involved.
Your faculty advisor will not complete your
IRB submission but should provide
guidance first and foremost in in
developing a study plan that reflects best
practices in the ethical and responsible
conduct of human subjects research. The
advisor should also ensure that you carry
out these practices during the research activities. For instance, advisors
should:

 Ensure you fully understand the importance of the informed

consent process and discuss any necessary additional protections,
depending on your intended subject population.
 Help you develop a secure plan for data storage in compliance with
your institution’s data policies and best practices for securing
potentially sensitive data.
 Verify your institution’s data ownership policies to determine
whether they must retain the raw data from the study or you must
transfer any identifiable data to your faculty advisor prior to
graduation.
 Make sure you secure written permission from institutions, schools,
and/or other sites where research may take place.
  Review initial drafts of your study plan, as well as the final
submission to check for completeness, accuracy, and best practices
in human subject protections.
 Monitor your project as it progresses and ensure you maintain
confidentiality, minimize risks and ensure voluntary participation
and withdrawal.
 Help you report problems or negative events to the IRB right away,
in compliance with institutional policy and federal regulations.
Ideally, your faculty advisor will provide clear guidance and support from
beginning to end. Unfortunately, this standard of advising does not always
occur. If you have difficulty communicating with or reaching your faculty
advisor, or you feel you are not receiving correct information about the
IRB process or human subjects research, contact the IRB for assistance
and ask for a consultation with a staff member.

Department or Faculty Review and Approval

Some institutions involve another layer of review prior to the IRB process.
Check with your department or college to find out whether a department
chair, dean, faculty committee, scientific review committee, or faculty
advisor must review and sign off on your application before submission to
the IRB. This initial review may address scientific merit issues (that is,
whether this research activity is worth completing, given your field),
availability of resources, adherence to departmental policies, or other
departmental issues. Find out the timeline as soon as possible for these
preliminary review requirements because they may impact the larger
timeline for conducting your research.

IRB Review
Check your IRB’s website for deadlines and approximate timelines for
review. You must allow enough time to obtain IRB approval and initiate
your project. IRBs cannot “speed up” your review process nor can they
ever provide retroactive approval if you collect data prior to IRB review
and approval.

At many institutions, experienced IRB staff may initially screen your

submission to ensure it is complete and ready for further review. Some
staff may also determine exemption status or serve as expedited
reviewers. Although IRBs may conduct the review process in multiple
ways, common approaches are:

As mentioned previously, IRBs exist to review and mitigate risk to subjects

and ensure equitable and beneficent research practices. IRBs should not
request revisions to methodology unless the submission is unclear or
incomplete or it poses a significant risk to subjects. Nor should IRBs review
the main study plan application for items like grammatical or spelling
mistakes.

On the other hand, the quality of your submission materials tells the IRB a
great deal about you. If you have missing pieces, inconsistencies, typos,
and grammatical and spelling errors in your protocol, what kind of
researcher will you be in the field? You want to give the IRB confidence
about your professionalism and capabilities based on a well-written,
accurate submission.
In addition, typos and errors in your recruitment materials, informed
consent form, and research instruments may steer potential subjects
away from your study or make them question your credibility as a
researcher. For this reason, and because your status as a student reflects
on the reputation of the institution, IRBs will often ask you to revise any
materials to be seen by potential subjects for accuracy and clarity.

IRB Review Outcomes

After the review process, the IRB may require revisions to help mitigate
risk and/or ensure accuracy in the study plan. Responsibility for
completing necessary revisions lies with the researcher, assisted by the
faculty advisor. Once the IRB determines that all necessary revisions are
complete, it will issue written approval and you may proceed with the
study.

Occasionally, an IRB will defer (or “table” which means review at a later
time) a study that shows high risk to subjects, unclear procedures, serious
omissions, or ethical issues. In these cases, the IRB will notify you of
concerns to address. In the case of a submission reviewed at a convened
meeting, the IRB will reconsider the study plan at its next convened
meeting.

In rare circumstances, the IRB will determine that risks to subjects

outweigh potential benefits to subjects and/or society. The IRB will
“disapprove” the study plan, which means you may not conduct the study
as presented (officials at the institution may not override IRB disapproval)
(45 CFR 46).

It is likely that your study plan will only need minor revisions to meet
approval criteria if you adequately work with your faculty advisor and
consult with the IRB prior to submission.

Post-Approval Research, Reporting, and Status Reports

When you receive written IRB approval, you may begin recruiting subjects
and conducting study procedures. Certain situations require further
interaction with the IRB:
Institutional requirements vary regarding status updates or closeout
reports. Some institutions set student approval expirations in line with
graduation dates, while others may establish an annual review. Closely
read your approval letter for the applicable requirements, work closely
with your faculty advisor throughout each stage, and consult with the IRB
whenever questions arise.

Best Practices in Research Studies

Although institutional requirements and policies may vary, the following

section reviews key elements of a study plan, as well as best practices to
avoid pitfalls in the review process.

Recruitment
The following examples and considerations discuss different subject
recruitment strategies.
 Friends and Family
You may not foresee possible harms when recruiting from a population of
your family and friends. However, when recruiting from known
acquaintances, consider whether the nature of your study might lead
people to share private information about other individuals without their
permission.

For example, what if you ask your aunt whether your cousin might want to
participate in a study about individuals who identify as non-binary? In this
case, you may have unintentionally shared personal information about
your cousin without their permission.

As another example, what if you post a link on social media to an online

survey about legal recreational marijuana use and several of your friends
tag other friends in the comments? Thereby revealing possible underage
drug use or individuals’ private activities that they may not want known
publicly.

Snowball Sampling
With the snowball sampling method, others assist you in the recruiting
process but should rarely provide you with potential subject names or
contact information (for the reasons mentioned earlier about disclosing
personal information without permission). Instead, the best practice for
snowball sampling is to provide a link, an email, or a flyer that others can
distribute to potential subjects, who may then choose to click through (if a
link) or contact you about participation. In this case, the series of events
may reveal activities that certain individuals would rather keep private.

Social Media
In addition to using discretion in providing links to studies, you should also
consider appropriate steps in collecting data from social media platforms.
Generally, if someone expects their posts or photos to be private, you may
not use that information for a study. Similarly, if you must register or
obtain permission to join a group, then you may not gather data about
that group without first disclosing your identity as a researcher and giving
people the option to participate.

Classroom Populations
You might consider asking a current professor or other faculty member to
distribute a survey in the classroom. If a faculty member agrees to let you
distribute a very short survey or announce a link to a study or other study
opportunity, you should take the following precautions:

Subject Pools
Your institution may have student subject pools that you can access for
your research project. Often, students enrolled in introductory courses
(such as introductory psychology) sign up within their department or
school to participate in research projects and learn about the process as it
relates to their field of study. The department or school will have its own
guidelines for whether and how you may access these populations. You
still need IRB approval, even if you recruit from an established subject
pool.
 Undue Influence in General
Always consider hierarchies or influences when thinking through
recruitment.

For example, if you wish to interview staff at a middle school about

whether they feel personally supported by their school administration, do
you have a way to contact them aside from their school email addresses
(which usually are not private, so the district may access employee email)?
Will you meet with them at a location where their principal (or another
supervisor) cannot see who participates?

Whether positive (individuals wish to participate out of belief that it will

gain favor with a superior) or negative (individuals fear repercussions from
a superior for participating), institutional hierarchies can affect how
potential subjects feel about volunteering for a study.

Incentives/Compensation
IRBs must approve any incentives or compensation to subjects during
their review of the study plan. Generally, IRBs discourage incentives for
minimal risk studies, especially those conducted by students (however,
snacks or food served at a focus group does not usually count as an
incentive).

If you feel that a small gift for participating would be appropriate, be sure
to consider the population. For international studies, even items like t-
shirts or pens may create disharmony in small communities if members
believe someone has been shown higher favor. Similarly, clients at a food
bank may feel financial pressure to participate in a survey if they will
receive a $25 gift card for their time. These matters depend on local
context, so if you are not familiar with a certain population, seek expert
guidance to learn about culture and appropriate practices. Always check
with your IRB to find out what institutional policies may affect incentives,
related documentation, and recordkeeping.
 Flyers, Emails, and Social Media Links
The informed consent process (as discussed in the next section) begins
with clear, appropriate recruitment materials, so you should always
include your study’s intent and your contact information. An institution
may also require other information pertinent to subjects on the
recruitment material, including inclusion/exclusion criteria. Your
institution may also require that you put its name or logo on the
recruitment materials and/or indicate the flyers, emails, and other
materials are “IRB approved.” Check with your IRB to determine any
institutional requirements.

Informed Consent Process

Informed consent is not a “one and done”
process, you should view informed consent
as an ongoing process throughout the
study. Individuals should always be
welcome to ask further questions,
reconsider participation, retract certain
data, or withdraw their data after the study
takes place (realistically, however, if
someone completes an online survey that
collects no contact information or direct identifiers, you may be unable to
screen out one individual’s data.

Your consent materials must be clear and understandable to potential

subjects, which means you should use non-technical, straightforward
language with vocabulary around the sixth to eighth grade reading level.
Specific regulations (45 CFR 46) require that you present key information
to facilitate understanding and ensure consent includes sufficient detail to
assist an individual with making a decision regarding participation.

If necessary, translate consent documents into the intended population’s

language or include an interpreter on your research team (there may be
specific regulatory and institutional requirements when recruiting a non-
English speaking population, so consult with your IRB for guidance).
A basic informed consent form will include the following information (as
required by 45 CFR 46) and any other specific institutional requirements.

 Contact information for you, your faculty advisor, and your IRB or
compliance office.
 Information explaining that the subject is being asked to participate
in research, including the purpose of the study, how long the study
will last, and a detailed description of the tasks involved (including
any interventions).
 Risks or discomforts the participant may experience.
 Potential benefits to subjects or others.
 The degree of confidentiality a subject can reasonably expect, which
includes who will have access to the data, where and how you will
store data, how you will report data/results (for example, in
aggregate or using pseudonyms), and how you will use results (such
as in reports, publications, or presentations).
 A statement that the individual’s participation is voluntary, refusal to
participate will not negatively impact the individual, and the
individual may stop the study at any time without consequences.
 Any appropriate alternative treatments that may be advantageous
to the subject instead of the research.
 For research greater than minimal risk, an explanation about
available compensation and/or medical treatments if injury occurs,
as well as where participants may obtain further information.
 For research that involves the collection of identifiable private
information or biospecimens, a statement about possible future
research studies and sharing information or biospecimens with
other researchers.
Note: The regulations may require additional consent elements, as
applicable.

Alternatives to Standard, Written Consent

For certain minimal-risk studies, your IRB may approve or even suggest
alternatives to standard, written consent, provided the alteration will not
impact the subjects’ rights. The following circumstances may merit an
alternative to a signed consent document:
When using non-location surveys (such as mailed, emailed, or online), you
must still provide a brief overview of the study’s purpose, risks, and
benefits, as well as your contact information. In the case of a non-location
survey, returning or completing the survey represents that the subject
consented and is an adult in that jurisdiction.

For certain populations, obtaining written consent itself may pose a risk.
For example, these populations may include indigenous peoples who do
not have or who may mistrust written language or people who wish to
preserve anonymity of data (such as individuals who have undocumented
status). In these cases, after you explain the study in language appropriate
for the population, you should indicate in your notes that the subject
understands the study and has given oral consent to participate. If you will
conduct audio or video recording, you should record the oral consent.

For minimal risk studies on benign topics or for studies that collect no
direct identifiers or too few indirect identifiers to determine an identity,
you may request to give potential subjects a study “information sheet”
(including standard consent information). In these cases, an individual’s
decision to participate represents consent.

Typically, individuals provide consent. However, for research studies with

minors (under the legal age to consent and generally 18 years old in most
of the U.S.), you usually must obtain parental permission. Minors provide
“assent” rather than “consent.” You should write the assent materials at an
appropriate language level, depending on the subjects’ age. Additionally,
you should check with your IRB regarding required parental signatures.
In some cases, an individual will have a legally authorized representative
(LAR) who may provide consent on the individual’s behalf. If you encounter
this scenario, your faculty advisor and IRB will help you establish
appropriate steps.

Anonymity, Confidentiality, and Privacy

This section explains the difference between anonymity, confidentiality,
and privacy, so that you can learn how to protect subjects’ private
information.

A good rule to follow is “Never gather more data

than you truly need to answer your research
question(s).”

Two important concepts lie at the heart of this discussion:

Direct identifiers may directly identify an individual. You should only

collect them when necessary, particularly in connection with personal
information. HIPAA’s 18 personal identifiers are “protected” and can be
seen as direct identifiers.

The Health Insurance Portability and

Accountability Act (HIPAA) of 1996 is a federal law
that generally prohibits healthcare providers from
disclosing protected health information (PHI)
without written consent from the patient. Under
HIPAA, PHI includes 18 personal identifiers such
as an individual’s name, address, phone number,
email address, and driver’s license number.
Indirect identifiers do not directly identify the subjects. However, even
when you do not collect direct identifiers, a combination of other data
might reveal an individual’s identity, especially with small sample sizes.
These data include:

Anonymity
If the data are completely de-identified, they may be anonymous –
meaning you do not know the identity of the respondent in connection
with the data.

Caveats to Understanding Different Identifiability

Levels of Data

 Interviews and video recordings that you conduct in

person can never be “anonymous.”
 Collecting any direct identifiers (such as name,
address, phone number) that link responses to a
specific individual or recording a list of codes
associated with identifiers (such as names) means
those data are not anonymous.
 Focus groups are never anonymous. If a combination
of indirect identifiers (such as gender, race, and age)
could identify a specific individual, particularly within
 study data from small samples, the study is not
anonymous. Online surveys (such as those done using
Qualtrics) can allow for anonymous data collection,
but you must disable the feature collecting IP (internet
protocol) addresses, and ensure that you do not
collect indirect identifiers (such as gender, age, race,
work‐site) that identify specific individuals, particularly
with small, unique populations.

Confidentiality
Confidentiality is an agreement (via informed consent) that potential
subjects’ individual responses and identities (their privacy) will not be
disclosed beyond the research team without explicit permission.

You can rarely guarantee absolute confidentiality and must inform

subjects of this. For example, you cannot control whether members of a
focus group share others’ information. In the case of a subject complaint,
the IRB may need to review data and possibly consult with appropriate
institutional officials (such as legal counsel). In addition, most institutions
require that your faculty advisor has access to raw data, which the
informed consent materials should mention.

Mandatory reporting laws may also impact confidentiality. If someone

voices the intent to harm them self or others, you must report this intent
to authorities. In colleges and universities, your faculty advisor is also a
mandatory reporter in cases of Title IX violations (for example,
discrimination based on sex, instances of sexual misconduct, or abuse).

Transmitting data via the internet (such as online or email surveys or

videoconferencing interviews) always runs a risk of a confidentiality
breach (that is, identifiable information released publicly without the
participant’s permission). You can minimize this risk by encrypting data
transmission.

No time limit exists on the confidentiality of subject data. If you

disseminate your results (such as in a research article, report, or
presentation), you cannot identify subjects without their explicit
permission. You may also not use photos, direct quotes, or descriptive
information that could reveal an individual’s identity if you do not have
permission to do so.

Privacy
In research, you must protect an individual’s privacy, which is the degree
to which a subject has control over sharing personal information (such as
physical, behavioral, or intellectual). The context includes timing, extent,
and environment, during data collection and recruitment.

You must have permission to collect data (such as words or behavioral

observations) for any situation where an individual has a reasonable
expectation that no observation or recording will occur. An individual
would not have a reasonable expectation of privacy if engaging in loud
conversations or actions in places such as public transportation or the
grocery store. However, in a classroom, church service, or closed online
group, a person expects privacy and would not expect anyone to record
notes for research purposes.

General Data Protection Regulation (GDPR) (EU 2016)

The GDPR governs the collection and use of

personal information from all citizens of the
European Union. In short, EU citizens have greater
expectations of privacy and agency over what
happens to their data after collection. You may
not intend to collect data physically in the EU, but
the GDPR even applies to online data collection. In
other words, if you share a link via social media
and any individuals in the EU somehow
participate in your study, you are bound by this
regulation (which carries significant penalties for
noncompliance). At this stage, you may wish to
avoid any possibility of EU subjects, unless you
specifically need to recruit from that population. If
so, work closely with your IRB to ensure full
 compliance with GDPR.

U.S. State and Local Laws

In the U.S., additional state and local laws may

also exist to protect privacy.

Data Security and Storage Considerations

A best practice when handling subjects’ data is to first review your
institutional data privacy policy and any applicable IRB guidelines. You
should then ask the following questions when designing the project:
Your faculty advisor should have access to any data collected as part of
your research project. Institutional policies on data ownership vary, but all
data should typically be fully deidentified or transferred to your faculty
advisor’s possession prior to graduation.

The following sections describe the data security and storage

considerations for different types of data.

Paper, Audio, or Video Recordings

You can scan this type of data into an electronic format or store it in a
secure location or keep it in a locked filing cabinet in a secure office. Read
more on paper, audio, or video recordings.

Electronic Data
You can secure electronic data by limiting access to authorized persons, as
identified in your study plan and on the informed consent form. Review
some more considerations for storing electronic data.

Coded Data
To further protect an individual’s data, you might wish to replace
identifying information (such as names, addresses, or birthdates) with a
code involving some combination of letters or numbers. You would then
maintain a separate list with a code key, so you can use that key later to
link identities and responses, if necessary.

If you wish to conduct longitudinal studies, where subjects complete

multiple surveys, but you do not wish to collect direct identifiers, consider
asking them to create an easily remembered code (such as the first three
letters of a parent’s or pet’s name plus the last four digits of their cell
phone number).

Non-Identifiable or Deidentified Data

IRBs consider data non-identifiable if:
You can de-identify data by removing all potential identifiers (direct or
indirect) in a manner that prevents you or anyone else from re-identifying
data in connection with an individual. Keep in mind that as technology
records more of our personal lives, true deidentification and anonymity
become more elusive.

Deception in Research
In some cases, you may wish to deliberately withhold information from
subjects to collect data that is not influenced by participant knowledge of
the research goal. Before approving “deception” methodologies, the IRB
will assess whether:

Some deception studies will require convened IRB review due to potential
risks to subjects, while others may meet exemption criteria due to a lack
of significant risk.

International Research
Research involving human subjects outside of the U.S. may require
additional protections to account for differences in language, culture, and
social expectations. If you plan to conduct research outside of the U.S.,
you will need to provide additional information to the IRB to explain how
you will address these differences.

Most submissions need prior approval from the appropriate authority,

institution, or IRB equivalent in the country where you hope to collect
data. If no equivalent ethics committee or group exists, you will likely need
to demonstrate “local approval” from local experts or community leaders.

Federal regulations add further stipulations for conducting research

outside of the U.S., including (45 CFR 46):

The Office for Human Research Protections provides further resources

on international research. You should also check with the education or
study abroad office at your institution for any international travel policies
that might require additional approval for student, faculty, or staff travel
to high-risk areas (such as export control policies).

Reasonable Risks and Benefits

You must design and conduct studies that minimize potential risks of
harm to subjects. In fact, IRBs will approve studies where the risks are
minimized and reasonable in relation to anticipated benefits (45 CFR 46).
 Risks of Harm
The Common Rule defines minimal risk as
“the probability and magnitude of harm or
discomfort anticipated in the research are
not greater in and of themselves than
those ordinarily encountered in daily life or
during the performance of routine physical or psychological examinations
or tests” (45 CFR 46) (Note – there is a slightly different definition of
minimal risk for prisoners in the federal regulations).

The terms “ordinarily encountered” or “routine” may have broad

interpretations. Thus, trained IRB members and staff assess study plans
based on reasonable risk, which considers both the likelihood and
magnitude of an event. For example, in a study that measures the
maximum amount of oxygen athletes use during intense exercise, one risk
of great magnitude could be cardiac arrest. Yet the likelihood of this event
occurring among trained athletes who regularly engage in intense
workouts is small. An IRB might approve this study, provided that the
informed consent form clearly lays out all risks to subjects, and the
researchers establish correct measures for appropriate monitoring.

Biomedical studies typically pose greater potential risks of physical harm

to subjects, but social and behavioral studies also involve risks, often of a
psychological, social, or economic nature.

For many student projects, participation may lead to only slight emotional
or psychological risk. In these cases, your consent form should let
potential subjects know that they could become upset or feel distress or
embarrassment. In addition, the IRB may ask you to have a list of
resources available to subjects who experience emotional distress.

Another risk is the possibility of a confidentiality breach. Especially in

social and behavioral research, the disclosure of certain data could
jeopardize a person’s reputation, social standing, or employment. On the
other hand, you may need to breach confidentiality if you learn
information about child or elder abuse or other illegal behavior. In some
cases, such as with political or social activists, subjects may wish to
disclose sensitive personal information, and even have their names and
identities associated with the data, because they believe their role calls for
such transparency.

If your informed consent form details potential risks of harm, including

situations in which you might need to breach confidentiality, then your
potential subjects can make the informed decision whether to take part in
the study. The informed consent form should represent a contract of
confidentiality and ethical principles between you and the subjects.

Potential Benefits
Certain interventions may provide immediate or direct benefit to
individual subjects. However, research studies often occur as part of a
larger investigation within a field and may offer insights to that field or
society. In these cases, your informed consent form should refer to
reasonable benefits.

Students who intend to conduct a limited study with a small population

often state in the study plan and on the consent form that the study will
“fill a gap” in the field by “including marginalized voices” on a certain topic.
While the study might indeed provide more insights from a small
population, it is unlikely to fill any gaps in larger societal conversations.

Be realistic about what the study may achieve and limit your claims to
reasonable expectations. Even if a study generates important information,
it may take years for dissemination in the field or to create any
measurable impact.

Remember that you should never list incentives and compensation, as

well as food or other minor amenities, as benefits in the study plan or the
informed consent form. Additionally, you should not consider it a benefit if
subjects find participation rewarding or therapeutic or derive pleasure
from helping.

Students as Research Subjects

In an academic setting, you might have the
opportunity to both conduct research and
participate as a research subject. For
example, students often play an integral
role in research that examines teaching
methods, curricula, and other areas related
to the scholarship of teaching and learning.

As you learned previously in this module,

voluntary participation is a key principle of
human subject protections, based on full
and accurate information. This same
principle applies to you as a research subject! If a faculty member wishes
to recruit students for a research project, you should understand some
best practices to ensure that the researcher respects your rights (and
those of your fellow students). Ideally, the research project should relate
to the topic of a class, and participation should be part of the learning
experience for students.

Learn more about students as research subjects

If you or any other student feel you have been coerced to participate or
continue in a study, or that your grade or class standing has been affected
by your decision, you should talk to your institution’s IRB or compliance
office.

Student "Subject Pools"

As noted earlier, sometimes departments/schools create "subject pools,"
where students in introductory courses learn about research firsthand by
signing up to participate in research projects. Researchers who wish the
convenience of recruiting from these subject pools must submit their
studies (usually exempt or expedited only) for IRB review and approval.
Departments/schools may have certain expectations for what types of
research may be conducted in this manner and specify who has access to
participants.
 Students in Research

Summary

This module provided information on the history and ethical principles of

human subjects research and practical tips for navigating the IRB process.

You should now understand basic concepts, terminology, and strategies

involved in developing and submitting a study plan to the IRB that offers
appropriate protections to human subjects, in line with U.S. federal
regulations and institutional policies.

Above all, contact your reviewing IRB at any stage of the process to seek
guidance and assistance as you prepare to conduct your own human
subjects research project.
History and Ethical Principles – SBE

Introduction
Research with human subjects has a long
and often troubled history in the U.S. and
throughout the world. Chances are you
already have heard of some of the most
egregious and well-known examples of
unethical research in the biomedical
sciences, such as the experiments conducted by Nazi doctors and
scientists on concentration camp prisoners during World War II, and the
U.S. Public Health Service Syphilis Study at Tuskegee (Tuskegee Study).
These abuses led to the creation of codes of research ethics in Europe and
the U.S.

In the wake of the Second World War, the subsequent Nuremberg Trials
on war crimes produced the Nuremberg Code, which outlined ten points
for conducting ethical research with human subjects. Nearly two decades
later, the World Medical Association (WMA) developed a code of research
ethics known as the Declaration of Helsinki, published in 1964 and
subsequently revised. This document is built on both the Nuremberg Code
and the physician's code of ethics known as the Declaration of Geneva.

In the U.S., news that researchers deceived and withheld treatment from
subjects who suffered from syphilis in the PHS Tuskegee Study led to the
creation of the National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research (National Commission or "the
Commission"). The Commission was charged with establishing a code of
research ethics for U.S. research involving human subjects.

In 1979, the Commission issued the Belmont Report, the foundational

document of the current system of U.S. human subjects protections.
The Belmont Report outlines three key ethical principles for conducting
research with human subjects:

 Respect for persons

 Beneficence
 Justice
The Belmont Report informed the U.S. Department of Health and Human
Services (HHS) Code of Federal Regulations (45 CFR 46), which was created
in 1974 and later revised. In 1991, Subpart A of these regulations "Basic
HHS Policy for the Protection of Human Research Subjects" was adopted
by 15 federal agencies and became known as the Common Rule. In 2017,
HHS and 15 other federal agencies issued a revision to 45 CFR 46, Subpart
A to strengthen human subject protections, as well as improve efficiency
in research administration and operations. 20 agencies (including HHS)
intend to follow the revised Common Rule (OHRP 2018).

Landmark social sciences studies such as Milgram's Obedience to

Authority study, Zimbardo's Stanford Prison Experiment, and Humphreys'
Tearoom Trade study, made it clear that social and behavioral research
may carry risks of harm related to psychological well-being, violations of
autonomy and privacy, and reputational damage. Despite good intentions
and best efforts, researchers are not always able to anticipate risks of
harm. This module aims to bring human subjects protections into focus
for researchers in the social and behavioral sciences, education, and
humanities, by examining the complex issues raised by research with
human subjects and how these issues may be addressed using the ethical
principles outlined in the Belmont Report.

Excerpts from the Belmont Report appear in this module in italics. The full

report (approximately seven pages long) provides the conceptual
foundation for the federal regulations and is recommended reading.

Learning Objectives

By the end of this module you should be able to:

 Understand the historic context of the Belmont Report.

  Identify the three ethical principles described in the Belmont Report.
 Describe the relationship between the Belmont principles and
federal regulations.
 Discuss examples of how the ethical principles can be applied to
research in the social and behavioral sciences, education, and
humanities.

Ethical Principles of the Belmont Report

Respect for Persons

Respect for persons incorporates at least two ethical convictions: first, that
individuals should be treated as autonomous agents, and second, that
persons with diminished autonomy are entitled to protection. The principle of
respect for persons thus divides into two separate moral requirements: the
requirement to acknowledge the autonomy and the requirement to protect
those with diminished autonomy (The National Commission 1979).

Autonomy

Autonomy means that people must be empowered to make decisions

concerning their own actions and well-being. According to the principle of
respect for persons, researchers must acknowledge the "considered
opinions and choices" of research subjects. In other words, individuals
must be given the choice whether to participate in research, and they
must be provided sufficient information and possess the mental
competence to make that choice.

Respect for persons also recognizes that some individuals may not be
capable of making decisions or choices that are in their best interest.
Individuals with "diminished decision-making capacity" may lack the ability
to comprehend study procedures or how participating in a study might
adversely affect them. Special care should be taken to protect those with
diminished capacity to the point of excluding individuals who are not able
to give meaningful consent to participate in research.

Children are a class of research subjects with limited autonomy. Typically,

a parent or legal guardian must give permission for a child to participate
in a study. Researchers also should ask child subjects for their assent by
explaining the study in terms they can understand.

Voluntariness

Voluntariness is an essential component of respect for persons. Research

subjects must be free to choose to participate in research. They also must
be free to end their participation for any reason, without consequences.
Voluntariness means more than offering people the choice to participate
in or withdraw from research. Researchers should be aware of situations
in which prospective subjects may feel pressured to participate in a study.
In situations where a relationship between the researcher and subjects
already exists, such as when a volunteer at a homeless shelter decides to
conduct research with that population, the lines between voluntariness
and undue influence may be blurred. People might be reluctant to decline
participation if they have come to know the researcher in another role.

Other examples of situations in which researchers may exert undue

influence because they are in positions of authority include:

Informed Consent

A prospective research subject's autonomy is honored through the

process of informed consent. The Office for Human Research Protections
(OHRP 2014) offers these guidelines:

“The informed consent process involves three key features: (1)

disclosing to potential research subjects information needed to
make an informed decision; (2) facilitating the understanding of
what has been disclosed; and (3) promoting the voluntariness of the
decision about whether or not to participate in the research.”
Researchers must provide certain essential points of information, such as:
The HHS regulations (Protection of Human Subjects 2018) require that the
prospective subject be provided with information that a reasonable
person would want in order to make an informed decision. Further, key
information essential to decision-making should receive priority by
appearing at the beginning of the consent document and being presented
first in the consent discussion.

Informed consent also must be comprehensible to prospective subjects.

Comprehension is the ability to understand what one is being asked to do,
as well as the implications of any risks of harm associated with
participating in the research. Comprehension may depend on an
individual's mental capacity, but it also relates to the comprehensibility of
the informed consent document, or, in the case of oral consent, the script.
Researchers should create consent processes that are at an appropriate
language level for the subject population. Study information can be
presented in a conversational style that is easily understood by a wide
range of individuals. In general, an eighth-grade reading level or lower is
advised.

When conducting research in a language other than the researcher's

native language, the researcher needs to ensure that translations are
accurate and in the appropriate dialect and address idiomatic expressions
that may not make sense in another language. The 2018 revisions to the
Common Rule also noted that there may be subjects from a community or
group where signing forms is not the norm. Researchers should consider
requesting, from the reviewing IRB, approval of an appropriate alternative
mechanism for documenting that informed consent was obtained
(Protection of Human Subjects 2018).

The Principles in Practice

In Laud Humphreys' study, detailed in his book Tearoom Trade: Impersonal

Sex in Public Places, the researcher observed men meeting other men for
casual sexual encounters in public restrooms. Humphreys, then a
sociology graduate student, gained the confidence of the men by
pretending to be a participant and acting as a lookout. While Humphreys
eventually revealed himself as a researcher to some of the men and was
able to interview them openly, he withheld his identity from many others,
recording the license plate numbers of a subset of 100 other tearoom
regulars in order to contact them for interviews at a later date.

A year after completing the observational part of the study, Humphreys

followed up with these subjects, including them in a separate social health
study that enabled him to conduct in-home surveys and gather data about
their family relationships and religious background. In a 1970 article taken
from his book, Humphreys maintained that the researcher's obligation to
protect respondents from harm was a critical ethical assumption. To avoid
being recognized by the interview subjects, Humphreys changed his
appearance and the kind of car he drove.
 “I already knew that many of my respondents were married and that
all were in a highly discreditable position and fearful of discovery.
How could I approach these covert deviants for interviews? By
passing as deviant, I had observed their sexual behavior without
disturbing it. Now, I was faced with interviewing these men (often in
the presence of their wives) without destroying them” (Humphreys
1970).
Although the resulting book, based on Humphreys' dissertation, may have
been beneficial in dispelling some stereotypes, the research violated the
autonomy of the individuals who became part of Humphreys' study
without their knowledge.

Humphreys' research occurred in a different regulatory environment,

prior to the creation of the National Commission and the codification of
federal regulations protecting human subjects.

A more recent example of research that obtained personal information

about individuals without their knowledge is the "Tastes, Ties, and Time
(T3)" study (2006-2009). Sociologists gleaned voluminous and detailed
personal information from the Facebook profiles of an entire class of
undergraduates and followed those students over four years. The
research team created an extensive data set that included students’
gender, home state, major, political and group affiliations, friend
networks, photographs, and tastes in music, books, and film. In 2008, the
researchers made the data publicly available through the Dataverse
Network Project. Although no students were identified by name, some
data were specific enough to allow for re-identification of students by an
outside researcher (Zimmer 2010; Parry 2011).
In both of these studies, the ethical concerns are invasion of privacy, lack
of informed consent, and a failure to protect against deductive disclosure
of identity.

Beneficence
Persons are treated in an ethical manner not only by respecting their decisions
and protecting them from harm, but also by making efforts to secure their
well-being. Such treatment falls under the principle of beneficence. The term
'beneficence' is often understood to cover acts of kindness or charity that go
beyond strict obligation. In this document, beneficence is understood in a
stronger sense, as an obligation. Two general rules have been formulated as
complementary expression of beneficent actions in this sense: (1) do not harm
and (2) maximize possible benefits and minimize possible harms (The
National Commission 1979).

Minimizing Risks of Harm and Maximizing Possible Benefits

Most research in the social and behavioral sciences, education, and

humanities, does not provide direct benefit to subjects, and risks of harm
tend to be minimal. Even so the goal for researchers is to conduct
research where risks to subjects are reasonable in relation to anticipated
benefits.

The most common risks of harm are psychological distress surrounding

sensitive research and inadvertent disclosure of private identifiable
information.

Studies of sexuality, mental health, interpersonal violence, and illegal

activities may create feelings of distress, as well as risk of embarrassment
and reputational harm if private information that would not ordinarily be
shared with a stranger or outsider, becomes public. Researchers may
choose to use pseudonyms in an effort to protect the privacy of subjects,
but other bits of information, taken alone or in combination, may be
enough to allow for re-identification of subjects.

A great deal of research in the social and behavioral sciences, however,

involves minimal risk procedures, such as gathering and reporting on
aggregate data using surveys and interviews.

Some research involves deception, which is permissible, if researchers

provide justification for the deception and prepare debriefing procedures
for the subjects at the end of the study that describe the deception and
explain the scientific rationale for its use (for exempt research under
Category 3 using deception, the subject must authorize the deception
prior to its use).

Frequently, it is not the nature of the data collected but what the
researcher does with the data that carries the most risk of harm for
subjects. Data security and the very notion of privacy have changed
dramatically with the explosion of social media, cloud storage, data mining
of web-based information, and re-identification techniques.

Refraining from collecting subject names is a simple way of reducing risk

of harm due to inadvertent disclosure of private identifiable information.
As we have seen from the T3 study, however, that is rarely sufficient as
data re-identification has emerged as a growing computer science
specialization. Latanya Sweeney (2000), director of the Data Privacy Lab at
Harvard University, has demonstrated that 87 percent of Americans can
be uniquely identified by only three bits of demographic information: five-
digit zip code, gender, and date of birth.

The Principles in Practice

Social and behavioral sciences research has the potential to cause

psychological and even physical distress.
One example is, "The Stanford Prison Experiment," Philip Zimbardo's 1971
landmark psychological study of the human response to captivity,
specifically prison life. Zimbardo assigned roles to male student
volunteers to create groups of "prisoners" and "guards." The simulation
became so intense that physical and psychological abuse of "prisoners" by
"guards" escalated and several of the subjects experienced distress less
than 36 hours after the study began. Zimbardo's study, like Humphreys'
study, occurred in a different regulatory environment, before the advent
of the Belmont Report. Zimbardo did submit his research plan to an ethics
board, but the consent process contained no provisions allowing subjects
to withdraw at will, and no risks of harm beyond loss of privacy were
addressed. According to Zimbardo (2012), the consent form signed by the
subjects only allowed them "to be released from participation for reasons
of health deemed adequate by the medical advisers to the research
project or for other reasons deemed appropriate by Dr. Philip Zimbardo."
Zimbardo did not stop the experiment until six days had passed.

Other risks of harm may be social or reputational. With the publication of

the 20th anniversary edition of her 1977 book, Saints, Scholars, and
Schizophrenics: Mental Illness in Rural Ireland, ethnographer Nancy Scheper-
Hughes reflected upon failing to protect the confidentiality and dignity of
her subjects who felt that she had violated their trust and depicted the
community in an unflattering light. Scheper-Hughes commented in her
written account that, in retrospect, the use of pseudonyms and misleading
indirect identifiers were inadequate as confidentiality measures because
the subjects were easily able to identify themselves and their neighbors.
 I would be inclined to avoid the "cute" and "conventional" use of
pseudonyms. Nor would I attempt to scramble certain identifying
features of the individuals portrayed on the naïve assumption that
these masks and disguises could not be rather easily de-coded by
the villagers themselves. I have come to see that the time-honored
practice of bestowing anonymity on "our" communities and
informants fools few and protects no one-save, perhaps, the
anthropologist's own skin (Scheper-Hughes 2000).

Studies focusing on political violence or other illicit activities may expose

subjects to legal harms. The legal issues surrounding the "Boston College
Oral History Archive of the Troubles in Northern Ireland" demonstrate the
difficulty of promising confidentiality to subjects. Former members of the
Irish Republican Army (IRA) agreed to be interviewed only if their accounts
would remain sealed until their deaths. Subsequently, in response to a
subpoena from the British government, the institution was ordered to
turn over 85 interviews of former IRA members for use in Britain's
investigation of unsolved murders (Dwyer 2011).
 Justice
Who ought to receive the benefits of research
and bear its burdens? This is a question of
justice, in the sense of "fairness in
distribution" or "what is deserved." An
injustice occurs when some benefit to which a
person is entitled is denied without good
reason or when some burden is imposed
unduly  (The National Commission 1979).

Distributing Benefits and Burdens of Research

Justice requires that the benefits and burdens of research are equitably
distributed -- that is, no individual or population is exposed to risks of
harm while other individuals or populations receive the benefits. One
example is cited in the Belmont Report  (The National Commission 1979):
"During the 19th and early 20th centuries the burdens of serving as
research subjects fell largely upon poor ward patients, while the benefits
of improved medical care flowed primarily to private patients." The
Tuskegee Study and the Nazi experiments on concentration camp
prisoners are well-documented examples of research injustices.
Similarly, researchers are discouraged from using prisoners, literally a
captive population, as research subjects merely because they are a
convenient study population. Other examples of populations chosen for
convenience would be professors conducting research on their own
students, or a researcher including subjects only on a particular social
media platform because it is the most convenient (not because it is an
adequate sample population for the research).

In the context of examples such as the Tuskegee Study and the Nazi
experiments, injustice is obvious. In non-medical research, however, the
issue of justice presents in more nuanced ways. Lawrence O. Gostin, a
professor of global health law at Georgetown University, speaks to an
ethical duty to research subjects that goes beyond non-harming.

In thinking about justice toward subjects, researchers need to

consider equitable selection so that individuals are chosen on the
basis of factors clearly relevant to the problems being studied.
Researchers also need to consider equitable distribution of
advantages to research subjects and others who could benefit from
the knowledge gained by the research (Gostin 1991, 191-201).
Psychologist Joan E. Sieber maintains that the research question itself, as
well as the interpretation of the data, may contain an inherent bias that
singles out a particular group of subjects and leads to, or reinforces,
unjust treatment of that group: "One historically sensitive area of the
application of research findings is examining racial differences. Another
example relates to the use of psychological test results in order to
promote a policy of sterilization for the mentally retarded population"
(Sieber and Stanley 1988).

On the issue of justice, Sieber summarizes:

 Justice and equitable treatment refer to issues of procedural and
distributive justice that may arise at any stage of the research
process. An idea that creates prejudices against some sector of
society is unfair. An experimental treatment is also unfair if
resources known to be vital to subjects' well-being are withheld
from subjects in one group and given to those in another.

The Principles in Practice

In educational research testing (such as a new curriculum or teaching

method), subjects in the treatment group may derive benefits from the
intervention while subjects in the control group do not have access to that
intervention. If the program being tested is specific to that age group, the
control group participants would not have the opportunity to benefit from
that intervention in the future. To fulfill the Belmont principle of justice,
the control group must receive standard instruction.

Balancing the Three Principles

It was the National Commission's intention that each of the three

principles should have equal moral force. This means that in some
situations, the three principles might be in conflict with one another. For
example, we might derive from the principle of respect for persons that
we should limit the involvement of children in research because children
are unable to choose for themselves. However, we might derive from the
principle of justice that we must involve children in studies so that
children will have the opportunity to benefit from the research.
The Belmont Report states that one principle does not always outweigh
another. Rather, we are required to consider each case separately and on
its own merits while seeking to uphold all three principles.
The issue of deception in research illustrates this tension between
principles. When an Institutional Review Board (IRB) feels the use of
deception is justified because the research question could not be
answered if subjects were fully informed but there are potential benefits,
the principle of beneficence holds greater weight than that of respect for
persons. For example, deceptive experimental manipulations may be used
to make subjects feel rejected in order to study the effects of social
rejection.

The Belmont Report and the Common Rule

The Common Rule (Protection of Human Subjects 2018) lists criteria for
IRB approval of a research plan that are directly related to the three
Belmont principles.

Respect for Persons

  Informed consent will be sought from each prospective subject or
the subject's legally authorized representative, in accordance with,
and to the extent required by 46.116.
 Informed consent will be appropriately documented, in accordance
with, and to the extent required by 46.117.
 When appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
 When some or all of the subjects are likely to be vulnerable to
coercion or undue influence, such as children, prisoners, individuals
with impaired decision-making capacity, or economically or
educationally disadvantaged persons, additional safeguards have
been included in the study to protect the rights and welfare of these
subjects.

Beneficence
 Risks to subjects are minimized: (i) By using procedures which are
consistent with sound research design and which do not
unnecessarily expose subjects to risk, and (ii) whenever appropriate,
by using procedures already being performed on the subjects for
diagnostic or treatment purposes.
 Risks to subjects are reasonable in relation to anticipated benefits, if
any, to subjects, and the importance of the knowledge that may
reasonably be expected to result. In evaluating risks and benefits,
the IRB should consider only those risks and benefits that may result
from the research (as distinguished from risks and benefits of
therapies subjects would receive even if not participating in the
research). The IRB should not consider possible long-range effects of
applying knowledge gained in the research (for example, the
possible effects of the research on public policy) as among those
research risks that fall within the purview of its responsibility.
 When appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects.
 When appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.

Justice
  Selection of subjects is equitable. In making this assessment the IRB
should take into account the purposes of the research and the
setting in which the research will be conducted and should be
particularly cognizant of the special problems of research involving
vulnerable populations, such as children, prisoners, individuals with
impaired decision-making capacity, or economically or educationally
disadvantaged persons.

History and Ethical Principles

Summary
Historical events and contemporary abuses inform the development of
ethics related to the protection of human research subjects. The Belmont
Report, along with federal regulations and professional codes of ethics,
offer guidance for IRB review, based on three key ethical principles:
respect for persons, beneficence, and justice.
Defining Research with Human Subjects – SBE

Introduction
The federal regulations define both "research" and "human subject."
Studies must be reviewed by an Institutional Review Board (IRB) only if
both definitions apply.

A study that meets the federal regulation’s definition of research, but does
not involve human subjects, does not need IRB review. Similarly, a study
may involve human subjects, but not meet the definition of research and
would, therefore, not require an IRB review.

This module interprets words and phrases used in the definitions of

research and human subject from the perspective of research in the social
and behavioral sciences, education, and the humanities.

Learning Objectives

By the end of this module, you should be able to:

 Explain the definition of research.

 Explain the definition of human subject.
 Describe the differences between private and public information
and behavior.

Defining Research
Research is defined by federal regulations at 45 CFR 46.102 (Protection of
Human Subjects 2018), as "a systematic investigation including research
development, testing, and evaluation, designed to develop or contribute
to generalizable knowledge."

This definition was revised in the 2018 Requirements version of the

Common Rule to specifically exclude the following activities:

 Scholarly and journalistic activities (for example, oral history,

journalism, biography, literary criticism, legal research, and historical
scholarship)
 Public health surveillance activities
 Collection and analysis of information, biospecimens, or records by
or for a criminal justice agency for activities authorized by law or
court order or criminal investigative purposes
 Authorized intelligence, homeland security, defense, or national
security mission operational activities
Note: For research subject to the pre-2018 Requirements version of the
Common Rule, the definition of research does not specifically exclude
those activities. It is important to know which set of requirements applies
to each individual research study.

Systematic Investigation
The definition of research starts by stating that the activity must be a
systematic investigation. A systematic investigation is the opposite of a
disorganized, random venture. In other words, researchers need to have
constructed a research plan with ideas about what they want to learn and
how best to do that.

Both qualitative and quantitative researchers use systematic investigation

in the course of their research. Both types of research are organized,
albeit around differing notions about the role of the researcher, the
purpose of the research, the nature of the data collected, and so on.

Quantitative researchers may test hypotheses and theories with the data
they collect, while qualitative researchers may generate hypotheses or
theories based on the data they gather.
Quantitative researchers may focus on statistical analyses based on
precise measurements; however, it is not necessary for precise, replicable
measurements to be collected in order for research to be considered
systematic.

Including Research Development, Testing, and Evaluation

It is important to understand what activities qualify as “research
development, testing, and evaluation” under the definition of research.

Pilot studies and other preliminary studies fall under the definition of
research. Both of the following preliminary components of a study
constitute research with human subjects:

 Convening a focus group to help researchers develop a

questionnaire
 Pilot testing a questionnaire

Designed to Develop or Contribute to Generalizable

Knowledge
The definition of research requires that the
activity is “designed to develop or
contribute to generalizable knowledge”
(Protection of Human Subjects 2018).

To generalize is to derive general

conclusions from particulars. Although
some qualitative research may be less
generalizable than some quantitative
research, it is not the case that only
hypothesis-driven, replicable research may
be considered generalizable. Even research
about the most narrowly defined topic
(such as, an individual case study or an
isolated community study) may be
intended to contribute to a body of
knowledge (such as, the function of culture, expression of gender, or
political views of marginalized community members).

There is no regulatory guidance on the meaning of generalizability. The

essential consideration is whether it was the researcher's intent to
contribute to a body of knowledge or whether the results were replicable.
It really depends on the intent.

The definition of research excludes certain scholarly and journalistic

activities that collect and use information with a “focus directly on the
specific individual about whom the information is collected”, not the
generalizability of that information (Protection of Human Subjects 2018).

Some activities that involve interactions with humans and data gathering
may not meet the definition of research because they are designed to
accomplish something else, such as program improvement (also called
quality improvement activities).

For example, university library staff may conduct a survey of members of

an academic unit to find out if the library is meeting the department's
need. The project may be a systematic investigation, but is not considered
research because the intent of the project is to improve the library's
service to its patrons, rather than contribute to a body of knowledge (such
as, improving all libraries’ service methods).

Publication of results is sometimes used, incorrectly, as an indicator that a

project meets the definition of research. It is the intent of the project that
matters. In the example above, the library staff could share the results of
their program improvement activity at a conference without changing the
intent. The project would not become research by virtue of sharing its
results.

Defining Human Subject

According to the federal regulations at 45 CFR 46.102 (Protection of
Human Subjects 2018), a human subject is a "living individual about whom
an investigator (whether professional or student) conducting research: (i)
obtains information or biospecimens through intervention or interaction
with the individual, and uses, studies, or analyzes the information or
biospecimens; or (ii) obtains, uses, studies, analyzes, or generates
identifiable private information or identifiable biospecimens."

The following sections review key words and phrases in the definition.

A Living Individual
Research about deceased people does not meet the federal definition of
research with human subjects.

About Whom
Another key part of the human subjects definition is the “about whom”
wording.

Some research that involves interactions with living individuals does not
meet the regulatory definition of research with human subjects because
the focus of the investigation is not on the opinions, characteristics, or
behavior of the individual. Instead, the individual is asked to provide
information about something. How many micro-loans were made last
year? What is the average amount of those loans? These are not "about
whom" questions, but can be thought of as "about what" questions.
If a researcher calls the director of a shelter for battered women and asks
her for the average length of stay of the women who use the shelter, that
inquiry would not meet the definition of research with human subjects,
even though there is an interaction between the researcher and a living
individual, because the information requested is not "about" the director.
If the researcher interviewed the director about her training, experience,
how she defines the problem of battering, or how she manages stress,
then the inquiry becomes about her - and thus "about whom" - and
therefore, meets the definition of research with human subjects.

Interactions and Interventions

The researcher must obtain the information or biospecimens about the
subjects either by intervention or interaction.

Interventions include:

 Physical procedures through which data are gathered, such as

measuring brain function to supplement paper and pencil inquiries
into the development of language
  Behavioral interventions such as experimental education programs
or unproven psychosocial therapies.
Interventions also include manipulation of the subject or the subject's
environment performed for research purposes, for example, studies
investigating the effect of music on memory.

Interactions include communication or interpersonal contact between

the subject and the researcher. Communication does not have to be face-
to-face, and may even exist entirely on paper or in electronic realms.
Online surveys that do not ask for any identifying information about the
subjects are considered interactions. Participant observation is a variant of
interaction, often including both formal and informal interviews in
addition to observation.

Private Information, Identifiable Private Information, and

Identifiable Biospecimen
The Common Rule provides definitions for
the terms private information, identifiable
private information, and identifiable
biospecimen to help clarify how they are
used in the human subject definition.

As defined in the regulations at 45 CFR

46.102 (Protection of Human Subjects
2018), private information includes:

 "Information about behavior that occurs in a context in which an

individual can reasonably expect that no observation or recording is
taking place, and
 Information that has been provided for specific purposes by an
individual and that the individual can reasonably expect will not be
made public” (for example, a school record).
The regulations further state that identifiable private information is
private information that the researcher can readily identify whom it is
from or associated with.
The regulations provide no explanation of the words "readily ascertained,"
but one can assume that this means the information is available to the
researcher (for example, the researcher has access to the linking code of
subject ID and subject name).

An identifiable biospecimen is just that – a biospecimen that the

researcher can identify whom it is from or associated with. The regulation
uses the wording that the subject’s identify “may readily be ascertained”
but does not say what this means.

The regulation further requires that federal agencies implementing the

Common Rule must reexamine the meaning of “identifiable private
information” and “identifiable biospecimen” regularly, especially in light of
emerging technologies and techniques that can be used for
identification/re-identification purposes (Protection of Human Subjects
2018).

Observing and Recording Private Behavior

It is important to keep in mind that
whether a setting is public, by federal
definition, is determined in large part by
the potential subjects' reasonable
expectations of privacy, rather than any
absolute distinctions between public and
private spaces.

For example, one might expect that certain

behavior, even if conducted in public spaces, is in fact private, such as a
conversation in a public park. It is reasonable to assume that one might
expect not to be taped while dining with a date at a restaurant.

Researchers who wish to obtain information in a context in which subjects

would have a reasonable expectation of privacy, may choose to use covert
observation (concealed audio or video recording devices, or using a one-
way mirror) or assume a role in the setting or group being studied. Such
studies raise significant concerns about violation of privacy and require
additional protections and safeguards for subjects. Observational studies
in quasi-public places, for example, hospital emergency rooms, also may
raise such concerns.

Private Information Provided by Individuals for Specific

Purposes
Individuals, in a variety of settings, provide personal information with the
expectation that it not be made public, such as at work, at school, when
receiving health care, or as a member of an organization.

Some of this personal information is protected by law. Additional laws to

protect individuals’ privacy include:

The Family Education Rights and Privacy Act (FERPA) protects the privacy
of school records. Similarly, the privacy provisions of the Health Insurance
Portability and Accountability Act (HIPAA) protect private health
information. Generally, although there are some exceptions, school and
medical records can only be released with express written permission.

Data files including identifiable private information are compiled and

maintained by both public and private institutions. Owners of identifiable
data impose restrictions on the use of the data they provide researchers.
Institutions may release de-identified data publicly, but only release
identifiable data to researchers with IRB-approved data protection plans.
Revised Common Rule and On-going Research
Revisions were made to update regulations at 45 CFR 46, Subpart A -
"Federal Policy for the Protection of Human Subjects" (the Common Rule)
by the U.S. Department of Health and Human Services (HHS) and other
Common Rule agencies and departments, with a general compliance date
of 21 January 2019. The revised Common Rule is referred to as the “2018
Requirements” and the previous Common Rule is referred to as the “pre-
2018 Requirements.”

On-going research that was initiated, determined to be exempt, or waived

prior to the general compliance date of the revised Common Rule (21
January 2019) is allowed to continue being governed by the pre-2018
requirements for the duration of the research (Protection of Human
Subjects 2018).

Note: This module reflects the 2018 Requirements version of the

Common Rule, not the pre-2018 Requirements version. It is important to
know which rule governs which research and ensure compliance with the
appropriate version of the rule, as there are differences that affect
research conduct and review.

Summary
The definitions of research and human subject are essential for
determining which research activities are subject to regulation and review.
Important concepts include generalizability, identifiability, and public
versus private information.
The Federal Regulations – SBE

Introduction

Revelations in the early 1970s about egregious

medical experiments provided the impetus for
developing federal standards for protecting human
research subjects; however, a close reading of the
regulations at 45 CFR 46 will find mention of research
methods and topics of inquiry relevant to researchers
in the social and behavioral sciences, as well as
education and the humanities. Methods mentioned
include surveys, interviews, focus groups, participant
observation, observations of public behavior, and the
analysis of existing data. Topics include research on perception, cognition,
motivation, identity, language, communication, cultural beliefs or
practices, and social behavior.

In addition to explicitly identifying these methods, the regulations include

provisions that allow for appropriate review of social sciences, humanities,
and behavioral research. For example, the regulations:

 Identify research activities that are low risk (for example, surveys in
which no identifiers are collected), and that are exempt from some
provisions of the regulations (such as the requirement for
continuing review).
 Identify research activities with no more than minimal risk that can
be initially reviewed by one or more Institutional Review Board (IRB)
members, rather than at a convened IRB meeting.
 Allow for waivers of the requirement to obtain written consent (for
example, in a study of undocumented workers).
 Include provisions that permit researchers to withhold information
in the consent process. This provision is important when some
degree of deception is required in order to obtain valid results.
 Allow for the amendment of approved study plans. This process can
be used effectively when it is not possible to know at the outset how
a study will evolve. An example would be field research.
This module provides an overview of the federal regulations, so
researchers can become familiar with the basic provisions. The full text of
the federal regulations is available online.

Learning Objectives

By the end of this module, you should be able to:

 Determine whether proposed research meets the criteria for

exemption.
 Describe the criteria for the use of expedited review procedures and
IRB review.
 Summarize the authority of an IRB.
 Describe the kinds of review that approved research may need.

45 CFR 46: Protection of Human Subjects

U.S. Department of Health and Human Services (HHS) regulations are

sometimes referred to as 45 CFR 46, a label that identifies their location in
the code of federal regulations.

Subpart A of 45 CFR 46 is often referred to as the Common Rule. Although

these regulations were first drafted and adopted by HHS, most federal
departments and agencies that fund research in the social and behavioral
sciences, including the National Science Foundation (NSF) and the
Department of Education (ED) subsequently adopted the regulations as
part of their own codes of federal regulations.

The Common Rule remained largely unchanged until 2017. In 2017, HHS
with 15 other federal agencies issued a Final Rule to update the
regulations. The revisions were designed to strengthen protections for
human subjects, as well as reduce administrative burdens and add
flexibility for the modern research environment. Major changes were
made to requirements for IRB operations, informed consent, definitions,
and exemptions.
The general compliance date for the revised Common Rule was 21 January
2019, and research approved, waived, or determined to be exempt is
governed by the “2018 Requirements” version of the Common Rule.
Ongoing research that was approved, waived, or determined to be exempt
prior to 21 January 2019 can continue for its duration under the “pre-2018
Requirements” or be transitioned to the 2018 Requirements.

This module will refer to the 2018 Requirements version of the Common
Rule, but it is important to understand which version of the regulation
applies to which research, so it may be helpful to check with your
organization and/or the IRB of record for guidance.

Additional Protections for Vulnerable Subjects

Three subparts (B, C, and D) were added to the basic provisions of the
federal regulations to further protect vulnerable subjects in research:

Some federal agencies that adopted the Common Rule also have adopted
some or all of the other subparts of the HHS regulations, but others have
not. For example, while the ED has adopted the additional protections for
children, the NSF has not.

Assurances with the Office for Human Research

Protections (OHRP)
Every institution conducting research with federal support is required to
enter into an agreement called an "assurance." Most assurances are filed
with OHRP. An assurance identifies the regulations for protecting research
subjects that the institution will abide by. In the U.S., this is the Common
Rule.
The assurance only applies to studies that are funded by a Common Rule
department or agency.

Some institutions apply the Common Rule to all research regardless of the
funding source. This means that the Common Rule would apply to
research funded by foundations, associations, internal award programs,
all other sources of research support, and even when research is not
funded. However, the non-federally supported research would not be
subject to OHRP oversight or the assurance.

Some institutions also choose to apply the additional Subparts B, C, and D

to all research regardless of the funding source. Others choose to apply
the subparts only to federally funded research. Once again, this voluntary
application of the regulations would not be part of the assurance.

The assurance also identifies the IRBs that will review research on behalf
of the institution. According to the revised Common Rule, the institution
will no longer have to list all the IRBs that it relies on through reliance
agreements on the assurance.

Content of the Federal Regulations

Portions of the federal regulations most relevant for researchers include:

 What research must be reviewed

 Who must review research with human subjects
 What questions should be addressed during a review
 What kinds of review need to take place during the course of a
project
It is important to note that the federal regulations are intended to provide
minimum standards and may be supplemented by institutional policy.

What Research Must Be Reviewed

The first step in deciding whether a project needs to be reviewed is to
determine whether it meets the definition of research with human
subjects. If it does not meet the definition, it does not require review by an
IRB, although there may be ethical issues that must be addressed by the
researcher's institution.

There are two critical definitions in 45 CFR 46.102.

"Research" means a systematic investigation, including research

development, testing, and evaluation, designed to develop or contribute
to generalizable knowledge.

“Research” Defined as “Not

Research”

Systematic investigation, Scholarly and

including research journalistic activities (for
development, testing, example, oral history,
and evaluation, journalism, biography,
designed to develop or literary criticism, legal
contribute to research, and historical
generalizable scholarship)
knowledge.
Public health
surveillance activities

Collection and analysis

of information,
biospecimens, or
records by or for a
criminal justice agency
for activities authorized
by law or court order or
criminal investigative
purposes

Authorized intelligence,
homeland security,
defense, or national
security mission
operational activities
"Human subject" means a living individual about whom a researcher
(whether professional or student) conducting research:

i. Obtains information or biospecimens through intervention or

interaction with the individual, and uses, studies, or analyzes the
information or biospecimens; or
ii. Obtains, uses, studies, analyzes, or generates identifiable private
information or identifiable biospecimens.
If it has been determined that a project meets the definition of research
and includes human subjects, the next step is to determine the type of
review it needs. The type of review usually determines who will conduct
the review.

Research Eligible for Exemption

Of significant interest to researchers in the social and behavioral sciences
is the fact that there are activities that meet the definition of research with
human subjects but are exempt from the provisions of the Common Rule.
They do not require formal review as described in the regulations.

Many institutions have created review procedures for making the

determination that research is exempt.

Institutional procedures vary, but most commonly it is an agent of the

institution, not the researcher, that makes the determination, because
researchers have an inherent conflict of interest.

Research may be eligible for exemption from the regulations if all the
activities associated with the research fall into one or more of eight
categories. Of the eight categories, social, behavioral, and educational
research typically falls into one of these:

 Research conducted in established or commonly accepted

educational settings, involving normal educational practices.
 Research only involving educational tests, survey procedures,
interview procedures, or observation of public behavior, provided
that at least one of these criteria is met:
o The investigator records the information in such a way that
subjects cannot be readily identified
o Any disclosure of identifiable information outside the research
setting would not place the subjects at risk of criminal or civil
liability or be damaging to the subjects’ financial standing,
employability, or reputation.
o The investigator records the information and the subjects can
be readily identified, and an IRB conducts a limited IRB review.
o Note: If Subpart D applies, either by sponsor requirement or
institutional choice, interviews, surveys, and participant
observation with children as research subjects might not be
exempt under Exempt Category 2 (there are specific
restrictions for Exempt Category 2 research complying with
Subpart D).
 Research involving benign behavioral interventions in conjunction
with the collection of information from an adult subject through
verbal or written responses (including data entry) or audiovisual
recording if the subject prospectively agrees to the intervention and
information collection.
 Secondary research for which consent is not required.
A complete list of research activities eligible for exemption is provided at
45 CFR 46.104.

Expedited Review or Convened IRB Review

If research is not eligible for exemption, the remaining options are
expedited review or convened IRB review for initial approval. Expedited
review is conducted by one or more experienced IRB members. Convened
IRB review is conducted by a quorum of the IRB.
To be eligible for expedited review for initial approval, research must meet
criteria, including the following:

1. Pose no more than minimal risk to subjects

“Minimal risk” means “the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological examinations
or tests” (Protection of Human Subjects 2018).
2. Consist of only one or more research activities specified in the
federal regulations as eligible for expedited review (It may be helpful
to review the Categories of Research That May Be Reviewed by the
Institutional Review Board [IRB] through an Expedited Review Procedure ).
If the primary risk to subjects is a breach of confidentiality and the risk can
be managed to no more than minimal , then the research may be
reviewed through an expedited process.

There are many research activities that are eligible for expedited review.

In addition to studies involving surveys, focus groups, interviews, and

observations of behavior, studies involving the collection of biological
samples and data by non-invasive means may be eligible for expedited
review. Biological samples include saliva and fingernail cuttings or
measures of pesticide exposure using skin patches. Data collected by non-
invasive means includes galvanic skin response, heart rate, and blood
pressure.

A category of research activity eligible for expedited review includes the

collection of blood samples within well-defined parameters based, for
example, on the age of the research population.

Research involving identifiable data collected for non-research purposes

may be eligible for expedited review as may the collection of existing data
from voice, digital, or image recordings made for research purposes.
Institutional policy, local conditions, and subject vulnerability may require
review by the convened IRB even for a study with no more than minimal
risk, such as a study of individuals with impaired decision-making.

If research involves more than minimal risk and/or does not fall into one
of the categories of research eligible for expedited review, it must be
reviewed by a convened IRB. This review involves consideration by a
larger, more diverse group, thus bringing more perspectives and more
experience to the review.

Who must review research with human subjects?

As described in the federal regulations and implemented by institutional
policy, there are three possible sets of reviewers.
 Description of an IRB
An IRB is a review committee established to ensure that the rights and
welfare of human research subjects are protected. Although federal
regulations use the term IRB, institutions may choose a different name for
the committee, such as Research Ethics Board or Independent Ethics
Committee.

Membership
The minimum size and required composition of an IRB is described in
detail in the federal regulations. An IRB must have at least five members
(including a person not otherwise affiliated with the institution, a scientist,
and a non-scientist). The non-affiliated member can also be the non-
scientist or scientist (the individual may be the same person fulfilling two
requirements). Its membership must be diverse, including race, gender,
and cultural background. The committee is expected to:

 Be sensitive to community attitudes

 Have knowledge and experience with vulnerable populations
(persons potentially vulnerable to coercion or undue influence)
 Be conversant with applicable regulations, state and local laws, and
standards of professional conduct
The most important requirement is that an IRB must have the expertise
and professional competence to evaluate the research it reviews. One or
more members must have familiarity with the discipline and methods
under consideration. If not, the IRB must seek that expertise through
consultation. For example, if an IRB reviews research on sensitive topics
using web-based surveys, it must have expertise about security issues in
the internet environment or seek outside consultation.

Authority of the IRB

Federal regulations stipulate that an IRB can:

 Approve research
 Disapprove research
 Require modifications to secure approval
  Conduct continuing reviews
 Suspend or terminate approval
 Observe, or have a third party observe, the consent process and the
research procedures
An IRB must notify researchers, in writing, about the outcome of its
reviews, including modifications required to secure IRB approval of the
research activity. If the IRB decides to disapprove a research activity, the
written notification must provide the reasons for its decision and give the
researcher an opportunity to respond in person or in writing.

Other Institutional Reviews

Research approved by an IRB may be subject to additional review by
institution officials, for example, department heads, deans, or research
directors. The institution may decide that IRB-approved research may not
take place. However, if an IRB has disapproved the research, the
institution may not override that determination.

What questions should be addressed during a review?

Exempt Research
When research is exempt from the provisions of the Common Rule, it
follows that the review criteria provided for expedited review and
convened IRB review would not apply.

For most exempt determinations, an experienced staff member may make

the determination for exemption. However, for limited IRB review, the
determination must be made by an IRB member. Further, in the case of
limited IRB review as a condition for exemption, the IRB reviewer must
review the research per limited IRB review criteria and make the
determinations required for limited IRB review.

All research should abide by the three basic ethical principles outlined in
the Belmont Report: respect for persons, beneficence, and justice. The
principle of respect for persons would entail securing informed consent
from research subjects.
Many institutions have developed forms designed to gather sufficient
information to determine not only that a project is exempt, but also that it
will be conducted in accordance with the basic ethical principles.

Expedited and IRB Review

The same questions must be asked when
an IRB member is conducting an expedited
review and when the convened IRB is
conducting the review.

 Have the risks to subjects been minimized using procedures that are
consistent with sound research design?
 Are the risks reasonable in relation to anticipated benefits?
 Is the selection of subjects equitable?
 Are adequate procedures in place to ensure privacy and
confidentiality?
 Is there a plan to monitor the data and safety of the subjects, if
necessary?
 Will informed consent be sought and appropriately documented? Do
proposed alterations or waivers of informed consent meet the
criteria for approval?
 Are safeguards in place to protect vulnerable populations?

Comparison of Expedited and Convened IRB Review

Review procedures for expedited review and convened IRB review are
similar in several ways:

 The review criteria are the same.

 Reviewers using the expedited review procedure or the convened
IRB can request modifications to research plans and approve the
plans.
A key difference between the two processes is that expedited reviewers
cannot disapprove a research plan. If an expedited reviewer thinks a
research plan is not approvable, the plan must be submitted to the IRB for
review.
Another very important difference is that research initially approved in
accordance with expedited review does not need continuing review. By
regulation, continuing review is also not required for research that is in
data analysis only, or research that is accessing follow-up clinical data only
(Protection of Human Subjects 2018). The IRB may determine otherwise,
however, and require continuing review on a study-by-study basis and
must document how requiring continuing review increases protection for
human subjects participating in the research.

The institution may also require researchers to submit annual progress

check-ins based on institutional policy.

Approved Research: Additional Reviews

Once a research plan has received initial approval through expedited or
convened IRB review procedures, additional reviews may be required.

1. For more than minimal risk research only (approved by an IRB),

continuing review must be conducted at intervals appropriate to the
degree of risk, but not less than once per year.
2. For all research, changes to approved research plans must be
reviewed and approved before implementation.
3. For all research, reports of unanticipated problems involving risk to
the research subjects or others also must be reviewed through
procedures developed by the researcher's institution where the
research is conducted.
Continuing reviews and reviews of proposed amendments to approved
research may be reviewed by the IRB or through expedited review
procedures. The determination about what type of review is appropriate is
based on a number of factors, including the level of risk and the extent of
proposed changes. The IRB or the expediting reviewer(s) must determine
that all the requirements for initial review continue to be satisfied.

Continuing Review: Expedited or IRB Review?

Federal regulations permit expedited review procedures to be used for
continuing review if the initial review was conducted by a convened IRB
under some specific conditions, such as: (1) when during the initial review
the IRB determined that the research involves no more than minimal risk
and no additional risks have been identified, or (2) where no subjects have
been enrolled and no additional risks have been identified (OHRP 1998).

IRB review is required for continuing review for active research studies
that are greater than minimal risk and initially approved by the convened
IRB.

If research that is more than minimal risk is only in data analysis or

collecting follow-up clinical data from subjects, continuing review may not
be required under the regulations, depending on if the research is subject
to the pre-2018 Requirements or the 2018 Requirements version of the
Common Rule.

Amending Approved Research Plans

Changes to approved research plans must be approved prior to their
implementation. The federal regulations (Protection of Human Subjects
2018) state that expedited review procedures may be used to approve
"minor changes in previously approved research during the period (of one
year or less) for which approval is authorized."

What constitutes a "minor" change is not described in the regulations and

therefore, will be a matter of institutional policy.

Reports of Unanticipated Risks or Harms

Institutions that have an assurance with the Office for Human Research
Protections (OHRP) are required to develop written procedures for
reporting and reviewing unanticipated problems involving risks or harms
to research subjects.

Limited IRB Review

There may be cases of research for which limited IRB review is a condition
of exemption. Although not technically an expedited review, this limited
review requires that the IRB reviewer determine that there are adequate
provisions to protect the privacy of subjects and to maintain the
confidentiality of data, among other requirements for the condition of
exemption (Protection of Subjects 2018). Continuing review is not required
for exempt studies approved via limited IRB review.

Other Issues

The federal regulations cover other issues not addressed in this module
such as working with collaborators on cooperative research, international
research (taking place in foreign countries), required record-keeping, and
the suspension or termination of IRB-approved research.

SBE Research as Clinical Trials

Research that meets the definition of a “clinical

trial” is subject to additional regulatory
requirements and policies (as applicable). For
example, Common Rule governed clinical trials
must post informed consent forms on a publicly
available website; and, NIH-supported clinical
trials have additional training requirements (such
as good clinical practice) for key study personnel.

Summary

Federal regulations define which research activities require IRB review, the
types of review, who conducts the review, and the criteria for approval.
Because the federal regulations establish a minimum standard, it is
important to check with your institution to find out if there are additional
procedures and criteria.
Assessing Risk – SBE

Introduction
One of the most important and challenging tasks researchers and
Institutional Review Boards (IRBs) face is identifying and evaluating risks of
harm associated with participation in research. Unlike biomedical
research studies and clinical trials in which the sources of risk may be
more readily identifiable and quantifiable, potential harms associated with
taking part in social and behavioral science research may be more
ambiguous and less predictable, such as individual reactions to certain
events or questions. However, identifying and assessing risks in such
situations should be informed by a growing body of research literature on
risks associated with research participation.

The risks of harm typically associated with social and behavioral research
are social, psychological, economic, and legal in nature. However, in rare
circumstances, the risks may involve physical harm. For example, those
who study victims of domestic violence need to consider that individuals
taking part in the study may become the victims of retaliatory violence if
the subjects' involvement in the research is discovered.

It also is possible that when groups or communities rather than

individuals are the focus of a study, the group as a whole may be at risk of
harm. For example, research on the prevalence of individuals with HIV in
communities may stigmatize the community being studied.

Identification, assessment, and minimization of risk are paramount to the

conduct of ethical social and behavioral research.

Learning Objectives

By the end of this module, you should be able to:

 Identify risks of harm associated with participation in social and

behavioral sciences research.
  Distinguish between probability and magnitude of harm when
assessing risk.
 Apply the concepts of minimizing and managing risk.

Identifying Risks Associated with Participation in Social and

Behavioral Sciences Research
Risks of harm in social and behavioral sciences generally fall into three
categories:

Invasion of Privacy
Invasion of privacy can occur if personal information is accessed or
collected without the subjects' knowledge or consent. For example, if a
researcher studying interaction patterns in an online support group joins
the group and does not reveal her true identity online, the support group
participants could feel that their privacy had been invaded by the
researcher, if or when her true identity as a researcher is revealed to the
group.

Invasion of privacy also can occur if a subject's participation in a study is

revealed despite assurances that this would not happen. For example, a
researcher is studying emotional reactivity in women who have
experienced sexual abuse. The research is conducted in a designated
university lab on a particular day each week. Another university staff
person sees an acquaintance entering the meeting room and therefore
discovers that the acquaintance has experienced sexual abuse.

Breach of Confidentiality
Perhaps the primary source of potential
harm in the social and behavioral sciences
is that information obtained by researchers
could adversely affect subjects if disclosed
outside the research setting. Confidentiality can be compromised through
an unauthorized release of data, which could have a negative impact on
the subjects' psychological, social, or economic status. For example:
 Study Procedures
In some cases, simply taking part in research can put subjects at risk. For
example, if a researcher is conducting interviews with individual gang
members, it may be necessary to find places to meet where other gang
members could not observe the interaction.

Another situation in which merely taking part in research might pose

some risk to subjects is when there is a potential for a breach of
confidentiality, not because of inadequate confidentiality procedures on
the part of the research team, but from subjects themselves when data
are collected in a group setting such as a focus group. Even though
participants typically are cautioned not to share information outside the
data collection setting, subjects should be made aware that the researcher
cannot guarantee confidentiality.

Often it is assumed that the very nature of the research inquiry can pose
risk of harm to subjects. For instance, when reviewing research plans that
involve asking subjects questions about trauma or abuse, IRB members
may be concerned about re-traumatization. However, current research
findings indicate that when appropriate protections are built into the
study design, such as ensuring that interviewers are trained to ask
questions in a supportive, respectful manner and respond to subjects'
reactions appropriately, very few subjects were upset. In fact, most
subjects, including those who may have experienced fleeting negative
emotions, reported feeling good about taking part in the study (Cromer
and Newman 2011). Thus, it is important to review the literature in a given
field to determine what, if any, risk of harm the research topic or design
might pose to the participant and what additional protections may be
necessary.

Assessing Risk

Probability and Magnitude of Harm

When assessing risks of harm associated with participation in a research
study, there are two distinct elements of risk that must be considered.
One is the probability of harm - the likelihood that a specific harm might
occur. The fact that not all possible harms are equally probable should be
taken into consideration when assessing risk. The second element of risk
is the magnitude or severity of harm should it occur. The interaction
between these two elements is a crucial factor in determining the level of
risk of harm in a study.

Often there is disparity between the probability and the magnitude of risk
of harm in a study. For example, a researcher wants to do a web-based
survey of college students to collect information about their sexual
behavior and drug use. Direct identifiers will not be collected; however,
Internet Protocol (IP) addresses may be present in the data set. Although
the probability that an individual subject could be identified is low, the
magnitude of the possible risk of harm is high given the sensitivity of the
information.

Situation and Time

Risks of harm in research participation are specific to time, situation, and
culture. What may be a socially sensitive issue or topic at one time or
place may not be so at another time or place. For example, asking women
if they have had an abortion would carry very different risks in a country
where abortion is a routine medical practice, a country where it is illegal,
or a country in which it is legal but the issue is fraught with religious and
political controversy.

Subject Population
Risks of harm will differ according to the subject population, too. Consider
this case: A study on the efficacy of a behavioral intervention for smoking
cessation involves both adults and teenagers. Purchasing tobacco
products is generally illegal for persons under 18 years of age. For adults,
however, it is a health hazard, but not an illegal activity. Thus, any
assessment of the risk for teenagers will have to consider that the
research focuses on an illegal activity.

Similarly, a survey about sexually transmitted diseases may carry different

risks for different subject populations.

Assessing Risk Objectively

It may be challenging for researchers or potential subjects to assess risk
objectively.

Researchers
People, including researchers, may underestimate risks involved in
activities with which they are familiar and overestimate the benefit of
things that are important to them.
 Potential Subjects
Regardless of the true probability of harm, research indicates that when
potential harms are severe, people tend to overestimate the probability.
When potential harms are less severe, such as embarrassment, people
tend to underestimate the probability.

An independent assessment of risk is critical. One function of IRBs is to

provide this independent assessment.

Balancing Risks and Potential Benefits

Federal regulations, based on the ethical principle of beneficence, require
that risks of harm associated with research are reasonable in relation to
the potential benefits (Protection of Human Subjects 2018).

A great deal of research in the social and behavioral sciences offers little
potential for direct benefits to the subjects themselves. The benefits of the
research often lie in the importance of the knowledge to be gained, the
contributions it makes to science, or the contributions to society in
general. There also might be cases in which a specific community, rather
than individual subjects, benefits from the research. This should be
balanced with the fact that most research in the social and behavioral
sciences poses little or no risk of harm to the individual subject.
In addition, regulations stipulate that risks of harm must be minimized to
the extent possible, consistent with sound research design (Protection of
Human Subjects 2018).

In order to minimize risk, potential research subjects need to be given

sufficient information to make a decision about whether they are willing to
accept risks and participate in the research. If research questions will be of
a sensitive nature, subjects need to be forewarned. Subjects also need to
know what steps will be taken to protect confidential information,
including disposition of recorded material. Any limits to the extent to
which a researcher can protect identifiable personal information should
be clearly explained. State and local laws may limit confidentiality, such as
reporting requirements for child and elder abuse. Confidentiality cannot
be guaranteed for information shared in a focus group.

Minimizing and Managing Risk

It is important to minimize and manage the risks of harm in the research
study. Researchers and IRBs should assess the potential risks of harm in
the study to determine the best minimization and management plan.

When the Primary Source of Risk Is the Data

When a possible disclosure of subject
responses is the primary source of
potential harm, collecting data
anonymously may provide the best
protection. For example, a mailed survey
can be constructed without a follow up
procedure, thereby negating the need for
identifiers.

If, however, the study design makes the collection of identifiers necessary,
for example a longitudinal study, safeguarding the data from
unauthorized access can be accomplished in various ways, including:

 Use of as few direct identifiers as practical.

  Remove all direct identifiers as soon as possible.
 Substitute codes for identifiers.
 Maintain code lists and data files in separate secure locations.
 Use accepted methods to protect against indirect identification, such
as aggregate reporting or pseudonyms.
 Use and protect computer passwords.
 Encrypt transmitted and stored data.
 Access and store data on computers without internet connections.
 Minimize procedures involving transferring direct identifiers
between persons.
 Obtain a Certificate of Confidentiality.
In the past, when data were usually recorded and stored on paper and/or
devices such as floppy disks, researchers restricted access to data by
storing the records in locked file cabinets, in locked offices. With
increasing use of digital technologies to acquire, transmit, analyze, and
store data, data security has become much more complex. Researchers
are not often information technology (IT) experts. Therefore, research
teams should consult with their institutional IT security contacts for
guidance regarding the most secure means of obtaining, transferring,
analyzing, and storing data when the primary source of risk stems from a
security breach.

Certificates of Confidentiality
Another safeguard to protect the privacy of research subjects is a
Certificate of Confidentiality. These certificates are issued by the National
Institutes of Health (NIH) to protect identifiable research information from
compelled disclosure.

A Certificate of Confidentiality prohibits the investigator and others who

have access to the research records covered by the certificate, from
disclosing identifying information on research participants in: civil,
criminal, administrative, legislative, or other proceedings, whether at the
federal, state, or local level (NIH 2021).

Key points include:

  Certificates of Confidentiality protections are permanent and do not
expire.
 Certificates of Confidentiality do not override the requirement to
report the suspicion of child abuse or neglect, or other applicable
federal, state, or local law mandating reporting, such as reporting of
communicable disease or elder abuse.
 Researchers must inform participants about the protections and
limitations to the protections with a Certificate of Confidentiality.
Other federal agencies, such as the U.S. Department of Justice, provide
agency-specific protections that apply to research conducted or funded by
the agency.

When the Primary Source of Risk Is the Consent Document

Subjects may be placed at risk if others
know they are taking part in a study of a
stigmatizing or illegal activity. If the consent
form is the only document that links the
participants to the study, one way to
diminish their risk of exposure is to
consider applying to the IRB for a waiver of
the requirement to document consent. A
waiver of documentation of consent does
not imply that any of the required
elements of consent are waived. The
elements of consent must be provided in some fashion such as in a cover
letter, informational sheet, or verbal script.

Summary
Common social and behavioral sciences methodologies such as surveys,
questionnaires, and interviews are considered (sometimes erroneously)
low risk, because they do not involve physically invasive procedures with
associated risk of physical harm. However, it is not the procedures per
se that engender potential risks of harm, but the interaction of different
factors. It is necessary to assess both the probability and magnitude of
harm, as well as the context (situation, place, and time) of the research as
it relates to the particular study population.
Informed Consent – SBE

Introduction

There is general consensus on the importance of informed consent in

research. Most people have the expectation that they will be treated with
respect and as autonomous individuals. They also expect that they have
the right to make decisions about what will and will not be done to them
and about what personal information they will share with others.

However, researchers also are aware that there are circumstances in

which obtaining and documenting consent in social and behavioral
research may be a complex, and often challenging, process. For instance,
potential subjects may be fluent in a language but not literate.
Researchers may need to deceive research subjects in order to obtain
scientifically valid data. Asking subjects to sign consent forms linking them
to a study about illegal activities could put them at risk of harm.

The federal regulations (at 45 CFR 46, Subpart A) provide sufficient

flexibility to address some of these concerns, particularly for research
posing no more than minimal risk of harm. For example, the regulations
allow waivers of and alterations in the requirements for the consent and
documentation processes.

Learning Objectives

By the end of this module, you should be able to:

 Distinguish between consent as a process and the documentation of

consent.
 Recognize the elements of consent.
 Determine when waivers are appropriate.
 Identify methods for ensuring comprehension of consent.
Key Terms

 Broad Consent is prospective consent for unspecified future

research using identifiable private information or identifiable
biospecimens.
 Key Information is the concise and focused information presented
at the beginning of a consent discussion that is most likely to assist
an individual in understanding the reasons why or why not to
participate in the study.
 Legally Authorized Representative (LAR) means an individual or
judicial or other body authorized under applicable law to consent on
behalf of a prospective subject to the subject’s participation in the
procedure(s) involved in the research. If there is no applicable law
addressing this issue, LAR means an individual recognized by
institutional policy as acceptable for providing consent in the non-
research context on behalf of the prospective subject to the
subject’s participation in the procedure(s) involved in the research
(Protection of Human Subjects 2018).
 Vulnerable means subjects in research studies vulnerable to the
possibility of coercion or undue influence.

Overview of Informed Consent

Federal regulations require researchers to obtain legally effective

informed consent from the subject or the subject's LAR (Protection of
Human Subjects 2018). There are two parts to informed consent.
Consent should begin with a concise and focused presentation of the key
information that is most likely to assist a subject in understanding the
research, what is expected of them, and the potential risks of harm and
benefits.

Regulations require that this information be understandable to the

subject and presented in a way that facilitates comprehension (Protection
of Human Subjects 2018). The emphasis is on presenting information that
a “reasonable person” would want to have in order to make an informed
decision to participate, providing an opportunity to discuss, and ensuring
subject (or LAR) comprehension.

In practice, informed consent forms often are used as a means to provide

information about a study, and, when signed, serve as documentation of
consent.

However, in some cases, an oral consent process without documentation

may be approved by an Institutional Review Board (IRB). The regulation
does allow the exchange of consent information to take place face-to-face
or by mail, telephone, internet (online), fax, or video. An electronic format
for the consent and signatures is also allowed.

Proper Use of Key Information

The key information provided at the beginning of the informed consent
may not contain all the information a potential subject needs to make a
decision to participate.

In the following video, we explore proper use of key information.

Click on the arrow to play the video.

The Process
Informed consent is a process that begins
with the recruitment and screening of a
subject and continues throughout the
subject's involvement in the research. It
includes:

 Providing specific information about

the study to subjects in a way that is
understandable to them.
 Answering questions to ensure that subjects understand the
research and their role in it.
 Giving subjects sufficient time to consider their decisions.
 Obtaining the voluntary agreement of subjects to take part in the
study. The agreement is only to enter the study, as subjects may at
any time withdraw, decline to answer specific questions, or
complete specific tasks during the research.

Documentation
Documentation of consent provides a record that the consent process
took place. It generally consists of a consent form signed by the subject or
the subject's LAR. In practice, this document often is used as a tool for
engaging in the consent process. Informed consent may be documented
by other means, such as audio or video recording, as approved by an IRB.

Information That Must Be Provided to Subjects

Federal regulations at 45 CFR 46 (Protection of Human Subjects 2018) list
specific elements of information that must be provided to subjects about
informed consent. The elements are divided into two categories.

 The first includes basic elements to be provided to subjects.

 The second lists elements that must be included if appropriate.
The two lists are provided below with comments.

Basic Elements
The basic elements of informed consent list nine items that must be
included, as noted in the regulations at 46.116(b). When appropriate, an
analysis or commentary regarding the regulatory element is included in
italics.

46.116(b)(1)
A statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subject's
participation, a description of the procedures to be followed, and
identification of any procedures that are experimental.

46.116(b)(2)
A description of any reasonably foreseeable risks or discomforts to the
subject.

46.116(b)(3)
A description of any benefits to the subject or to others that may
reasonably be expected from the research.

If there are no direct benefits, the researchers may tell subjects what they hope to
learn, how that knowledge will contribute to the field of study or how the knowledge
might benefit others if such a case can be made.

46.116(b)(4)
A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject.
This requirement is primarily relevant for biomedical research. However, it might be
applicable to social and behavioral research if behavioral interventions, such as
novel teaching or therapeutic methods, are proposed.

46.116(b)(5)
A statement describing the extent, if any, to which confidentiality of
records identifying the subject will be maintained.

The description must include a full disclosure of any state-mandated reporting

requirements, such as suspicion of child abuse and/or neglect or harm to others.
State requirements vary, so IRBs and researchers must be aware of state-specific
information.

46.116(b)(6)
For research involving more than minimal risk, an explanation as to
whether any medical treatments are available if injury occurs and, if so,
what they consist of, what compensation will be provided, and where
further information may be obtained.

46.116(b)(7)
An explanation of whom to contact for answers to pertinent questions
about the research and research subjects' rights, and whom to contact in
the event of a research-related injury to the subject.

In some field research, there may not be any way for subjects to call or email anyone
about their questions and concerns. Alternative means of communication must be
established, such as a local contact on the research team.
 46.116(b)(8)
A statement that participation is voluntary, refusal to participate will
involve no penalty or loss of benefits to which the subject is otherwise
entitled, and the subject may discontinue participation at any time without
penalty or loss of benefits to which the subject is otherwise entitled.

Most researchers in the social and behavioral sciences are not in a position to
impose penalties. However, specific study-related assurances that there will be no
negative consequences associated with choosing not to take part might be
appropriate. For example, parents may need to be assured that if they choose not to
participate in a school-based, school-approved study their children's grades or
placement will not be affected.

46.116(b)(9)
One of the following statements about any research that involves the
collection of identifiable private information or identifiable biospecimens:

i. A statement that identifiers might be removed from the identifiable

private information or identifiable biospecimens and that, after such
removal, the information or biospecimens could be used for future
research studies or distributed to another investigator for future
research studies without additional informed consent from the
subject or the legally authorized representative, if this might be a
possibility; or
ii. A statement that the subject's information or biospecimens
collected as part of the research, even if identifiers are removed, will
not be used or distributed for future research studies.

The requirement does not apply to all research; only research that involves the
collection of identifiable information or biospecimens. Research not involving the
collection of information or biospecimens would not require this statement.
 Limits on Confidentiality
Although the research may contain additional safeguards and protections
to limit the potential breach of confidentiality, researchers should still
inform subjects that this risk of harm will still exist. Especially in SBE
research when researchers may collect sensitive or personal information,
they should disclose this potential risk to subjects during the consent
discussion.

The following video illustrates a researcher discussing the limits on

confidentiality with a potential subject.

Click on the arrow to play the video.

Additional Elements (46.116[c])

Depending upon the nature of the research
and the risks involved, there may be
additional required elements, as noted in
the regulations at 46.116(c). These
additional elements are only required
when applicable, so not all consent forms
or discussions would include them. When
appropriate, an analysis or commentary
regarding the regulatory element is
included in italics.

46.116(c)(1)
A statement that the particular treatment or procedure may involve risks
to the subject (or the embryo or fetus, if the subject is or may become
pregnant) that are currently unforeseeable.
 46.116(c)(2)
Anticipated circumstances under which the subject's participation may be
terminated by the investigator without regard to the subject's or the
legally authorized representative’s consent.

46.116(c)(3)
Any additional costs to the subject that may result from participation in
the research.

46.116(c)(4)
The consequences of a subject's decision to withdraw from the research
and procedures for orderly termination of participation by the subject.

Subjects need to know, for example, how their compensation will be affected if they
choose not to complete an interview. Discussion of what happens to data already
collected if they withdraw midway through the study also may be addressed in this
section.

46.116(c)(5)
A statement that significant new findings developed during the course of
the research that may relate to the subject's willingness to continue
participation will be provided to the subject.

This requirement applies primarily to biomedical research involving new treatments

and procedures, but also may apply to research on experimental behavioral
interventions.

46.116(c)(6)
The approximate number of subjects involved in the study.
 46.116(c)(7)
A statement that the subject’s biospecimens (even if identifiers are
removed) may be used for commercial profit and whether the subject will
or will not share in this commercial profit.

46.116(c)(8)
A statement regarding whether clinically relevant research results,
including individual research results, will be disclosed to subjects, and if
so, under what conditions.

46.116(c)(9)
For research involving biospecimens, whether the research will (if known)
or might include whole genome sequencing (i.e., sequencing of a human
germline or somatic specimen with the intent to generate the genome or
exome sequence of that specimen).

Incentives
Incentives are payments or gifts offered to subjects as reimbursement for
their participation. These must be described during the consent process
as well as the conditions under which subjects will receive partial or no
payment.

Recruitment
Recruitment is part of the consent process because it begins the process
of providing information about the study. All recruitment strategies such
as fliers, email messages, newspaper advertisements, phone scripts, and
so on must be reviewed and approved by an IRB before they are used.

In the following video, researchers discuss considerations for developing

recruitment materials and potential pitfalls.

Click on the arrow to play the video.

 Exculpatory Language
Subjects may not be asked to waive or even appear to waive any of their
legal rights. They may not be asked to release a researcher, sponsor, or
institution from liability for negligence. Institutions may provide
information about how liabilities will be covered.

Broad Consent (46.116[d])

Broad consent, as noted in the regulations at 46.116(d), is an optional

alternative process of obtaining consent for the storage, maintenance,
and secondary research use of identifiable private information and
identifiable biospecimens (Protection of Human Subjects 2018).
Researchers should consult with their institution and IRB policies as broad
consent may not be implemented at all places.

Read more about broad consent…

Ensuring Comprehension of Consent Information

Researchers are required to provide information in a manner

understandable to the subjects. The regulations emphasize that consent
must begin with a “concise and focused presentation” to the subject and
provide information that would help the subject determine whether to
participate (Protection of Human Subjects 2018).

Effective informed consent includes providing sufficient detail about the

research and presenting information in a way that is not just a list of facts.
This requires preparing material in the subject's language at the
appropriate reading level. When a study is complex and/or the reading or
educational level of the prospective study population is low, the role of
dialog and explanation becomes an even more crucial part of the consent
process.

Ensuring Free Choice

The principle of respect for persons requires that participation in research

be truly voluntary and free from coercion or undue influence. Even when a
study is innocuous, subjects must be informed that they do not have to
take part, and they may choose to stop participating at any time.

Setting and Time

Researchers should consider ways in which
the setting of the consent process might
include elements of undue influence.
Potential subjects might not feel entirely
free to choose whether to take part in a
research study if they are:

 Adolescents whose parents are in the

room
 Adolescents in a group of other
adolescents being recruited for the same study
 Parents who receive a letter from the school principal asking them
for permission to enroll their children in a study
  Athletes recruited by their coach
 Employees asked to take part by their employer
Subjects must be given adequate time to consider whether they wish to
take part in a study. This is particularly true if the study procedures involve
more than minimal risk or will require subjects to disclose sensitive
information.

Compensation or incentives to participate may not be so high that they

override other considerations for potential subjects. Determining whether
incentives are unduly influential depends on the research context and the
financial and emotional resources of the subjects.

Safeguards for Vulnerable Subjects During Consent

Federal regulations state that IRBs must ensure that appropriate
safeguards are in place to protect the rights and welfare of subjects likely
to be vulnerable to coercion or undue influence. Potentially vulnerable
subjects include children, prisoners, individuals with impaired decision-
making capacity, or economically or educationally disadvantaged persons.
Additional safeguards for three groups are provided in the regulations:

 Subpart B for pregnant women, human fetuses, and neonates

involved in research
 Subpart C for research involving prisoners as subjects
 Subpart D for children involved as subjects in research
Safeguards employed for vulnerable subjects include, among many other
strategies, assessing the decision-making capacity of potential subjects,
requiring parental permission from both parents rather than just one
parent for some studies with children, and ensuring that incentives are
not coercive.
Informed Consent in Exempt Research

If an institution determines that a study meets the criteria for exempt

research, the detailed regulatory requirements for informed consent in 45
CFR 46.116 do not apply.

However, research that is exempt from federal regulations is still research

with human subjects and the ethical principles as outlined in the Belmont
Report still apply. Each institution or IRB decides how to handle informed
consent in research that is eligible for exemption from the regulations.

Under the 2018 Requirements version of the Common Rule, some exempt
research requires a limited IRB review (administrative review). In two of
the exempt categories, limited IRB review is required to ensure there are
adequate confidentiality and privacy safeguards. In the other two
categories, limited IRB review is required for broad consent in studies
involving identifiable private information or identifiable biospecimens.

Remember, if an individual was asked to provide broad consent and

refused, an IRB cannot waive consent for the storage, maintenance, or
secondary research use of the identifiable private information or
identifiable biospecimens.

Waivers of the Elements of Consent

The federal regulations at 46.116(f) allow IRBs to authorize researchers to

modify the consent process by omitting one or more elements of
information or to provide no information at all. The waiver or alteration of
any or all of the elements of consent can be authorized only if these five
criteria are met.

Regulatory Criteria Explanation

The research involves no Minimal risk means

more than minimal risk "the probability and
to the subjects. magnitude of harm or
discomfort anticipated
 in the research are not
greater in and of
themselves than those
ordinarily encountered
in the daily life or
during the
performance of routine
physical or
psychological
examinations or tests"
(Protection of Human
Subjects 2018).

The research could not Impracticable does not

practicably be carried out mean time consuming,
without the requested expensive, or
waiver or alteration. inconvenient. It means
that securing consent is
not feasible, regardless
of cost and time.

Impracticable may
mean that without a
waiver it would not be
possible to answer the
research question.
Disclosing the purpose
of the research may
influence how subjects
respond.

If the research involves Identifiable private

using identifiable private information is private
information or information for which
identifiable the identity of the
biospecimens, the subject is or may
research could not readily be ascertained
practicably be carried out by the investigator or
without using such associated with the
information or information.
biospecimens in an
identifiable format. An identifiable
biospecimen is a
biospecimen for which
the identity of the
subject is or may
readily be ascertained
by the investigator or
associated with the
biospecimen.

The waiver or alteration In the absence of

will not adversely affect specific legal rights, this
the rights and welfare of criterion is often
the subjects. difficult to apply
because the federal
regulations do not
define "rights and
welfare."

Also, the parties

involved in the
research process
(researchers, IRBs, and
the community of
subjects) may not
always agree on how to
define subjects' rights
and welfare.

When a waiver is
required because the
 research involves
deception, this
requirement usually is
interpreted to mean
that subjects are not
"tricked" into
participating in a study
that they would find
objectionable.

Whenever appropriate, This process often is

the subjects or legally referred to as
authorized debriefing. The
representatives will be debriefing process is
provided with additional an opportunity to
pertinent information provide subjects with
after participation. information not
disclosed during the
initial consent process.
It also provides an
opportunity for
subjects to withdraw
and not have their
identifiable data
included in the
research.

Note: Debriefing is not

required in situations
in which debriefing
would cause more
harm than good, for
example, if subject
selection was based on
an undesirable or
unflattering
 characteristic.

Note: As noted in the regulations, broad consent has additional

requirements and limitations.

Waiver for Screening, Recruiting, or Determining

Eligibility
Under 46.116(g), the IRB may also approve a research study when the
investigator will obtain information or biospecimens for purposes of
screening, recruiting, or determining eligibility for the study without the
informed consent of the prospective subject or the subject’s legally
authorized representative, if either of the following conditions are met:

1. The investigator will obtain information through oral or written

communication with the prospective subject or legally authorized
representative.
2. The investigator will obtain identifiable private information or
identifiable biospecimens by accessing records or stored identifiable
biospecimens.

Examples of When Partial and Complete Waivers Would

Be Used in Deception and Complete Non-Disclosure
In social and behavioral research, deception and complete non-disclosure
of information to subjects may be necessary to avoid subject response
bias in the research. The IRB must review the research plan for deception
or complete non-disclosure of information to ensure there is adequate
justification for the technique as well as an adequate debriefing plan for
after the research.

Deception
Outright deception can sometimes be justified as essential for
investigating a particular phenomenon. For example, subjects may be told
that a study is about perception of visual phenomenon, when in fact it is
about susceptibility to peer pressure from the researcher's confederates.

Complete Non-Disclosure
If people know that they are being observed, they may alter their behavior
in such a way that obtaining meaningful results is not possible. Covert
observation requires a waiver of all of the elements of consent if the
research takes place in a setting in which subjects could reasonably expect
that their behavior was not being observed and recorded.

Waivers of Parental Permission and Child Assent

An IRB may waive the requirement to secure parental permission for
children to take part in research, in accordance with the same criteria for
waiving consent.

The regulations do not include a list of elements that must be included in

a child assent process. It is up to an IRB to determine whether child assent
is required, what elements must be included in the assent process, and
whether the assent must be documented.

Documentation of Informed Consent

When documentation of informed consent is required, there are two

methods available:

1. The subject or the subject's legally authorized representative signs a

form (by hand or electronically) containing all the required elements
of consent and any additional information necessary to provide
complete disclosure. The person who signed the consent form is
given a copy as a reference and reminder of the information
conveyed.
2. The consent is done orally in language understandable to the
subject and is documented by an impartial witness. This process
uses two documents: (1) a short form written consent document
stating that the required elements of consent have been presented
orally to the subject or the subject's legally authorized
 representative, and (2) a written, IRB-approved summary of what
will be said to the subject or the subject's representative. The
subject signs the short form. The witness signs both forms. The
person actually obtaining consent signs the summary. Copies of the
short form and the summary are given to the subject.
Note: English-speaking subjects who have low literacy (nonreaders) can
"make their mark" on the informed consent document, as long as it is
consistent with applicable state or local laws.

Waivers of Documentation

Documentation of the consent process is not always required. Note,

however, that waivers of documentation are not waivers of the consent
process itself. For waivers of consent, see the criteria noted earlier.

Under the federal regulations at 46.117(c)(1), an IRB may waive

documentation under three circumstances (Protection of Human Subjects
2018):

1. The principal risks are those associated with a breach of

confidentiality concerning the subject's participation in the research,
and the consent document is the only record linking the subject with
the research. For example:
 Research about women who have left abusive partners.
 Research on the black market in Cuba in which illicit vendors
will be interviewed in a safe space.
When the requirement for documentation is waived, the IRB may
require the researcher to offer the subjects information about the
study in writing.

2. Study participation presents minimal risk of harm to the subject and

the research involves no procedures requiring consent outside the
context of participation in a research study, for example, a
telephone survey.
3. Subjects or legally authorized representatives are members of a
distinct cultural group or community in which signing forms is not
the norm, the research presents no more than minimal risk of harm
 to subjects, and provided there is an appropriate alternative
mechanism for documenting that informed consent was obtained.

Summary

Informed consent includes both the process of sharing information and

documenting that the process took place. To ensure that potential
subjects can truly make informed decisions about whether to take part in
research, issues of comprehension, language, and culture need to be
considered in addition to the elements of information provided in the
regulations. The regulations provide criteria for waiving any or all of the
elements of information and the documentation of consent.
Privacy and Confidentiality – SBE

Introduction
The Common Rule (45 CFR 46, Subpart A) states that when reviewing
research proposals, Institutional Review Boards (IRBs) must determine
that there are adequate provisions for protecting the privacy of subjects
and maintaining the confidentiality of data.

The Common Rule is just one document that directs researchers to

consider privacy and confidentiality when conducting research. The
guidelines of the American Anthropological Association, the Oral History
Association, the American Psychological Association, and the American
Sociological Association, identify protecting privacy and ensuring
confidentiality as key components of respecting the safety and dignity of
research subjects.

This module will define "privacy" and "confidentiality." It also will discuss
some research methods and topics that raise concerns about privacy,
identify some standard methods for providing confidentiality, and discuss
relevant laws, other than the Common Rule.

Learning Objectives

By the end of this module you should be able to:

 Distinguish between privacy and confidentiality.

 Identify privacy risks associated with study designs.
 Identify a range of procedures for ensuring confidentiality.
 Identify relevant laws regarding the collection of private information.
 Identify laws that limit the ability to ensure confidentiality.

Definitions
The IRB Guidebook (OHRP 1993) defines privacy and confidentiality.
Although privacy and confidentiality are closely related, they are not
identical. Privacy is related to methods of gathering information from
research subjects; confidentiality refers to the obligations of researchers
and institutions to appropriately protect the information disclosed to
them.

Confidentiality procedures, as described during the informed consent

process, allow subjects to decide what measure of control over their
personal information they are willing to relinquish to researchers.

It is not always the case that identifiable information provided by research

subjects must be protected from disclosure. Some subjects want to be
identified and quoted. Some agree to have their photographs, audio, or
video recordings published or otherwise made available to the public.

Identifying Private Information

Federal regulations (Protection of Human Subjects
2018) define private information to mean
"information about behavior that occurs in a context in
which an individual can reasonably expect that no
observation or recording is taking place, and
information that has been provided for specific
purposes by an individual and that the individual can
reasonably expect will not be made public (e.g., a
medical record)."
Applying the reasonable assumption standard is not a simple task. It
would be unreasonable to assume that behavior on a street corner or a
public park is private, but reasonable to assume that behavior in our
homes is private. However, given that technology makes it possible to film
and record conversations from considerable distances, a third kind of
space may be emerging: private spaces in the midst of very public ones.
Parents taking their children to a city park might justifiably consider it a
violation of privacy if the interactions of their children were audiotaped
using long-range recording devices.

Reasonable assumptions regarding privacy will vary from culture to

culture and setting to setting. For example, in some cultures, health
information is considered very private, but in others, information about
people's health is part of the community dialogue and widely shared.

Reasonable assumptions about privacy may vary among generations. The

legal maxim that privacy is the "right to be let alone" (Warren and
Brandeis 1890) comes from a world where privacy was seen as threatened
by, among other things, the technologies that allowed still photographs to
appear in mass-circulated newspapers. Now, through social media, people
use images to document their behavior and that of their friends and
family, sometimes without restricting public access to the images. It may
be difficult to discern if and when people feel their use of the Internet is
public or private.
Controlling Access to Private Information
Individuals' ability to control access to their bodies and to their personal
information is determined by a variety of factors, including socioeconomic
status, age, and circumstance.

For example, information about birth records is public information while

information about personal stock portfolios is not. Children have different
rights to privacy than adults. Institutionalized persons may have significant
limitations on their ability to control personal information.

Privacy and Research Methods

While not an exhaustive list, the following material highlights some
concerns about privacy in the context of research:

 Observational Studies
 Focus Groups
 Snowball Sampling

Observational Studies
In some observational studies, researchers
participate in the activities being observed
and the subjects know that the researchers
have dual roles as both participants and as
researchers. However, if subjects are
observed and private identifiable
information is gathered about them
without their knowledge and consent,
there is a clear violation of their right to
privacy.

Determining whether covert observation can be considered ethically

sound depends on answers to questions such as whether the invasion of
privacy is justified by the potential benefit of the study and what, if
anything, the subjects will be told after the data are collected. For
example, a researcher interested in the effects of subliminal priming on
the choice between healthy or unhealthy snacks made available to
subjects during a "break" between study tasks, may videotape the subjects
during the break without their knowledge. Can the researcher articulate a
potential benefit? Should the subjects be given the opportunity to ask that
the film of their behavior be destroyed?

Focus Groups

It is not possible for a researcher to promise

confidentiality in a focus group setting."

Focus groups are unique settings in which both privacy and confidentiality
may be issues. In effect, focus group participants relinquish control of the
extent, timing, and circumstances of sharing themselves because other
group members may repeat what they say outside the group. This may
occur even if researchers emphasize that comments made during the
focus group session should not be repeated. Researchers may protect
recordings and transcripts themselves, but they have no authority to enlist
participants in agreements to appropriately protect the information
shared. Researchers can encourage participants to be as honest and open
as they can, but when the topic warrants, also should encourage them to
remain mindful of the limits on the researcher's ability to protect their
privacy.

Snowball Sampling
Snowball sampling is a recruitment technique in which research
participants are asked to assist researchers in identifying other potential
subjects. If the topic of the research is not sensitive or personal, it may be
appropriate for subjects to provide researchers with names of people who
might be interested in participation. If the topic is sensitive or personal,
such as the fact that someone was adopted, considerable care should be
taken so that potential subjects' privacy is not violated. In this case,
subjects assisting with recruiting could provide information about the
research to potential subjects, rather than giving the researcher names of
potential subjects.
Privacy and Study Questions
Invasions of privacy can occur if subjects are asked questions that they
find intrusive. If a survey instrument or an interview script contains
questions that individuals are likely to find intrusive, they must be
informed about the nature of the questions in advance.

Studies about possible topics that are of a sensitive nature should include
a disclosure in the consent form about the sensitive nature of the
questions. The survey instrument or interview process must be designed
so that subjects may choose not to answer any question that makes them
uncomfortable, or that they want to skip for any reason.

Cultural standards should be taken into account when designing research.

Topics that are considered appropriate in one setting may be offensive
and off-limits in another.

Protecting Communications with Subjects

If a study is obviously about stigmatizing conditions, illegal activities, or life
experiences that subjects may not want others to know about,
communications with the subjects should not reveal their participation in
the study to others. To do so would violate the subjects' right to privacy.
Study titles should be carefully considered; it is often best if the title does
not reveal sensitive information about subjects. A method of
communication that is of particular concern is email. Employee email is
not secure and some personal accounts may be accessed by anyone in
the family. Telephone calls to subjects at home may be of concern. It may
be appropriate to script calls carefully so that no information is revealed
about the caller or the subject to anyone other than the subject. In some
cases, it may be appropriate to remind subjects to prevent possible
violations of their privacy in their homes by, for example, closing browsers
after completing an online survey on a sensitive topic.

Confidentiality
Researchers provide confidentiality to their subjects by appropriately
protecting information the subjects disclose. The potential risk of harm to
subjects if identifiable data were inadvertently disclosed is the key factor
for determining what kinds of protection are needed.

The ideal way to protect research data is not to collect information that
could identify subjects. Collection of direct identifiers, such as names or
email addresses, or indirect identifiers, such as information that could be
used to deduce subjects' identities, should be avoided.

The only way to render data entirely anonymous is to remove all

identifying information from the data and completely disconnect any links
between the subjects and data about the subjects.

If researchers plan to retain individually identifiable data that could place

participants at risk of harm if inadvertently disclosed, researchers need to
design procedures to protect the data during collection, storage, analysis,
and reporting. These procedures could include creating keys linking
subjects' names to unique numbers associated with the data, storing
encrypted data on secure servers, removing identifiers when data
collection is completed, reporting data in aggregate, and creating
misleading identifiers in articles or presentations.

Consent forms should clearly explain who will have access to identifiable
data, both in the present and in the future, and describe any future uses
of the data. The consent forms must also contain a statement describing
the extent, if any, to which confidentiality of records identifying the subject
will be maintained. Also, federal regulations require that researchers must
include one of the following statements on the consent form (Protection
of Human Subjects 2018):

a. A statement that identifiers will be removed from the identifiable

private information and that after the data are de-identified they
could be used for future research studies or distributed to another
researcher; or
b. A statement that the subject’s information collected as part of the
research, even if identifiers are removed, will not be used or
distributed for future research studies.
For example, if researchers want to show video clips of research subjects
during conference presentations or use them in a classroom, the subjects
must be asked for permission to use their images in those ways.

Privacy and Reporting Laws

Under the Common Rule, the IRB is tasked with assessing whether the
study plan has adequate provisions to protect the privacy of subjects and
to maintain the confidentiality of data (Protection of Human Subjects
2018). However, there are other regulations and laws that also address
privacy and confidentiality in research.

Federal Privacy Laws

The Family Educational Rights and Privacy Act (FERPA) protects the
disclosure of educational records, while the Health Insurance Portability
and Accountability Act (HIPAA) protects against the dissemination of
private health information.

Generally, under FERPA, the disclosure of these records to researchers

involves securing written authorizations from the potential subjects
(students or their parents), although in certain clearly defined
circumstances, the requirement to secure authorizations may be waived.

Researchers in the social and behavioral sciences, as well as the

humanities, usually do not generate private health information covered by
HIPAA. Rather, they ask for it to be disclosed to them, usually by asking
subjects to sign authorizations permitting the disclosure. Most institutions
covered by HIPAA have models of authorization forms that they expect
researchers to use.

State Reporting Requirements

State reporting laws may limit the promises of confidentiality that
researchers can offer subjects. State reporting laws may cover such
matters as specific communicable diseases, the intent to harm oneself or
others, and elder abuse. Most state laws identify individuals who must
report suspected child abuse and neglect. This requirement should be
described when child abuse and neglect might be revealed in a research
study. Such studies could involve at-risk youth, school-based
interventions, or parenting practices, among others.

On the other hand, there are many studies in which it is extremely unlikely
that the topic would arise or that the researcher would be in a position to
observe neglect or abuse. For example, a study of decision-making
strategies using computer-based activities would not generate
information about child abuse, and there would be no need to discuss
reporting requirements during the consent process.

Researchers should consult with the reviewing IRB about the laws in the
state or local area where the research will occur.
 International Privacy Laws
Researchers conducting research abroad should identify privacy laws at
the research site that may be relevant for the conduct of research with
human subjects. Regulations such as the European Union General Data
Protection Regulation (GDPR) may affect research that is conducted in
Europe and even the U.S.

Exempt Research
The Common Rule now includes considerations for privacy and
confidentiality for exempt studies using limited IRB review as a condition
of approval, and there are some cases where an exempt study would
require a consent form. Researchers should be aware that even exempt
studies may need to meet privacy/confidentiality requirements.

Certificates of Confidentiality
Certificates of Confidentiality are issued by the National Institutes of
Health (NIH) (an agency of the U.S. Department of Health and Human
Services [HHS]) to protect identifiable research information from
compelled disclosure.

Certificates of Confidentiality protect all copies of information, documents,

and biospecimens, that are collected or used by the investigator during
the research.

The Certificate of Confidentiality protections also cover copies of

information, documents, and biospecimens that are shared for other
research activities. These protections are permanent and do not expire.
Certificates of Confidentiality do not override the requirement to report
the suspicion of child abuse or neglect, or other applicable federal, State,
or local law mandating reporting, such as reporting of communicable
disease or elder abuse.

Other federal agencies, such as the Department of Justice, provide agency-

specific protections that apply to research conducted or funded by the
agency.

Under the Certificate of Confidentiality policy issued 7 September 2017,

NIH-funded investigators do not need to apply for a Certificate of
Confidentiality, nor will they receive a physical certificate. The NIH issues
Certificates of Confidentiality automatically for “NIH funded grants,
cooperative agreements, contracts and intramural research projects
research funded wholly or in part by the NIH that collects or uses
identifiable, sensitive information” (NIH 2017). Investigators are
responsible for determining whether the NIH-funded research they
conduct is automatically issued a certificate. Investigators must comply
with the Certificates of Confidentiality policy requirements, which include
limited circumstances when the investigator may release a participant’s
identifiable information and informing anyone that receives a copy of the
protected information about the certificate protections and disclosure
restrictions.

Non-NIH funded investigators may apply for a Certificate of Confidentiality

from the NIH or other U.S. Department of Health and Human Services
(HHS) agency that issues Certificates for specific research studies. NIH will
consider requests for Certificates of Confidentiality for specific research
projects that are not funded by NIH. These considerations include if the
research project is collecting or using identifiable, sensitive information, if
the research is on a topic that is within the NIH mission (an agency of the
HHS) or HHS health-related research mission, and if the research
information associated with the project will be collected, used, or stored in
the U.S.

Certificates of Confidentiality protections are the same, regardless of

source of research funding.
Researchers must inform participants about the protections and
limitations to the protections with a Certificate of Confidentiality.

Summary
Although privacy and confidentiality deal with different aspects of a study
design, how these two issues are handled translate into issues of trust and
security for a research participant.
Research with Prisoners – SBE

Introduction
The history of conducting research with prisoners has been problematic.
As a group, prisoners have been a population of convenience; researchers
knew where they were and would be, often for many years. In addition,
prisoners lived under controlled conditions conducive to research. It was
generally accepted to use prisoners as research subjects for testing
medicines, drugs, and medical devices without regard to the risks,
benefits, and rights of those individuals.

As documented in Acres of Skin: Human Experiments at Holmesburg

Prison (Hornblum 1998), prisoners were used in lieu of laboratory animals
to test the toxicity of cosmetics. In other experiments, prisoners were
irradiated in research conducted by the Atomic Energy Commission,
rendering some sterile and others badly burned. These are only two
examples of many experiments using prisoners as subjects.

In 1978, the United States (U.S.) Department of Health, Education, and

Welfare, the predecessor to the U.S. Department of Health and Human
Services (HHS), issued additional regulations providing safeguards for
prisoners as research subjects -- Subpart C: "Additional Protections
Pertaining to Biomedical and Behavioral Research Involving
Prisoners as Subjects." These regulations address the fact that prisoners
are under constraints that could affect their ability to make truly voluntary
and un-coerced decisions to participate in research. Subpart C imposes
strict limits on the involvement of prisoners as research subjects. The only
research that may be conducted with prisoners as subjects is research
that is material to the lives of the prisoners.
Note – the U.S. Department of Justice (which includes the National
Institute of Justice and the Federal Bureau of Prisons and other agencies)
complies with the pre-2018 Requirements of the Common Rule, but is not
a signatory to the 2018 Requirements (the revised Common Rule with a
general compliance date of 21 January 2019). Also, additional
requirements exist for research conducted with the consent of the Bureau
of Prisons (BOP) and each BOP facility may have unique rules and
requirements that researchers should be aware of and comply with. These
are not addressed in this module.

Learning Objectives

By the end of this module, you should be able to:

 Examine and apply the definition of "prisoner" in the federal

regulations.
 List the four categories of permissible research with prisoners
allowed by the federal regulations.
 Identify issues to consider when designing research to be conducted
with prisoners.
 Identify issues related to accessing prison populations.
 Describe the regulatory obligations of an Institutional Review Board
(IRB) reviewing prisoner research.

Defining Prisoner
45 CFR 46.303 (Protection of Human Subjects 2018) defines a prisoner as
follows:
Included in this definition are those individuals in hospitals or alcohol and
drug treatment facilities, who are under court order. Individuals in work-
release and house-arrest programs also qualify as prisoners. Individuals
on parole are not considered prisoners. The definition applies to both
minors and adults.

Defining Minimal Risk for Prisoners

Minimal risk is also defined differently for prisoners.

Non-Prisoner Minimal Risk

46.102(i) (Protection of Human Subjects 2018) defines non-prisoner

minimal risk as “the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than
those ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests.”

Prisoner Minimal Risk

46.303(d) (Protection of Human Subjects 2018) defines prisoner minimal

risk as “the probability and magnitude of physical or psychological harm
that is normally encountered in the daily lives, or in the routine medical,
dental, or psychological examination of healthy persons.”
 Office for Human Research Protections (OHRP) Clarifications

 The Subpart C definition (prisoner minimal risk) refers to physical or

psychological harm rather than harm or discomfort as in the
Subpart A definition (non-prisoner minimal risk).
 The Subpart C definition compares the probability and magnitude of
harm in the research to the probability and magnitude of those
harms normally encountered in daily life, or in routine medical,
dental, or psychological examinations, rather than in daily life or
routine physical or psychological examinations or tests as in Subpart
A.
 The Subpart C definition identifies healthy persons as the
comparison group against which the risks of the research should be
measured, rather than leaving the comparison group unspecified, as
in Subpart A. OHRP interprets the term healthy persons in this
definition as referring to healthy persons who are not prisoners.

Research Allowed Under the Federal Regulations

The regulations at 45 CFR 46.306 (Protection of Human Subjects 2018)
allow prisoners to be involved in four categories of research. Most social
and behavioral sciences research falls into the first two categories:

1. No more than minimal risk research on the possible causes, effects,

and processes of incarceration and of criminal behavior, provided
that there is no more than inconvenience to the subjects.
2. No more than minimal risk research that studies prisons as
institutional structures or of prisoners as incarcerated persons,
provided that there is no more than inconvenience to the subjects.
3. Research on conditions particularly affecting prisoners as a class (for
example, vaccine trials and other research on diseases such as
hepatitis and HIV which are more prevalent in prisons than
elsewhere; and research on social and psychological problems such
as alcoholism, drug addiction, and sexual assaults).
4. Research on practices, both innovative and accepted, which have
the intent and reasonable probability of improving the health or
well-being of the subjects. Studies that require the assignment of
 prisoners to control groups in which they may not benefit from the
research may need federal-level review.
Examples of social and behavioral sciences research in the categories
listed above include:

 Age at first arrest as a predictor of adult criminal history

 Effects of overcrowding on prison populations
 The influence of prison-awarded incentives (such as promotions in
custody level) on retention in substance abuse treatment programs
 The use of true crime/detective stories as bibliotherapy
 Social support systems in prisons
 The functioning of pseudo-families in prison

Designing Prison Research

In designing research that includes prisoners as subjects, it is important to
consider issues such as informed consent and confidentiality.

Consent Issues
Obtaining informed consent from prisoners may be challenging, specific
consent issues include:

Free Choice

Informed consent requires the ability to choose freely, without coercion

and without undue influence. Because the autonomy of prisoners is
necessarily limited, the regulations include provisions designed to reduce
any undue influence on prisoners' decisions to participate in research. For
example, each prisoner must be clearly informed that the decision to take
part in research will have no effect on an inmate's eligibility for parole.
 The Use of Incentives

Incentives to take part in research should be appropriate to the research

setting and subject population. Prison cultures and prison structures are
such that incentives that might seem trivial in the outside world could
carry great significance within a prison.

The presence of incentives in research is not always clear within the prison
culture. As such, the regulations at 45 CFR 46.305 (Protection of Human
Subjects 2018) require the IRB to consider "any possible advantages
accruing to the prisoner through…participation in the research, when
compared to the general living conditions, medical care, quality of food,
amenities and opportunities for earnings" within the prison. The IRB
should determine that these types of incentives do not compromise a
prisoner's ability to make an informed choice.

Here are two examples where incentives may result in undue influence.

Example 1: Photograph as an Incentive

A researcher offered women photographs of themselves and their visiting

children that would be taken and framed by a professional photographer.
In a prison environment, where women are deprived of their children and
do not have cameras, this particular form of compensation might create
pressure to participate, resulting in undue influence.

Example 2: Money as an Incentive

In many states, the maximum daily wage a prisoner may earn is $1.00.
Offering $25.00 for participation in research would be comparable to five
weeks pay and might unduly influence prisoners' decisions about
participating in the research.

Descriptions of Confidentiality

Consent forms need to be written at a level that is understandable to the

subject population. Risks, and measures to minimize these, need to be
explicit and detailed. The consent form should clarify the type of
information available to correctional staff, such as a final report containing
aggregate data but not information that would identify individuals.

Limits to Confidentiality

Researchers need to specify the limits of confidentiality. Consent forms

should clearly state what information can never be confidential within a
prison, such as prisoners' threats to hurt themselves or others, and
professed plans to escape. This kind of information must be reported to
the prison authorities. Researchers need to be aware of the circumstance
in which even having a copy of the consent form may lead to a breach of
confidentiality.

Researchers need to be aware of the circumstance in which the subject

having a copy of the consent form may lead to a breach of confidentiality,
and clearly communicate this risk to subjects. For example, if other
prisoners or staff read the consent form, they may learn that the prisoner
subject has a particular condition or illness, criminal conviction or
information that the subject would have preferred to remain private.

Assessing Risk
There may be additional potential risks of harm in research involving
prisoners.

Harm in Asking Questions

There is often a limited support system within a prison that prisoners can
use to "debrief" following their involvement in research. Prisoners often
have limited means and skills to work through their issues and feelings.
Strategies used to cope with stress that are available outside prison, such
as telephoning a friend or going for a run, may be restricted in the prison
setting. Researchers, in conjunction with prison staff, need to develop
strategies for managing the risks presented when inmates are asked
potentially emotionally charged questions (such as the events leading to
their incarceration, their current emotional health, or about relationships).

Breach of Confidentiality
This section includes examples of potential breaches of confidentiality
unique to the prison setting and some strategies for managing that risk.

Nature of Conviction

Scenario: A researcher is studying child abuse history of pedophiles in

order to develop treatment strategies for use within the prisons. He wants
to call 25 pedophiles out of the general prison population for interviews.

Discussion: There is a great deal of offender information that is freely

available to the public: an inmate's name, age, race, sex, conviction, court
where sentenced, and length of sentence.

However, some of this information, though publicly available in free

society, becomes private within the prison. Within prisons some crimes
are more "acceptable" than others. Given the culture of a prison, the
identification of a research participant as a pedophile may expose that
individual to harm. Even though convictions are public information,
researchers do not have the right to disclose information about a person's
conviction to other prisoners.

A possible strategy for managing this particular risk is to interview 50

people who had committed a variety of crimes so that 25 pedophiles
included among the 50 would not be identified to other prisoners.
 Health Status

Scenario: A researcher is studying quality-of-life issues in inmates who

have a positive HIV status.

Discussion: Prisoners have little privacy and, in many facilities, there is still

stigma attached to a positive HIV status. As in the previous scenario, the
researcher needs to consider study design strategies to keep the subject
matter confidential, perhaps by interviewing prisoners with a range of
health conditions that includes a positive HIV status.

It would be easier to maintain confidentiality when conducting this type of

research outside the prison setting. A researcher could arrange to conduct
the interview in a private setting so that no one but the researcher would
know the subject's health status.

Prison Life

Scenario: A researcher proposes to conduct focus groups with women

prisoners. The goal is to develop an understanding of the kinds of services
incarcerated women will need in order to break the cycle of repeated
arrests.

Discussion: Researchers need to be mindful of the inability to guarantee

confidentiality within focus groups. One possible consequence in this case,
among many, is that a woman might mention something in the focus
group that could be used against her by other group members. It is
difficult to ensure that group members will not talk outside the group;
other inmates or staff may try to persuade members to share information.
The researcher needs to ensure that all members understand this risk. In
the absence of such assurances, it may be preferable for the researcher to
acquire data about needed services through individual interviews.

IRB Review of Prison Research

There are additional requirements under Subpart C for IRBs that review
research involving prisoners.
 Required Composition of the IRB
A majority of the IRB members must have no association with the prison(s)
involved, apart from their membership on the IRB (Protection of Human
Subject 2018).

At least one member of the IRB must be a prisoner or a prisoner

representative with appropriate background and experience to serve in
that capacity. The prisoner representative must be a voting member of the
IRB with a close working knowledge and understanding and appreciation
of prison conditions from the prisoner's perspective. If a research project
is being reviewed by more than one IRB, only one IRB must satisfy this
requirement.

Suitable members that would meet the prisoner or prisoner

representative requirement include:

 Former prisoners
 Prison chaplains
 Prison psychologists
 Prison social workers
 Other prison service providers
 Prisoners' rights advocates
 Other individuals who are qualified to represent the rights and
welfare of prisoners by virtue of appropriate background and
experience with prisons and prisoners
According to OHRP guidance, institutions have the option of stipulating
that the prisoner representative will only count toward a quorum when in
attendance at a convened meeting and reviewing studies covered by
Subpart C.

Required IRB Findings

For research involving prisoners, the IRB must make additional
determinations before approving the research. The IRB must determine
that (Protection of Human Subject 2018):
  The research under review falls into one of the four categories of
permitted research for prisoners.
 Any benefits to the prisoner that may result from being in the
research when compared to the general living conditions, medical
care, quality of food, amenities, and opportunity for earnings in the
prison, do not impair the prisoners' ability to weigh the risks of the
research against the benefits in the prison environment.
 The risks involved in the research are commensurate with risks that
would be accepted by non-prisoner volunteers.
 Procedures for the selection of subjects within the prison are fair to
all prisoners. Control subjects must be selected randomly from the
group of available prisoners who meet the characteristics needed
for that particular research project.
 The study information is presented in language that is
understandable to the subject population.
 Prisoners have been clearly informed in advance that participation
in the research will have no effect on their eligibility for parole.
 Adequate provisions have been made for follow-up examination or
care, and prisoners are informed that the provisions have been
made.

Exempt and Expedited Review of Prisoner Research

Exempt research under 45 CFR 46.104 (Protection of Human Subjects
2018) may include prisoners if the research is aimed at involving a broader
subject population and only incidentally includes prisoners.

Although the federal regulations permit expedited review of prisoner

research, OHRP strongly discourages the use of expedited review
procedures as an acknowledgement of the vulnerability of prisoners as a
class. OHRP recommends that the IRB member(s) reviewing the research
include a prisoner or prisoner representative (OHRP 2018).

The Use of Waivers in Prison Research

Research involving prisoners may be approved with a waiver or alteration
of informed consent. However, even if documentation of informed
consent is waived or altered, Subpart C still requires that the subjects be
clearly informed, in advance, that participation in the research will have no
effect on their parole (OHRP 2018).

Federal Review of Prison Research

Prison research funded by the U.S. Department of Health and Human
Services (HHS), including the National Institutes of Health (NIH), must be
certified by OHRP. In addition, research with prisoners that falls into
categories 3 and 4, described earlier in this module, requires federal
consultation and approval. If research is not conducted or supported by
HHS, these requirements do not apply.

When Enrolled Subjects Become Prisoners

If a human subject involved in ongoing research becomes a prisoner
during the course of the study, the researcher must notify the IRB
promptly. All research activities with the now incarcerated
prisoner/subject must be suspended immediately.

The only exception is when it is in the best interests of the subject to

remain in the study. This exception is most often used when the subject is
receiving an intervention providing direct benefits.

In this case, the subject may remain in the study while the IRB makes the
determinations required by the regulations. In addition to the potential
benefit to the subject, the IRB must also consider issues such as whether
the subject can continue to freely consent to participate, whether the
subject's confinement will in any way prevent the research from
continuing as approved, and whether the subject can continue to meet the
requirements of the research.

The IRB should specify, in any findings that are made in approval of
continued participation, that the allowance is limited to a single subject
and cannot be construed as to allow recruitment of prisoners as subjects.

If the subject can be removed from the research without harming the
subject, or if no interventions will take place while the subject is
incarcerated, the research does not need to be re-reviewed because the
subject will not be participating in the study as a prisoner. If the research
does need to be re-reviewed, the IRB must make the required
determinations about the permissibility of the research for prisoners and,
where applicable, OHRP must certify that the research may be conducted.

Accessing Prisoners
There may be different rules and requirements researchers must follow in
order to gain access to prisoners at different facilities.

Jurisdiction
The jurisdiction over a correctional facility may exist at the local, state, or
federal level. Within a state, policies may vary from county to county.
Juvenile correctional systems usually are separate from other state
facilities and may have their own rules and policies. Therefore, accessing
prisoners might involve an entirely different process depending upon the
facility housing the prisoners.

There are also various phases of incarceration, from pre-sentencing to

work release, with differing restrictions on access to the prisoners.
Researchers will need to identify the jurisdiction with authority over access
to the prisoners they wish to study and become familiar with its
procedures.

Gaining Access
A few general comments may be made about
accessing prison populations:

 Correctional systems at the state level will

have a review process. It may be an
administrative process, a permissions
board, and/or could include a review
comparable to that of an IRB. Researchers
who want to do research in a state facility
will need approval from their local IRB and
 the equivalent committee from the state Department of Corrections.
The research may also require certification from OHRP.
 Approval by an IRB is frequently not sufficient to get a researcher
inside a state prison. The superintendent has the final authority to
allow a researcher access to prisoners.
 An essential step in preventing problems entails establishing a
collaborative relationship with correctional department staff while
still in the research design stage. In fact, this step is essential. Staff
with whom to establish collaborations include prison social workers,
psychologists, and custody staff. Researchers should consider how
their proposed studies might help further the mission/goals of a
specific department. For instance, if prison staff are worried about
or experiencing trouble with gangs, the researcher might consider
how the research may lead to information about how to handle or
better understand gang activity.
 As an administrative issue, many penal institutions are willing to
provide access provided that the research is not disruptive to the
institution. Administrators will be concerned with protecting the
safety of researchers, the prison population, and the prison staff. In
addition to safety concerns, there are operational concerns. Is there
office space? Are there enough officers assigned? Are the prisoners
occupied in treatment or work during interview times? If a study
disrupts prison operations, it may not be allowed, even if it is
ethically sound and might yield useful results.
 Local and county jails are less likely to have a formal review process
for proposed research. In the absence of structural protections for
the inmates, the researcher must assume the sole responsibility for
ensuring the ethical conduct of research. Access is dependent upon
local personnel and could vary significantly.
 Juvenile correctional systems may or may not have a formal review
process. If formal processes do exist, they may reside either at the
state level, the local facility level, or both. Research in juvenile
facilities is covered by Subpart D of the federal regulations,
"Additional Protections for Children as Research Subjects," in
addition to the protections for prisoners as research subjects.
 Research with Prisoners

Summary
Persons who are confined or detained by court order have lost significant
rights, and their ability to freely consent is hampered. When research is
conducted with prisoners, researchers and their IRBs have significant
responsibilities, as outlined in the regulations, to take steps to ensure that
they safeguard the rights of prisoners. Prisoners must be allowed to
choose whether to participate in research that is relevant to their lives and
their privacy. The confidentiality of their research data must be protected
to the extent possible.
Research with Children – SBE

Introduction

Based on concerns for the welfare of

children as research subjects, protections
for children that exceed those for adults
were incorporated into the federal
regulations for protecting research
subjects. At the same time, regulators recognized that some research
presents no more than minimal risk to children and allowed for flexibility
in the parental permission and child assent processes.

This module will describe both the required additional protections and the
options for flexible application of the federal regulations.

In addition, it includes a case study about a waiver of parental permission

for children to participate in research.

Learning Objectives

By the end of this module, you should be able to:

 Know how the federal regulations define "children."

 Identify the federal regulations for protecting research subjects that
apply to research with children.
 Describe when research with children may be exempt from the
federal regulations and when it may be expedited.
 Outline the parental permission and child assent processes.
 Apply the criteria for waivers of parental permission and child
assent.
 Describe the requirements for documenting parental permission
and child assent.
Defining Children

According to the federal regulations, children are persons who have not
yet attained the legal age of consent under the applicable laws in the
setting in which the research will take place (Protection of Human Subjects
2018). Generally, though not always, the age of consent is the age at which
minors reach the age of majority and are considered adults.

In the U.S., state law dictates the age of majority. In most, but not all
states, the age of majority is 18. This means that a 17-year-old may be
considered a child when applying the federal regulations for protecting
research subjects. In Alabama and Nebraska, the age of majority is 19 and
in Mississippi it is 21. Some states have a legal process of emancipation
that confers adult status on those who are younger than the age of
majority. The conditions under which children may be released from
parental authority vary by state. In some states, emancipated minors may
have the legal authority to provide permission for their own children to
become research subjects, but may not be able to consent for themselves
unless an Institutional Review Board (IRB) waives the requirement for
parental permission.

The age of majority may be quite different in other countries. It also is

possible that a country may have no legal definition of "majority." In such
cases, researchers have to rely on community standards and practices to
determine whether subjects are considered children or adults.
Regulations That Apply to Research with Children

There may be many layers of regulations and policies when children are
involved as subjects in research, including federal regulations, state and
local law, and institutional policies.

1. The basic federal regulations for protecting research subjects,

known as the Common Rule (45 CFR 46, Subpart A), have been
adopted by numerous federal agencies and departments.
2. The provisions of Subpart D, of the HHS regulations, "Additional
Protections for Children Involved as Subjects in Research."

The provisions of Subpart D must be applied to all research funded

by U.S. Department of Health and Human Services (HHS). However,
some federal agencies have agreed to apply the provisions of the
Common Rule to research with human subjects, but not the
provisions of Subpart D. In that case, institutional policies will
regulate research with children. It is important to always check with
the reviewing IRB and the institutional policy for research involving
children as subjects.

Subpart D includes:
 3. State and local law, and institutional policy, as applicable. For
example, provisions for waiving parental permission for neglected
or abused children cannot violate federal, state, or local law.

Exempt Research with Children as Subjects

The Common Rule describes activities that

meet the definition of research with human
subjects but are not subject to the
provisions of the rule. Subpart D restricts
the use of exemptions with children as
subjects. Only Exempt Categories 1, 4, 5, 6,
7, and 8 may be applied to research subject
to Subpart D if the conditions of the
exemption are met.

Exempt Category 2 parts (i) and (ii) may

only apply for research involving
educational tests or observation of public
behavior when the investigator does not participate in the activities being
observed. Exempt Category 2 part (iii) may not be applied to research
subject to Subpart D, nor may Exempt Category 3 (research involving
benign behavioral interventions with adults).

The exemption categories that may be used under 46.104 with children
when the conditions of the exemption are met are:

Category Research conducted in established

1 or commonly accepted educational
settings, specifically involving
normal educational practices that
are not likely to adversely affect
students' opportunity to learn
required educational content or the
assessment of educators who
provide instruction.

Category Secondary research for which consent

4 is not required.

Category Studies conducted by federal

5 departments or agencies about
government programs (such as,
welfare programs).

Category Taste and food quality evaluations,

6 and consumer acceptance studies
under some circumstances.

Category Storage or maintenance for secondary

7 research for which broad consent is
required.
 Category Secondary research for which broad
8 consent is required.

Limitations to Exempt Research

Exempt Category 2 under parts (i) and (ii) can be used for research with
children under specific circumstances.

Limitations for Category 2 research subject to Subpart D include:

 Research activities are limited to educational tests and observation

of public behavior
 If the research involves observation of public behavior, the
researcher does not participate in the activities being observed
 Research approved with a limited IRB review under part (iii) of
Category 2 (which involves recording information in such a manner
that the identity of the subjects can be readily ascertained) is not
permitted
Research involving benign behavioral interventions (Category 3), in
conjunction with the collection of information, cannot be exempt for
children as it is applicable only for adult subjects.

Expedited Review When Children Are Subjects

Expedited review is an option when the research activities pose no more

than minimal risk to subjects and fall within one or more of the explicitly
defined categories of activity.

With the exception of limits on the amount and frequency of blood that
may be drawn from children, there are no regulatory restrictions on using
the expedited review process when children (minors) are subjects.
Parental Permission and Child Assent

Parental permission is generally required when children participate in

research as subjects.

The General Process

By definition, children are unable to provide informed consent to
participate in research. The basic model when working with children is
that parents (or legal guardians) provide permission for their children (or
wards) to participate in research and then subsequent to the parental
permission the researcher contacts the children. Children then provide
their assent to become subjects. Assent is a child's affirmative agreement
to participate. The absence of dissent should not be construed as assent
when the child is old enough that assent is meaningful. Generally, parental
permission can only override a child's dissent when the health of the child
is at stake.

Although particulars vary, it generally is assumed that children have

limited rights to decide what will happen to them, based on their age and
maturity. At one end of the age and maturity continuum are infants and
toddlers, who are not capable of making a decision about whether to
participate, although they may communicate their dissent if they become
distressed. At the other end of the continuum are older adolescents who
are capable of both making a decision and actively assenting or dissenting
to participate in research.

No guidelines can replace a researcher's knowledge about the children to

be recruited for a study. Researchers should be prepared to support their
proposed assent process either with data or experience-based evidence,
particularly if the children involved have vulnerabilities other than their
youth, or live in a country, community, or society unfamiliar to the IRB.

Child Assent
Federal regulations specify what kinds of information should be included
in an adult consent process. Subpart D notes that the same kinds of
information should be provided to parents when asking them to provide
permission for their children to be research subjects. However, there are
no regulations about the content of the child assent process.

A number of factors should be considered when developing child assent

processes, including the proposed research activity and the age and
maturity of the children involved. When research activities involve
adolescents, whose capacity to understand resembles that of adults, the
assent procedure should be similar to informed consent procedures
designed for adults. If children's age and maturity level limit their ability to
fully comprehend the nature of the research activity, but they are still
capable of being consulted about participation in research, the assent
procedure should reflect a reasonable effort to enable the child to
understand, to the degree they are capable, what their participation in
research would involve.

If a study involves children of different ages, appropriate assent processes

need to be developed for each age group.

Cultural Differences
Researchers may need to take into account the nationality, ethnicity, and
socioeconomic status of their potential subjects in order to design
appropriate parental permission and child assent processes.

Cultural assumptions about the rights of children vary widely. In some

countries or subgroups, it may be inappropriate and perhaps offensive to
ask children to make research-related decisions.

Longitudinal Studies
In order to respect the emerging maturity and autonomy of children and
adolescents in longitudinal studies, some researchers advocate revising
the child assent process as the child grows older, providing more detail
about the study, and reaffirming assent. Once children reach the age of
majority they may sign a consent form for adults.
Risk Level, Parental Permission, and Child Assent

As the risk level of the research increases, Subpart D has increasing

requirements for parental permission and child assent.

Categorizing Risk Level

Subpart D divides research with children into four categories of risk and
related benefits. Each category carries specific review requirements, as
well as parental permission and child assent requirements. As levels of
risk increase and benefits to individual children decrease, review criteria
become more stringent, and the requirements for permission and assent
increase.
Most research in the social, behavioral, and educational sciences will fall in
two of the four categories:

 The first is research with no more than minimal risk (46.404)

 The second is research with more than minimal risk that has the
prospect of directly benefiting the children, provided the risk is
justified in relation to the anticipated benefits (46.405)
The requirements for parental permission and child assent are the same
for both categories: the permission of one parent and assent of the child,
as appropriate.

The definition of minimal risk for children is the same as the definition for
adults.

Minimal Risk:

 The probability and magnitude of harm or discomfort are not

greater in and of themselves than those ordinarily encountered in
the daily life or during the performance of routine physical or
psychological examinations or tests (Protection of Human Subjects
2018)
 “Daily life” refers to the daily life of normal children.
The remaining two categories (46.406 and 46.407) are relevant for health-
related research with greater than minimal risk and no prospect of direct
benefit to the children and, finally, research that is not otherwise
approvable, but may provide an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of children.

Wards
When the research includes children who are wards of the state or any
other institution or entity, there are additional considerations required by
HHS regulations. Pursuant to 46.409, before wards can be included in
research that is greater than minimal risk and approved by an IRB
pursuant to 46.406 or 407 (and referred to the Secretary of HHS if under
407), it must meet the following conditions:

 The research must be either related to the children's status as

wards; or conducted in schools, camps, hospitals, institutions, or
similar settings in which the majority of children involved as subjects
are not wards.
 The IRB must require appointment of an advocate for each child
who is a ward, in addition to any other individual acting on behalf of
the child as guardian or in loco parentis.
State laws and institutional policies may dictate additional protections for
wards as well.

Documentation of Parental Permission and Child Assent

There are documentation requirements when obtaining parental

permission and child assent.

Child Assent
IRBs have the authority to determine the
appropriate manner, if any, of documenting child
assent. Based on such considerations as the child's
age, maturity, and degree of literacy, the IRB should
decide what form of documentation, if any, is most
appropriate. If adolescents are involved in research
where a consent form would have been used if the subjects were adults, it
generally would be appropriate to use a similar form to document an
adolescent's assent. If young children are involved who are as yet unable
to read, documentation should take a form that is appropriate for the
purpose of recording that assent took place.

Parent or Guardian Permission

Documentation of parental or guardian permission for children to become
research subjects is required unless waived by an IRB in accordance with
the regulations.

Waivers of the requirement to document parental or guardian permission

may be approved by an IRB in accordance with the same regulations that
govern waivers of the requirement to document adult consent. Therefore,
such waivers may be permitted under the following three conditions:

 The documentation of consent (informed consent form) is the only

record linking the child to the research, and the principal risk would
be potential harm resulting from a breach of confidentiality. If
subjects wish to have a signed consent form, their wishes will
govern.
  The research presents no more than minimal risk of harm and
involves no procedures for which consent is normally required
outside the research environment.
 If the subjects or legally authorized representatives are members of
a distinct cultural group or community in which signing forms is not
the norm, that the research presents no more than minimal risk of
harm to subjects, and provided there is an appropriate alternative
mechanism for documenting that informed consent was obtained.
When the requirement for documentation is waived, the IRB may require
the researcher to present each subject (or parent or guardian) with a
written statement regarding the research.

Waivers of Parental Permission and Child Assent

An IRB may waive the requirement to secure child assent if either:

1. The capability of some or all of the children is so limited that they

cannot reasonably be consulted.
2. The intervention or procedure involved in the research holds out the
prospect of direct benefit to the health or well-being of the children
and is available only in the context of the research.
The IRB may also waive the assent requirement if the research meets the
same criteria as for waivers of informed consent for adults.

The same criteria may be used for waivers of the requirement to secure
parental permission.

Both the Common Rule and Subpart D include provisions for waiving the
requirement to secure parental or guardian permission if an IRB
determines that the research is designed for conditions or for a subject
population for which permission is not a reasonable requirement to
protect the subjects. However, an appropriate mechanism must be in
place to protect the children and the waiver needs to be consistent with
federal, state, or local law. For example, an important area of inquiry is
why and how certain teenagers come to live on the streets. An
anthropologist wishing to interview teenagers who are runaways or who
have severed ties with their families could not do so if parental permission
was required.
It is also important to note that there are different criteria for a public
benefit or service program.

Waiver of Parental Permission

Summary

The federal regulations include special protections for children that

include specific criteria for the kinds of review that may be used. When
conducting research with children, researchers must develop parental
permission and appropriate child assent processes. Requests to waive the
requirements to secure parental permission and child assent, and the
requirement to document parental permission may be approved by an
IRB.
Research in Public Elementary and Secondary Schools – SBE

Introduction
Conducting research in public schools is a complex endeavor. Researchers
must contend with a wide range of issues, including the availability of
school time and resources for research and the difficulty of securing
parental permission. They also must contend with a number of federal
regulations and laws that govern research in the schools. This module will
outline those regulations and laws and their implications for researchers.

The regulations governing parental permission and child assent apply to

research conducted in public schools. This module will review the
regulations with examples focusing on school-based research.

Learning Objectives

By the end of this module, you should be able to:

 List the federal regulations and laws that apply to research in the
public schools.
 Discuss the impact of the Family Educational Rights and Privacy Act
(FERPA) and the Protection of Pupil Rights Amendment (PPRA) on
research.
 Give examples of research eligible for exemption in the public
schools.
 Identify state and local reporting requirements.

Overview of Regulations That Apply to Research in the Public

Schools
In addition to the general provisions of the Common Rule (the federal
regulations for protecting research subjects at 45 CFR 46, Subpart A), the
following regulations also govern research in the public schools:
  The Family Educational Rights and Privacy Act (FERPA),
sometimes referred to as the Buckley Amendment, gives parents
certain rights over the content of their children's educational
records.
 The Protection of Pupil Rights Amendment (PPRA), amended by
the "No Child Left Behind Act" of 2001, is designed to provide
parental control over the content of surveys, instructional materials,
analyses, and evaluations of minor students. Two levels of control
are provided based upon how the research is funded.
 Subpart D of 45 CFR 46, "Additional Protections for Children
Involved as Subjects in Research," when applicable: Some federal
agencies that have adopted the Common Rule have not adopted the
other subparts to the U.S. Department of Health and Human
Services (HHS) regulations. For example, while the U.S. Department
of Education (ED) has adopted Subpart D, the National Science
Foundation (NSF) has not. Thus, when research is funded by the ED,
the provisions of the subpart apply. They do not apply when the NSF
funds research. Institutions, however, may choose to apply Subpart
D to all research, regardless of the source of funding (federal
oversight would not apply to studies when Subpart D regulations
are voluntarily required by the researcher’s institution).

The Family Educational Rights and Privacy Act (FERPA)

FERPA is a federal law (20 USC 1232g), and
the regulations specific to this law can be
found at 34 CFR 99. FERPA gives parents
certain rights with respect to their children's
educational records. They have the right to
access their minor children’s school records,
the ability to amend those records, and a
level of control over the disclosure of protected information that is found
in such records. The rights transfer to students, or former students, who
have reached the age of 18 or are attending any school beyond the high
school level. Generally, schools must have written permission from the
parent or eligible student before releasing any identifiable information
from a student's record. Information in school records may include
religious affiliation, citizenship, disciplinary status, attendance, gender,
ethnicity, grades/exam scores, test scores (for example, the SAT), and
progress reports.

FERPA allows schools to disclose identifiable records without permission

to certain parties, including organizations conducting research initiated by
a school district or a state department of public instruction.

FERPA applies to any educational institution that receives funds from

programs administered by the ED. This includes public K-12 schools and
postsecondary institutions. It also includes state educational agencies
(SEAs) (state school districts) and local educational agencies (LEAs) (local
school districts).

Schools may disclose, without consent, directory information such as a

student's name, address, telephone number, date and place of birth,
honors and awards, and dates of attendance. However, schools must tell
parents and eligible students that directory information is not protected,
and they must allow parents and eligible students a reasonable amount of
time to request that the school not disclose directory information about
them.

Researchers who themselves are employed by the schools, such as

teachers returning for graduate degrees, must be aware of their dual
roles. As researchers, they do not have legitimate access to information
that they might consult daily as teachers.

The Protection of Pupil Rights Amendment (PPRA)

PPRA gives parents some level of control over their child's participation in
third-party survey research or exposure to instructional materials
developed by researchers. PPRA identifies eight sensitive topics and
includes two provisions for parental approval of surveys and materials
that cover any of the eight topics. Each provision is associated with an ED
funding mechanism: (1) direct funding of a particular research topic by the
department, or (2) general school funding from the department. The
following sections explain how PPRA is applied based on the funding
mechanism.
The eight sensitive topics are (34 CFR 98):

1. Political affiliations;
2. Mental and psychological problems potentially embarrassing to the
student and his/her family;
3. Sex behavior and attitudes;
4. Illegal, anti-social, self-incriminating and demeaning behavior;
5. Critical appraisals of other individuals with whom respondents have
close family relationships;
6. Legally recognized privileged or analogous relationships, such as
those of lawyers, physicians, and ministers;
7. Religious practices, affiliations, or beliefs of the student or student's
parent; or
8. Income (other than that required by law to determine eligibility for
participation in a program or for receiving financial assistance under
such program.)
Note: The No Child Left Behind Act of 2001 modified the PPRA by giving
parents additional rights with respect to "surveying of minor students, the
collection of information from students for marketing purposes, and
certain non-emergency medical examinations" (ED 2019).

Direct Funding of Research by the Department of Education

Under PPRA, if research conducted under an "applicable program" of the
ED asks students to provide information about any of the eight topics
listed above (for example, sexual behavior), parental permission for the
students to participate cannot be waived.
An applicable program of the ED means "any program for which the
Secretary or the Department has administrative responsibility as provided
by law or by delegation of authority pursuant to law" (General Education
Provisions Act 2012). This means any survey that is funded in whole or in
part by any program administered by the department. If research on any
of these topics is funded by ED waivers of parental permission are not
allowed and parents should be given the opportunity to see the research
instruments.

General Funding from the ED

In 2001, parents were given additional rights with regard to the content of
any surveys administered in public schools, not just those funded directly
through a program of the ED. Every public school system that accepts
money from the department (all public elementary and secondary
schools) must develop a policy that informs parents of their rights to
inspect third-party surveys and related instructional materials, and to ask
that their children not participate.

PPRA does not require written parental permission for the use of surveys
and related instructional materials when such use is not funded directly by
the department. However, the Common Rule requires that parental
permission be either secured or waived in accordance with criteria
established within the regulation.

Parental permission must be secured or waived in accordance with criteria

established by federal regulation. When a waiver has been approved,
investigators may wish to, and Institutional Review Boards (IRBs) may
require, that parents be notified that the study will take place, giving them
the opportunity to withdraw their children from the study. Parental
notification can never be substituted for active parental permission if the
criteria for a waiver have not been met.

Note: Even if an (IRB) waived the requirement to secure parental

permission in accordance with the Common Rule, PPRA requires that, in
accordance with school system procedures, parents be notified about the
proposed research and be given the opportunity to ask that their children
not take part (PPRA 2013).
FERPA and PPRA in Private Schools
If research in a private school is directly funded by the ED, PPRA applies. A
private school that does not receive any federal funding is not subject to
the provisions of FERPA or PPRA. Many private and parochial schools are
not governed by FERPA or PPRA because they do not receive federal funds
(although it is important to always check with the record holder if this is
the case). Private colleges and universities generally do receive federal
funding and are subject to FERPA rules.

Subpart D, Additional Protections for Children As Research

Subjects
Subpart D includes sections applicable to research in schools, including:
Note: Such a waiver cannot violate PPRA, when PPRA applies.

Subpart D Limitation on the Use of Exemptions with Children

The Common Rule describes activities that
meet the definition of research with human
subjects, but are not subject to the
provisions of the rule. These activities pose
little or no risk to potential subjects and are
called "exempt." Because exempt research
is not covered by the rule, institutional
policy will dictate how determinations are
made about whether research is eligible for
exemption and how exempt research is
reviewed. Subpart D limits the use of
exemptions for research involving children.
The following activities likely to take place
in public schools may qualify for exemption
(Protection of Human Subjects 2018):

 Exempt Category 1
o Research conducted in
established or commonly
accepted educational settings, specifically involving normal
educational practices that are not likely to adversely affect
students' opportunity to learn required educational content or
the assessment of educators who provide instruction.
 o This includes most research on regular and special
education instructional strategies, and research on the
effectiveness of or the comparison among instructional
techniques, curricula, or classroom management
methods.
o The definition of a "normal educational practice" varies
over time and from community to community. For
example, many school districts have adopted programs
designed to improve interpersonal skills, such as the
widely used "Second Step" curriculum. In those schools,
role-playing to explore conflict resolution strategies may
be considered a normal educational strategy.
 Exempt Category 2
o Research using educational tests (unless an inadvertent
disclosure of identifiable data would create the potential for
harm).
o Observation of public behavior in which the researchers do
not participate in the activities being observed, for example,
playground activities.
 Exempt Category 4
o Research involving the collection or study of existing data or
records if the data are publicly available, for example,
aggregate system-wide data about student or school
performance, or data recorded without identifiers.
The following activities with school children do not qualify for exemption
under Category 2 if subject to Subpart D:

 Research involving surveys

 Research involving interviews
 Observation of public behavior when the researcher participates in
the activities being observed
The following two examples illustrate the application of the exemption
criteria to research in the schools.

Example 1: Reading Comprehension

Elementary school teachers are interested in whether they may improve
students' reading comprehension by teaching them how fiction and non-
fiction texts are organized. Students entering third grade at schools A and
B are tested for reading comprehension in their school district. Before the
new school year begins, teachers at school A participate in a
developmental workshop where a widely available program of
instructional strategies for teaching students about fiction and non-fiction
text structures is presented. Teachers at school A implement the new
strategies in their classrooms. School A outcomes for reading
comprehension will be compared with a comparable population in school
B at the end of the third-grade year.

This study involves commonly accepted educational practices in a commonly

accepted educational setting and is therefore eligible for exemption.

Example 2: Coping with Grief

A researcher wants to study how guided writing and drawing help
elementary school children cope with divorce. She wants to interview
children before and after they participate in the study activities. This
guided activity is not considered normal educational practice.

This study does not qualify for exemption.

Under Exempt Category 1

Under Exempt Category 2

Waivers or Alterations of Parental Permission

The consent paradigm for research with
children requires that parents or legal
guardians give permission for their
children to become research subjects. The
children, when appropriate for their
developmental stage, provide assent
(agreement to participate).
A challenging issue for researchers in the public schools is the difficulty of
securing parental permission. Sending home permission forms is an
unreliable method. The forms might never make it out of the students'
packs or might end up in stacks of papers for busy parents to get to later.
Forms mailed to parents might not be read. Without a high response rate,
it might be impossible to obtain scientifically valid results or to assess
interventions.

These difficulties create tension between the ethical principle of respect

for persons, manifested in obtaining parental permission, and the ethical
principle of beneficence. Benefits to both individuals and communities can
occur only if research results are meaningful. There also is tension
between the ethical principles of respect for persons and justice. It is
possible that those families who already are burdened by poverty or lack
of education are less likely to provide permission for their children to be
involved in research that might provide some direct benefit to them. If
that is the case, there may not be enough of their children enrolled to get
data that are meaningful for those children.

The Common Rule provides four criteria for waivers or alterations of any
or all of the elements of informed consent. Subpart D allows waivers or
alterations of parental permission and child assent in accordance with the
four criteria of the Common Rule. In addition, the subpart allows for
waivers or alterations of parental or guardian permission when
permission is not a reasonable requirement to protect subjects, for
example, neglected or abused children, provided an appropriate
mechanism for protecting the children is substituted.

In order to waive or alter any or all of the elements of informed consent in

accordance with the Common Rule, an IRB must find and document that
the following criteria have been met (Protection of Human Subjects 2018):

1. The research involves no more than minimal risk to the

subjects. As defined in 45 CFR 46.102 (Protection of Human
Subjects 2018), "minimal risk" means "the probability and
magnitude of harm or discomfort anticipated in the research are not
greater in and of themselves than those ordinarily encountered in
daily life or during the performance of routine physical or
 psychological examinations or tests." Research with more than
minimal risk would introduce risks not normally part of the daily
experience of school children.
2. The research could not practicably be carried out without the
requested waiver or alteration. The researcher must explain the
reasons why the waiver is essential to the study. Inconvenience and
expense are not acceptable factors in making a determination about
"practicability." There may be studies in which the participation of all
students in a classroom is needed in order to obtain valid scientific
results. If all other criteria are met, such studies may qualify for a
waiver of parental permission.
3. If the research involves using identifiable private information
or identifiable biospecimens, the research could not practicably
be carried out without using such information or biospecimens
in an identifiable format. The researcher must justify why the
research could not be done with deidentified information.
4. The waiver or alteration will not adversely affect the rights and
welfare of the subjects. Laws, including FERPA and PPRA, as
described earlier in this module, define some parental rights.
However, neither "rights or welfare" nor "adversely affect" are
defined in the regulations protecting research subjects, so an IRB
must interpret what they mean in the local context. As always, the
IRB may consult with the researcher, the schools, or other experts.
5. Whenever appropriate, the subjects or legally authorized
representatives will be provided with additional pertinent
information after participation. This process is usually referred to
as "debriefing."
Many IRBs require that researchers tell parents about a study even when
it has approved a waiver or alteration of parental permission. In essence,
parents may be offered the option of entering into a permission process
even though it is not required.

A waiver of documentation of consent (signed consent) can be approved

by the IRB as well, if certain criteria are met (Protection of Human Subject
2018). The IRB may require the researcher to provide subjects with a
written statement regarding the research when waiver of documentation
is used (Protection of Human Subjects 2018).
 Child Assent
"The federal regulations give IRBs the responsibility to decide whether
child assent is required and whether assent must be documented. Factors
to be considered include the age and maturity of the children as well as
cultural factors in the communities in which the research will take place"
(OHRP 2011).

Care should be taken so that children do not feel pressured into

participating in research. When research is conducted in the schools,
younger children may need to be reassured that their teacher will not be
mad at them if they don't want to take part in the research activities.
Alternative activities should be made available that do not single out
children who choose not to take part. Adolescents who might be
vulnerable to peer pressure may need privacy to make their decisions.

School is a place where children are encouraged to give the right answers
to questions. Depending on the age of the children, it may be appropriate
to tell them that there are no right or wrong answers to the researcher's
questions.
Summary
Research in public schools is covered not only by the federal regulations
for protecting human subjects, but also by additional federal acts and
regulations that define students' and parents' rights in educational
settings. Nonetheless, there are flexibilities in the regulations that make it
possible to conduct research in the schools while ensuring the protection
of students' rights and welfare, such as waivers of parental permission for
some kinds of research.
International Research – SBE

Introduction
Conducting international research often
involves managing multiple sets of
regulations, policies, and customs: those of
the researchers' institution, the host
country, the community where the research will take place, collaborating
institutions, and U.S. agency sponsors. Even an unfunded researcher
working alone who will simply approach people in the street for brief
interviews may need to acquire a considerable amount of information
when planning the research, including the nature of social interactions,
potential risks of harm, and views about privacy unique to the setting, as
well as whether local permission to conduct research is required.

This module will discuss how to determine where research conducted

abroad must be approved. It will identify some examples about how the
setting of the research influences research design, including
considerations about securing informed consent outside the U.S.

Learning Objectives

By the end of this module, you should be able to:

 Provide examples about how local context influences research

design.
 Identify when institutions are engaged in research.
 Determine where research should be reviewed.

Applicable Regulations and Guidelines

Federal regulations for protecting research with human subjects,
supplemented by guidance from the Office for Human Research
Protections (OHRP), are quite specific about the requirements for review
when U.S. agencies fund research conducted abroad. With the increase in
international collaborations, especially research designed to address
health issues in emerging nations, requirements for local review are
evolving. For example, African nations are increasingly likely to require
national review of all research, including research in the social and
behavioral sciences.

It is beyond the scope of this module to identify national and local review
requirements and practices around the world.

OHRP has compiled a list of international standards for human subjects

research listing over 1,000 laws, regulations and guidelines. OHRP also has
compiled a more specific list of international standards for social and
behavioral research that may be useful.

The National Institute of Allergy and Infectious Diseases (NIAID) (a

department of the National Institutes of Health [NIH]) created an online
database listing country-specific clinical research regulatory information at
the website ClinRegs.

Local contacts and other researchers may be the best resources for
researchers in the social and behavioral sciences and the humanities.

The Importance of the Local Research Context

It is essential that researchers have sufficient knowledge of the local
research context to be able to design and carry out research in a way that
protects the rights and welfare of the subjects. The local research context
includes socioeconomic, political, and cultural factors, and influences
every aspect of the research design.
An effective child assent process requires an understanding of how
relationships between parents and their children are defined. Questions
that may be innocuous in the U.S. could be offensive elsewhere. Different
cultures have different authority structures that will influence how
researchers handle the possibility that people may feel compelled to
become research subjects.

Researchers may wish to consult with community leaders and

stakeholders who may be able to provide important insights about the
local research context, including information about local customs, norms,
and laws.

Similarly, Institutional Review Boards (IRBs) must have sufficient

information to meaningfully evaluate the proposed research and may
engage consultants to supplement its expertise.

Securing Local Approval

Even when the federal regulations do not require review by an IRB or
ethics committee in the country or region where the research will take
place, local, or even national approval of proposed research may be
required in some countries. For example, an ethnographer conducting
research in a village in northern Togo needed clearance, first, from the
Togolese government's Ministère de la Recherche Scientifique; then, from
the Préfet of the canton in northern Togo; then, from the Chef (chief) du
Canton, the Chef du Village, and the Chef du Quartier. Then the researcher
secured the consent of the subjects.

Determining Where Research Should Be Reviewed

There are several factors that determine what kinds of review are needed
for international research.

Research without Foreign Collaborators

If international research is carried out without the involvement of foreign
collaborators the research may be reviewed by the researcher's home
institution. The need for local review will be determined by policies and
regulations rather than by U.S. law.

When U.S. researchers collaborate with researchers at foreign institutions,

determining the appropriate review type and method depends on
whether the collaborating institution is engaged in the research.
 "Engagement" in Research
Briefly, an "engaged" foreign institution is one that recruits and secures
consent from subjects, conducts research procedures, or receives or
shares private, identifiable information.

Institutions are not engaged if their employees or agents (OHRP 2008):

An institution is not engaged if its only involvement is to provide space for

the U.S. researchers to conduct their own research.
If a determination has been made that a foreign institution is engaged in
the research, the next question is whether the research is federally funded
and by which federal agency.

Federal agencies sponsoring international research usually require that

collaborating institutions have written assurances describing how they will
protect research subjects. The content of those assurances is dictated by
the sponsoring agency with varying degrees of specificity. If the research is
funded by the National Institutes of Health (NIH), for example, the
assurance must include procedures that are commensurate with the U.S.
Common Rule (45 CFR 46, Subpart A).

Federal regulations acknowledge that local customs, norms, and laws

where the research will take place may differ from the U.S. Common Rule.
There are different standards and principles that foreign institutions may
comply with. The Common Rule 2018 Requirements do not require that
assurances include a statement of the principles governing the institution
(the pre-2018 Requirements did) (Protection of Human Subjects 2018).

Standards include, among others:

 Canadian Tri-Council Policy Statement

 Indian Council of Medical Research (ICMR)
 Council for International Organizations of Medical Sciences' (CIOMS)
"International Ethical Guidelines for Biomedical Research Involving
Humans"
 World Medical Association’s Declaration of Helsinki
Foreign collaborators may have their own IRBs or comparable review
committees. If not, they may designate another IRB willing to review the
research as the IRB of record. That IRB could be the U.S. researcher's IRB
or another IRB in the foreign country.

If a collaborating institution is not "engaged" in the research, assurances

of compliance are not required.
Exempt Research
A great deal of research in the social and behavioral sciences may qualify
for exemption from the federal regulations, depending upon institutional
policy. If a proposed study qualifies for exemption, federal regulations do
not require review at the foreign site where it will be conducted. Similarly,
OHRP's guidance about engagement in research does not apply to exempt
research. Institutional policy will determine how exempt research
conducted abroad will be reviewed and the required qualifications of
reviewers.

Informed Consent
The points to consider when obtaining
informed consent in non-U.S. settings
include:

 In addition to the consent of the

research subjects, are there other
individuals or groups whose
permission must be sought? Sometimes, in non-U.S. communities,
people other than the individual taking part in the research may be
required to give permission before the potential subject may be
asked to participate. These individuals may include a spouse, a head
of household, or a group leader. However, another individual's
permission should not substitute for a subject's voluntary informed
consent unless an IRB or equivalent local review committee has
waived that consent process.
 What is the appropriate language for the consent? In many
settings, there may be several languages, such as an "official" state
language and a local language or dialect. Consent is best obtained
using the language that is most understandable to the subject.
 Should consent be oral or written? In some instances, the
language used to obtain informed consent is not a written language.
In other instances, the people who are considering whether to take
part in the research may not read the language, even if it is written.
There may be some settings in which signing a document has
connotations that would make a written documentation of consent
 problematic. The researcher should gather information about what
the situation is in the research setting and propose an appropriate
approach for obtaining and documenting consent.
 Who can act as an interpreter? Ideally, the research team is fluent
in the local language. If this is not the case, the researcher must
have individuals assist who are fluent in this language. However, the
researcher must carefully consider the relationship between the
interpreter and the subjects, especially in a small population. While
most IRBs agree that using children as interpreters is not
appropriate, there may be a disagreement about whether adult
relatives, residents of a small village, or others already known to the
subjects may be employed in this role. The issues used to determine
who can interpret include the possibilities of undue pressure or
influence, selection bias, and the extent to which the chosen
interpreter can relay information between researcher and subjects
in a clear and unbiased manner. For example, interpreters may
leave out information they believe is unpleasant or culturally
inappropriate.
 What is the age of majority in the country where the research is
taking place? The age of majority should be the recognized age of
majority in the country or region where the research takes place.
 Do the parental permission and child assent processes reflect
local norms? An effective child assent process requires an
understanding of how relationships between parents and their
children are defined.
 Is there a local contact person? When research is conducted in the
U.S., researchers are required to provide contact information for
their IRB, or another impartial contact, in case subjects have
questions or concerns regarding the research in which they are
participating. In an international study, it may be important to have
a local contact identified by the researcher in consultation with the
community and the IRB.

Summary
Research conducted abroad may need review only by the researchers'
institution. However, some research with collaborators may need multiple
kinds and levels of review depending upon the funding source and nature
of the collaboration. These reviews are focused on applying ethical
principles to research methods and interactions with human subjects in
the context in which the research takes place.
Internet-Based Research – SBE

Introduction
Today more than ever, researchers are
using the internet to do research – both as
a research tool and as the object of
study. Let us consider some ways the
internet can be used in research…

However, researchers must deal with

ethical issues unique to the internet
environment. These issues, such as the
difficulty of confirming the adult status of
online subjects, the "personhood" of pseudonymous online identities, and
the potential re-identification of de-identified data, do not have ready
solutions.

When using social media sites or platforms for online communities,

researchers first should confirm their proposed study would not violate
the sites or platforms terms of use agreement. Similarly, when using
online research tools and services, such as online survey builders or
automated speech-to-text transcriptions, researchers must become
familiar with the privacy and confidentiality policies offered by the
companies to ensure they are adequately protective. Researchers must
become conversant with new technologies, particularly when sensitive
information must be safeguarded, which is critical given the ever-evolving
landscape of living in world where so much of our day-to-day takes place
virtually.

This module will raise some issues for discussion and offer guidelines for
protecting subjects and data in consideration of emerging technologies
and the rapidly evolving uses of the internet.

Learning Objectives

By the end of this module, you should be able to:

  Identify some of the ways in which social, behavioral, and
educational researchers are using internet technologies.
 Discuss the application of the federal definition of research with
human subjects to internet research.
 Discuss how ethical principles that guide research with human
subjects can be applied to internet research.
 Identify some of the issues that must be addressed when designing
a research study that uses the internet.

The Internet as a Research Tool and as the Object of Study

Researchers can use the internet to conduct research with human
subjects in two ways. They can:

Researchers may use the internet to help them conduct their studies.

Examples of internet research tools include…

Researchers may use the internet as a research setting in which they

merely observe people's online behavior, often requiring little or no
interaction with subjects.

Examples of internet research environments include…

Researchers also can use computer programs to extract information from

people's profiles on social networking websites or online communities.
This method of data collection is known as "data scraping." Although data
scraping may provide researchers a wealth of useful data with little effort,
it presents several ethical issues that require consideration regarding
informed consent, data security, and privacy.

Internet-Based Research: Applying the Federal Regulations

and Ethical Principles
The federal regulations and ethical principles should be applied to
internet-based research.

Applying the Federal Definition of Research with Human

Subjects to Internet-Based Research
According to the 45 CFR 46, Subpart A (the Common Rule), "human
subject" and "research" are defined separately.

However, both definitions must be met to qualify as human subjects

research, which is a systematic investigation (intent to contribute to
generalizable knowledge) involving living individuals about whom a
researcher conducting research obtains information through intervention
or interaction with the individual, and uses, studies, or analyzes the
information or obtains, uses, studies, analyzes, or generates identifiable
private information (Protection of Human Subjects 2018).

Living Individuals

Asking subjects to complete an online

survey or studying behavior in an online
support group would meet the definition of
research with human subjects because
there are live humans about whom
information is being collected and the
researcher is interacting or intervening
with them.
However, determining if you are collecting information about or
interacting with "live human beings" may not always be clear in internet-
based research.

For example, suppose a researcher wants to study avatars in virtual

worlds. Avatars are characters that represent a "real world" user online,
such as on MMORPGs or online communities, and are used to interact and
engage within the virtual world. Users can generally customize the
physical appearance of their avatars, as well as their avatars' personality
and character information. On some online platforms, it is understood
that the information making up an avatar's character is fictional, such as
avatars on the MMORPGs World of Warcraft and Final Fantasy XIV: A
Realm Reborn game. However, on some online platforms, such as web
forums and groups, it may not be clear (TechTerms.com 2013).

Furthermore, researchers need to be aware that online landscapes may

also make use of Non-Player Characters, also known as Non-Person
Characters or Non-Playable Characters (NPCs). Although NPCs may look
like an avatar, and in some instances be considered a "virtual human,"
they are not avatars because they are designed and controlled by a
computer through artificial intelligence.

If you obtain consent from an avatar, does the avatar become a human
subject, by default, because it is controlled by a human? Do you need to
obtain consent to use an avatar's information even if it is likely to not be
representative of the human user?

There is also evidence suggesting that the way in which researchers use
their own avatars could affect how the individuals they are interacting with
in the virtual world not only perceive others but themselves as well (Davis
& Murphy, et al 2009; Fysh 2021; University of Texas at Austin 2009).

Interacting/Intervening

As already noted, there are several ways in

which researchers can use the internet as a
research tool or as the object of study.
Generally, when researchers actively engage and interact with individuals
online to collect data, it is likely they are using the internet as a research
tool. Conversely, if researchers collect data from individuals by merely
observing the way people interact or behave online, it is likely they are
using the internet as the object of study. But the degree to which
researchers interact and intervene with subjects also may vary.

Determining how the data are collected may help guide other aspects of
the study's implementation, such as informed consent, privacy, and
confidentiality protections. For example, the way subjects consent to an
online survey is not the same way they consent to a Zoom interview.
Similarly, the way researchers apply privacy and confidentiality protections
will differ if the information collected is from a private online support
group or from a public blog.

Private Information

According to the Common Rule (Protection of Human Subjects 2018),

private information is information that an individual can reasonably
expect will not be observed or recorded. In internet-based research,
issues about private information usually pertains to using the internet as a
research setting.

One method to determine whether content on a webpage is public or

private is to consider how a researcher can access the material. If the
material could be accessed only by registering an account and logging in,
then one could argue that the content on that page is private; whereas
any material that could be accessed without an account or by logging in,
could be considered public. However, this method may not be applicable
to all websites or services.

For example, some websites (such as the photo and video sharing social
networking application Instagram or the online music search engine
Grooveshark) allow users to access their content for a limited time, or up
to a certain number of "hits," or a number of requests to view or access a
file or page. After users have reached the site's threshold, the site might
ask or require users to log in to continue accessing content. Do websites
with these types of limitations provide researchers with information that is
considered public or private?

Another method is to consider what the users' expectations are about the
privacy of their online behavior.

People use the internet to share information about themselves everyday

through different platforms like YouTube, TikTok, Facebook, Instagram,
Pinterest, Twitter, Nextdoor, FitBit, LinkedIn, and many more.

Users of these sites and services can share identifiable information about
themselves, such as their full legal names, birthdates, email addresses,
Global Positioning System (GPS) coordinates, job titles, and employers.
However, users may not know or lose sight of the fact that the information
shared may be public by virtue of it being posted on the internet. What
responsibilities do researchers have in determining their subjects'
expectations of privacy?

If it is reasonable to expect that some individually identifiable information

available online is public rather than private, collection of that information
may be compared to collecting information about people from a local
newspaper. Institutional Review Board (IRB) review would not be required
in this case because there is no expectation that information published
about us in newspapers is private. However, individuals may have privacy
expectations that are at odds with the technology they are using. For
example, people in online support groups may consider their
communications within the group to be private even if the group is
publicly accessible. Their expectation may be that their communications
within the group are not to be observed and recorded for purposes such
as marketing or research. This expectation is not consistent with the
reality that many online support groups are public and that millions of
people can access these groups' online communications.

Users of social networking sites, such as Facebook or Twitter, may or may

not understand the privacy settings available to them. On the one hand,
they may post information quite publicly while assuming their information
is private. On the other hand, users may have a thorough understanding
of the privacy settings they apply to their profiles, but fail to realize that
the site could change the privacy settings outlined in its terms of use
without notice unless required by law (Facebook 2021). Still, even the
savviest of users may delete their accounts and request the removal of all
their information without understanding that third parties and search
engines could retain copies of their information while their account had
been active (Twitter 2021).

Do researchers have any obligations to naïve users of these kinds of sites

when assessing what is a reasonable expectation of privacy?

Researchers and their IRBs or research ethics boards should both take an
interest in understanding subjects’ privacy expectations and third parties’
policies, and user agreements or terms of service to ensure subjects are
adequately informed and protected in research.

Individually Identifying Information

Protecting subjects' privacy as well as the confidentiality of identifiable

study data requires considering the ways people identify themselves when
using the internet. For example, individuals' internet identities may be
very different from their "real" (or offline) identities. Although researchers
may not use a subject's real name, that subject's online username may
serve as that subject's internet identity. In this scenario, a subject's online
name is considered a direct identifier. Similarly, if a researcher reports on
the features and attributes of an individual's avatar (for example, the race,
job classification, and ranking), this may indirectly identify the individual.
Should researchers afford individuals' online identities the same
protections as their offline identities?

There are other re-identification methods unique to the internet. For

example, direct quotes can be traced to a Twitter account without the
user’s handle (Odwazny 2013).

Participants identities may be “rendered identifiable” if unique data points

about them are “mined and matched” across different data sets, even if
those same data points are not sufficiently identifiable on their own (HHS
2013). These unique data points are often referred to as “indirect
identifiers” or “partial identifiers” (Odwazny 2013, HHS 2013). The way data
are collected and transmitted online may make them vulnerable to
inadvertent breach in confidentiality. For example, data existing in a digital
space can be retained indefinitely. Researchers may want to consider
understanding the “data life cycle” on the most commonly used online
research sites and tools (HHS 2013). Presenting findings can also increase
the likelihood of “re-identification by triangulation” (Odwazny 2013) if, for
example, researchers propose to use graphics, such as a social networking
map (AAPOR). Finally, information that may not seem sensitive or
identifiable at the time of collection may become sensitive or identifiable,
inadvertently, as technological advances help researchers link, combine,
and analyze data.

One unique data point that could, conceivably, be used to re-identify

someone is an Internet Protocol (IP) address. An IP address is a unique
identification number assigned to every computer connected to the
internet, and is used by websites to send and retrieve information. It is
said the internet "runs on IP addresses," which is perhaps the reason why
it is quite simple to trace an IP address. In fact, there are several sites that
provide users with instructions on how to trace an IP address in a matter
of steps.

Though it is not always possible to track down a specific individual using

an IP address alone, the Health Insurance Portability and Accountability
Act (HIPAA) Privacy Rule considers IP addresses direct identifiers, as does
the General Data Protection Regulation (GDPR), the European Union’s
privacy protection and security law (OHRP 2010; HHS 2012b; GDPR 2016).
Some online research service providers, such as the survey tool-builder
Qualtrics, offer researchers the option to be given their data without an IP
address as an added measure to protect the confidentiality and privacy of
respondents.

Applying Ethical Principles to Internet-Based Research

Respecting the autonomy of subjects and minimizing potential risks of
harm to subjects are ethical principles most relevant to internet-based
research.
 1. How can researchers respect the autonomy of subjects in internet-based
research?

Respecting the autonomy of subjects requires researchers to give

prospective subjects adequate information to make an informed decision
before agreeing to participate in a study. This is done through the
informed consent process, which includes:

1. Providing subjects with the information they need in order to decide

whether to take part in a study
2. Documenting that the information was provided and that the
subject volunteered to take part in the study

Read more about information provided in online consent forms…

Documenting consent online is quite different from documenting consent

in person. Documenting consent in person often consists of a signed form
that researchers and subjects keep in their possession. The challenge in
designing a consent process for online studies is that they usually do not
provide an opportunity for the researchers and subjects to directly
interact.

Fortunately for researchers, HHS regulation allows them to obtain an

electronic signature as a way to document consent (HHS 2012a). These
regulations permit consent to be documented in a tangible format (written
or in writing) which includes paper or electronic (Protection of Human
Subjects 2018). An electronic signature can be an embedded image of a
subject's signature, a handwritten signature produced by a tablet
computer, or encrypted digital signature (Thompson 2012). Researchers
with access to electronic informed consent (“eConsent”) platforms or other
electronic signature software, like DocuSign, can make use of these
technologies in their studies. For research that is subject to FDA
regulations, the electronic signature requirements of 21 CFR Part 11 would
apply.

Nonetheless, the Common Rule allows IRBs to waive the requirement to

document consent from subjects, as long as the study presents no more
than minimal risk of harm to subjects and the research does not involve
procedures requiring consent outside the context of participation in the
study. However, waiving the requirement to document consent does not
waive the requirement for providing a consent process.

One method of providing a consent process is to design an online consent

form that includes a "live button" that subjects can click to demonstrate
their consent. This version of an online consent form should include a
statement to the effect of, "Clicking below indicates that I have read the
description of the study and I agree to participate in the study." This way,
subjects are actively demonstrating their consent to participate. Note that
this process does not produce a signed consent form for subjects or
researchers to store as part of their research records.

Other methods for securing consent for online studies include obtaining
an electronic signature, as noted above, or sending a paper consent form
to the subject via mail. Although the latter method produces a signed
consent form, it also requires that the researcher collect personally
identifiable information about their subjects that may not be necessary
(Thompson 2012). Further, it may seem a little antiquated and
burdensome to participants.

Researchers who may be using a fixed subject population restricted to a

designated organization, such as students at a certain university or
employees at a specific company, could leverage any authentication
systems already in place, like a username and login, as a way to document
consent.

Securing consent online also raises issues regarding children. In the U.S.,
each state determines the age of legal majority, and the age of legal
majority differs from country to country. It can be extremely difficult for
researchers to know for sure if subjects are self-identifying accurately,
such as reporting their age or geographic location.

Using a panel, such as Prolific, can provide researchers with the option to
make their study available only to participants who are of legal majority
age. While this may provide some assurance to the researcher and their
IRB, one must recognize they are essentially relying on whatever
information participants entered when signing up for the panel.

Researchers may use informal age verification measures, such as asking

subjects to provide their age or year of birth, or by stating that subjects
must be considered an adult to participate. However, these techniques do
not guarantee honest responses or compliance. Researchers could make
use of several age verification methods that may prevent minors from
participating in research, such as age verification services (AVS).
Nonetheless, internet research experts argue that these products, though
robust, are not infallible (Thompson 2012). Thus, in the absence of a
foolproof method for determining the ages of internet users, researchers
and IRBs should carefully consider these issues when reviewing some of
the types of online studies endeavored.

Another issue related to respecting the autonomy of subjects and

internet-based research includes incomplete disclosure, deception, and
the complete absence of an informed consent process. The internet offers
researchers compelling opportunities to study behavior unmediated by
the presence of an observer. The internet also provides unique
opportunities for observational research in private settings. For example,
a researcher can register as a member of a closed group with relative ease
to observe interactions among the members, while concealing his or her
identity as a researcher, or use public blog posts about a group of
individuals' private lives for research purposes without the individuals'
consent.

An IRB also may approve studies in which the informed consent process is
completely waived, if it determines that the waiver is justified. For
example, if a researcher wanted to study behavior and interactions among
users of online virtual worlds, such as Second Life, the IRB could waive the
requirement to obtain consent because consenting might alter the
subject's behavior, thus requiring a consent process would make the
research impracticable. In these types of studies, researchers "lurk" to
collect data. In some instances, researchers may even adopt a false
identity or create a fictitious website in order to observe private behavior.
Nonetheless, the relative ease of collecting data without consenting
subjects calls for more discussion about applying ethical guidelines to
research conducted in internet environments. Further, to meet the criteria
for a certain category of exempt research, the HHS regulations require
that if researchers are using deception that subjects prospectively
authorize the deception (that they understand they will be unaware or
misled regarding the nature or purpose of the research) (Protection of
Human Subjects 2018).

As discussed earlier, other issues pertaining to respecting the autonomy

of subjects include whether researchers bear the responsibility to
interpret their subjects' expectations of privacy and how to recognize
those expectations.

Recent Examples of Internet-Based Research

In the past decade, two high profile incidents demonstrate just how
challenging it is to navigate these issues: the Facebook Emotional
Contagion study and Cambridge Analytica scandal.

The Facebook Emotional Contagion study showed that users of social

media sites, like Facebook, may not fully understand all of the terms to
which they are agreeing to when accepting a sites’ terms of use. Read
more about the Facebook Emotional Contagion study and
considerations it raises for future researchers and IRBs…

Lack of consent from Facebook users was also at the center of the
Cambridge Analytica scandal. Read more about the Cambridge
Analytica study and considerations it raises for consent in internet-
based research…
 2. How can researchers minimize potential risks of harm to research subjects in
internet-based research?

The greatest risk of harm to subjects taking part in social and behavioral
sciences research is the inadvertent disclosure of private identifiable
information that could damage their reputations, employability,
insurability, or subject them to criminal or civil liability. Several factors
need to be considered when assessing potential risks. In most internet-
based research, the primary risk of harm is loss of confidentiality.

Re-identification of Data

Re-identification methods are unique to internet-based research.

Two examples of re-identifying presumably de-identified datasets
are the Harvard University study "Taste, Ties, and Time (T3)" in 2008
and the America Online (AOL) search data leak in 2006.

Read more about the T3 study and how an individual at another

organization was able to use indirect identifies to re-identify
the study subjects because the dataset included enough unique
indirect identifiers…

Learn more about the AOL search data leak and how journalists
were able to identify unique users...

Data Storage

How the data are stored also raises confidentiality issues.

Researchers can expect more challenges as technologies such as
cloud computing, continue to develop. Cloud computing is the
storage and delivery of resources, software, and information over an
online network, rather than a physical product (Mell and Grance
2011). Resources, software, and information are uploaded to and
stored on "cloud servers" in the U.S. and abroad. Users can then
access and share these files remotely, and with relative ease.
Encrypting data before uploading it to a cloud server is a
recommended security measure. Saving data to personal accounts
 that are unencrypted (such as a Google Drive or Box account) or to
devices (such as flash drives) is discouraged and potentially not
allowed. Institutions' information security offices usually provide
recommendations for secure data storage.
Data Mining

New technologies continue to pave the way for careers and

professions in data mining. Data mining is a field of computer
science that involves methods such as artificial intelligence,
statistics, database systems management, and data processing to
detect patterns from large data sets (Chakrabarti et al. 2006).
Academic institutions offer training and professional education
courses as well as degrees (bachelor's and advanced degrees) in
statistical methods and data science (Boston University 2012;
Boston University 2022; Cornell 2022; Northwestern University 2012;
University of Virginia 2022). It is important to consider the source of
the data before mining it.

In data mining, researchers may use data scraping techniques to

collect information from online data sources without consent.
However, online data sources may have additional requirements of
researchers. For example, researchers must use a designated
Twitter API, or Application Programming Interface, and submit an
Academic Research application to use Twitter data for research
(Twitter, n.d.).
Unauthorized Access

If email communications are used to recruit subjects, they may not

be secure and may provide a record of subjects' identities. Similarly,
hacking and unauthorized computer access have become an
everyday possibilities that researchers need to anticipate when
conducting research in the digital age. Encrypting data while it is
stored on a researcher's server is a recommended security
measure. It is for these reasons that researchers should collaborate
with information technology professionals to develop a data security
plan. However, even the most careful security procedures used by a
researcher can be voided if the subjects' computers are not secure.
Describing Confidentiality Assurances to Subjects
 As mentioned in the previous section, the informed consent process
should describe the extent, if any, to which the confidentiality of
subjects' personally identifiable information will be maintained. It is
clear that ensuring the confidentiality of personally identifiable
information is challenging in internet-based research, not only for
the data in their possession but data they make available to others.
The terms of use for online research tools and services, such as
survey builders may state that all data collected on the tool will live
on company servers indefinitely. Similarly, sites that offer
automated speech-to-text transcriptions, may include exculpatory
language or clauses waiving any liability for an inadvertent
disclosure of audio files provided to them for transcription. As
stated at the start of the module, researchers must take
responsibility for understanding the privacy and confidentiality
policies for such services, and inform participants of any limitations
to assurances, where possible.

After all, the Common Rule now requires informed consent

processes to explain whether data and any associated identifiers will
be removed and used (or not used) for future studies or distributed
to another researcher without additional informed consent
(Protection of Human Subjects 2018).

Some internet-based research experts have identified several "best

practices" for describing confidentiality protections to subjects.
Some of these best practices include an explanation of how data are
transmitted from the subject to the researcher, how the researcher
will maintain and secure the data, and a discussion to emphasize
that there is no way to guarantee absolute confidentiality
(Thompson 2012; Office for the Protection 2012).
Describing Risks to Subjects

Like in-person consent process with a written form, online consent

processes should also include a statement to describe anticipated
risks if there are any potential risks of harm or discomfort. If
possible, the consent should explain how the researchers intend to
mitigate those risks, or where appropriate, provide a debrief once
participation has concluded.
 For example, if participants will be asked to respond to questions
that are of a personal or sensitive nature, researchers can design
the survey in a way that participants can skip questions. If
responding to each survey item is critical to the study, researchers
should consider including a “Prefer not to answer” option as a
response. Another method, although perhaps a little more
controversial, would be to use the consent process to inform
participants that every question on the survey must be answered
and they should simply end the survey (“close their browser”) if they
get to a question they do not want to respond to.

More recently, researchers designing online interventions in which

they purposefully present participants with inaccurate information
(such as “fake news”) as part of their study now have to mitigate
potential harms that could result from exposing participants to false
information. Incorporating a funneled debriefing process followed
by an actual debriefing script could mitigate potential harms, but
only if participants fully complete the study, arrive at the debriefing
statement, and read it. This is an almost impossible task to ensure
when the researchers have minimal contact with the online
participant.

The Use of Bots in Online Research

While online studies “help researchers reach thousands of geographically

diverse samples relatively quickly” and at a fraction of the cost, online
studies introduce the risk of data integrity because of bots (Simone 2019).
A bot is an automated software application programmed to complete a
task quickly and with little input from the human programmer.

Since 2018, dozens of articles describing the pervasive use and

detrimental affect bots are having on online research studies have been
published. One such article is aptly titled, “Bots on Amazon's Mechanical
Turk are ruining psychology studies” (Stokel-Walker 2018).

There are simple methods to combat bots, such as adding attention or

logic checks, a CAPTCHA task, asking the same question at two separate
points, and including open-ended questions. There are methods that are a
little more involved, like tracking time stamps of a study and flagging IP
addresses to locate international and duplicate IP addresses or IP
addresses using a VPN. Still, programmers can design sophisticated bots
that can mirror average timestamps, create a normal distribution across
responses based on the range for each individual item and even extract
language from the survey to answer open-ended questions (Simone 2019).

While there may not be a surefire way to guarantee online studies will be
“bot-free” (Simone 2019), researchers should take into account the impact
bots may have on the research. This includes the data integrity and
quality, and generalizability of the results, which can make the research
study mean less. This can lead to problems from having inaccurate data,
inaccurate analysis, and then having to repeat the study which increases
time and financial costs.

Summary
Though the internet has much to offer researchers, researchers using it
have several issues to consider before designing an online research study.
Some of these issues include user expectations about the privacy of their
information, informed consent processes, potential for re-identification of
collected data, and that there are no absolute guarantees to ensure the
confidentiality of personally identifiable information. Navigating these
issues becomes much more intricate and complex when adding the fluid
nature of the online world and the rapid development of new internet
technologies into the equation. It is for these reasons that experts in the
field of internet research ethics have described internet-based research as
a "moving target."
Conflicts of Interest in Human Subjects Research

Introduction

Increasingly, researchers in academia are encouraged to partner with

industry to conduct research, or discover and patent their own inventions,
with the eventual goal of bringing unique innovations and therapies to
market. The money received as a result of licensing and commercializing
patents arising from such research is often shared with the organization
that has funded and/or supported the research. This is just one example
of how conflict of interest (COI) is nearly impossible to avoid in academia
today. COIs can also be non-financial and therefore subtler (for example,
in the case of a researcher’s personal desire to secure grants and publish
to improve the likelihood of achieving tenure).

COIs may arise in human subjects research when researchers and/or

organizations have financial or personal relationships that may
compromise or appear to compromise the integrity of the research,
protection of human subjects, and/or reputation of the researchers or
organizations. To mitigate this concern, processes must be in place so that
conflicts are properly disclosed, reviewed, and managed. COIs are
unavoidable, and are not intrinsically bad, as long as a process that
promotes transparency and management is in place.

This module provides an overview of COIs in human subjects research by

identifying when an interest or relationship may result in a COI,
differentiating types of conflicts and when they should be reported, and
discussing challenges and strategies to manage both individual and
institutional conflicts of interest.

Learning Objectives

By the end of this module, you should be able to:

 Define interests and relationships that may result in a conflict of

interest.
 Distinguish different types of COIs in research.
  Identify federal regulations that govern disclosure and management
of individual conflicts of interest.
 Discuss challenges and strategies to manage individual and
institutional COIs (ICOIs) in research.
 Recognize the ethical concerns associated with COIs in research.

Recent History of COI in Human Subjects Research

In 1995, the U.S. Public Health

Service (PHS), a division of the U.S.
Department of Health and Human
Services (HHS) responsible for
oversight of ten federal agencies
including the National Institutes of
Health (NIH) and the Centers for
Disease Control and Prevention
(CDC), became the first division of the federal government to implement
regulations requiring disclosure and management of individual research-
related COIs (42 CFR 50, Subpart F). In 2011, that regulation was revised
and reissued. The goal of the PHS regulation is to promote objectivity in
research by ensuring that PHS-funded research is free from bias due to
researcher COIs. The regulation requires that organizations applying for or
receiving PHS funding have comprehensive policies (including disclosure
and management of individual COIs) and researchers submit financial
interest disclosures no later than the time of the application for PHS
funding.

While many organizations were grappling with implementing the PHS

regulation to identify potential individual COIs, few had considered the
issues that institutional COIs (ICOIs) can present. ICOIs became an issue of
concern in the human subjects research community when a study subject,
Jesse Gelsinger, died as a result of the experimental therapy he received in
the study. In the investigation that followed, it was discovered that both
the researcher responsible for the study’s oversight and the university
where the research was conducted had significant financial ties to the
company sponsoring the research, as well as an intellectual property
interest in the therapy being evaluated in the study (Wilson 2010, 295-
325).
The investigation also discovered that Gelsinger did not actually meet the
eligibility criteria for enrollment (but was enrolled anyway), and the
sequence of events that caused his death was also experienced in pre-
clinical trials (but never reported in the subsequent clinical research plan).

The financial interests of the researcher and university called into

question whether there was potential bias in the way the study was
developed and conducted. As a result of the Gelsinger case, the
Association of American Medical Colleges (AAMC 2002) issued a report
recommending that academic organizations develop policies to identify
and manage institutional conflicts related to human subjects research.

What is a COI?

The term conflict of interest (COI) refers to situations in which financial

or non-financial considerations may compromise, or have the appearance
of compromising, a researcher’s objectivity in meeting duties or
responsibilities (including those associated with research activities). The
potential bias that COIs may impart can affect multiple research activities
including:

 Decisions about enrollment and inclusion/exclusion criteria

 Decisions about the choice of personnel to conduct the study
 Recruitment and consenting of research subjects
 Vendor selection in the purchase of equipment and other supplies
 Data collection, analysis, and interpretation
 Sharing of research results
 Choice of research design and statistical methods
Bias, or the appearance thereof, can be extremely detrimental to research
integrity and erode the public trust in the research enterprise if not
addressed in a transparent manner.

Types of COIs
The two major types of COIs are individual and institutional, which can be
financial or non-financial in nature.
An individual COI may arise when an individual has a personal, financial,
or other interest, which may affect or appear to affect the design, conduct,
or reporting of the research (AAMC 2011).

An institutional COI may arise when the financial or other interests of an

organization or institutional official, acting within his or her authority on
the organization’s behalf, may affect or appear to affect the objectivity of
research conducted under the organization’s auspices (AAMC 2011).

Financial versus Non-Financial COI

One example of a financial COI is a relationship that may have or appear

to have the potential to result in financial gain. Examples of relationships
that may create a financial COI include:

 Consulting
 Participation in industry speaker bureaus
 Ownership or equity interests in publicly or non-publicly traded
companies
 Ownership of intellectual property that has been licensed or
commercialized (for example, where royalties may result). Financial
 conflicts of interest tend to be tangible because they can be seen
and measured. Review examples of financial COI.
A non-financial COI can arise in many ways. The desire for tenure or the
need to produce data in support of an ongoing hypothesis are two
examples of such COIs. Even personal relationships can result in a non-
financial COI. Review an example of a non-financial COI.

Examples of COIs in Human Subjects Research

This section highlights some examples of COIs that may arise in the
context of human subjects research.

Consulting and Advisory Board Membership

Researchers, as experts in their fields, are often sought after to consult,
serve on advisory boards, or participate in speakers’ bureaus for
companies. These opportunities not only bring prestige to the individual
researcher, but also to the organization by which they are employed.
Nevertheless, these types of relationships often create significant COIs at
organizations, and have the potential to bias the design, conduct, and/or
reporting of the related research, and therefore must be disclosed and
managed.

Intellectual Property Interests and Start-Up Companies

In the past few decades, advances in technology coupled with a change in
federal law that allows universities to retain title to intellectual property
developed using federal funds, have resulted in significant improvements
in commercialization of technologies developed in academia (Mowery and
Ziedonis 2000, 187-220). A COI can arise when researchers conduct
studies aimed at evaluating technology they developed and patented.

Many researchers who develop and patent technology while working at an

academic organization go on to create companies designed to
commercialize that technology (often called “spin-off” or “start-up”
companies). After developing a start-up company, a researcher often
serves as an officer or director in that company and may also want to
conduct research sponsored by that company or involving the technology
developed by and/or licensed to the company. Competing interests arise
when an individual is both a researcher employed by the university and an
owner of the company sponsoring the research. These potentially dueling
roles may create COIs and conflicts of commitment, both of which can be
difficult to manage.

Conflicts of Conscience
In the past few decades, another ethical challenge has come to light. It is
referred to as a conflict of conscience, which comes about when a
person has personal convictions that may jeopardize their objectivity in an
area of science. For example, a Jehovah’s Witness working in a hematology
laboratory might not agree with research that takes place in that lab
based on their beliefs. Conflicts of conscience may also arise in stem cell
research. It can be difficult for some researchers to separate their moral
beliefs from their work as scientists.

Institutional COI

An institutional conflict of
interest (ICOI) may be
present when the financial
interests of an organization or
institutional official (acting
within his or her authority on
the organization’s behalf) may
affect or appear to affect the
research conducted under
the organization’s auspices
(Policies of General
Applicability 2011). An organization’s financial interests can include receipt
of gifts from donors, investments, and/or royalties from its researchers’
commercialized inventions. As with individual researcher COIs,
identification and management of ICOIs are integral to maintaining the
public’s trust in the organization, preserving research integrity, and
protecting the rights, safety, and welfare of subjects.
To identify institutional officials’ financial interests that may create ICOIs,
many ICOI policies require such officials (typically, the president of the
college/university, members of the board of trustees, deans, chairs, and
other administrators who have direct control over research being
conducted at the organization) to disclose financial interests that may
result from:

 Consulting
 Advisory board membership
 Intellectual property
 Equity in publicly and non-publicly traded companies
 Service as an officer, and/or director or board member of
companies that may sponsor research or develop or manufacture
products that will be evaluated in research conducted at the
organization
To identify financial interests of the organization itself, periodic disclosure
and review of its gifts, investments, and royalties are important to
maintain transparency to avoid bias in the research conducted under the
organization’s auspices.

Note that to date, no federal regulations exist that govern disclosure or

management of ICOIs. However, accrediting bodies (such as, the
Association for the Accreditation of Human Research Protections
Programs [AAHRPP]) require organizations seeking accreditation to have
an ICOI policy governing human subjects research. Moreover, the AAMC
and Association of American Universities (AAU) jointly issued guidance in
2008 recommending that universities develop and implement broad ICOI
policies applicable to all types of research (not just human subjects
research).

Federal Regulations and Policies Governing Disclosure of Individual COI

Federal regulations and policies governing disclosure of research-related

individual COIs are broad, and in the case of the PHS regulation,
somewhat complicated. The PHS, U.S. Food and Drug Administration
(FDA), and National Science Foundation (NSF) only address individual
financial COIs.
There are some federal COI policies that are broader and may apply to
personal relationships and ICOIs (for example, procurement-related issues
that may create ICOIs). It is important for researchers to be aware of COI
policies at their own organization, which often require disclosure beyond
that required by any applicable federal regulations or policies.

PHS Regulation Regarding Objectivity in Research

Pursuant to the PHS regulation at 42 CFR 50 (Policies of General
Applicability 2011), no later than at the time of proposal submission for
PHS-funded research, each “investigator” named on a PHS proposal must
disclose “significant financial interests” to a designated official at the
applicant organization.

Investigator (researcher) is defined broadly as any person “responsible

for the design, conduct or reporting of research funded by the PHS.”

Significant financial interest (SFI) is defined as “a financial interest

consisting of one or more of the following interests” that “reasonably
appears to be related to the researcher’s organizational responsibilities:”

 Remuneration received from a publicly traded entity in the 12

months preceding the disclosure and the value of any equity
interest in the entity, which when aggregated, exceeds $5,000
 Remuneration received from a non-publicly traded entity in the 12
months preceding the disclosure, which when aggregated, exceeds
$5,000 or any equity interest in a non-publicly traded entity
 Intellectual property rights and interests upon receipt of income
related to such rights and interests (royalties that flow through the
applicant organization are carved out and do not have to be
disclosed)
 Reimbursed or sponsored travel (travel reimbursed or sponsored by
a federal, state, or local government is carved out and does not have
to be disclosed)
When an organization receives a PHS award, before expending any funds
on the project, a committee or assigned individual must review the
disclosures of all researchers on the project to determine whether any
SFIs are related to the research. If there appears to be a related SFI, the
organization must then conduct an analysis to determine whether the SFI
in question rises to the level of being a “financial conflict of interest.” PHS
at 42 CFR 50, Subpart F (Policies of General Applicability 2011) defines
a financial conflict of interest (FCOI) as an SFI that could “directly and
significantly affect the design, conduct or reporting of PHS-funded
research.” If the SFI is determined to be a FCOI, then the organization
must develop a management plan (if possible) and submit a FCOI report
to the awarding agency; the FCOI report contains information about the
researcher’s FCOI as well as controls put into place to manage the conflict.

NSF COI Policy

The National Science Foundation also has a COI policy, found in
its Proposal & Award Policies & Procedure Guide. Like the PHS
regulation, the NSF policy requires researchers to disclose “significant
financial interests” at the time a proposal is submitted to the NSF. The
NSF’s definition of “significant financial interest” differs somewhat from
the PHS definition, but many of the same types of interests must be
disclosed. Any related SFIs must be managed or eliminated prior to
expenditure of funds.

FDA Regulation Governing Disclosure of COIs

The FDA’s regulation governing disclosure of individual COIs became
effective in 1999. It requires applicants submitting marketing applications
for drugs, biologics, or devices to certify the absence of certain financial
interests or to disclose financial interests of researchers who conducted
clinical studies covered by the regulation at 21 CFR 54.4(a) (Financial
Disclosure 2011). The regulation at 21 CFR 54.4(c) specifies that the FDA
may refuse to file any marketing application that does not contain a
disclosure of researchers’ financial interests or a certification that the
applicant acted with due diligence to obtain researchers’ disclosures, but
was unable to do so.

When FDA-regulated studies are conducted at academic organizations,

researchers working on those studies are typically required to disclose
COIs to the sponsor and to the Institutional Review Board (IRB)
responsible for research oversight. If a researcher has a COI related to an
FDA-regulated study, they may be required to have a COI management
plan in place prior to engaging in the research, depending on the policies
of their organization and the reviewing IRB.

It is important to note that the FDA’s threshold for disclosure is much

higher than that specified in either the PHS regulation or the NSF COI
policy. In part for that reason, most academic organizations have COI
policies that align with the PHS regulation and require disclosure at a
lower threshold (some organizations have a zero dollar threshold).
Therefore, researchers must be aware and comply with the COI policy at
their own organization.

Management of COIs

Management of COIs is critical to ensuring research integrity, the public’s

trust in the organization, and the protection of human subjects’ rights,
safety, and welfare. Management of individual COIs is aimed at reducing
the opportunity to bias the research. Management of COIs may include
COI committees and management plans, informed consent form
disclosure language, as well as additional management controls (such as
divesture and independent data review).

COI Committees and Management Plans

Management controls used to reduce a researcher’s opportunity to bias
the research are either included in the study design or are additional
controls put into place by a COI committee, which exists in some
organizations.
A COI committee is a designated group at an organization that reviews
relationships and interests that may create COIs and develops and
approves plans to manage those relationships and interests to minimize
the risk that they will impart bias into the research.

A management plan is a document that explains the procedures or

extras steps to be taken to minimize the risk of bias. The procedures or
protections put into place to reduce the risk of bias are often called
“controls.” Management plans are typically tailored to the specific study
and/or sponsor and the researcher’s financial interests.

Examples of controls used in management plans may include one or more

of the following:

 Adding an independent monitor to the study team to make sure that

the research procedures are transparent
 Creating a safe environment for any research team member and/or
student to report any perceived conflicts that may occur while the
study is being conducted
 Disclosing the potential COI to the subjects in the informed consent
form
 Reducing the researcher’s role in the research if they have a COI
(less interaction with subjects, less data analysis)
 Using an independent third-party review of data
  Ensuring a careful study design, which may include randomization
and blinding
 Disclosure of the COI, including in publications or presentations of
the study results
 Requiring an independent monitor to ensure that student progress
is not affected by the conflicted mentor’s activities (for example,
doing work for the mentor’s start-up company at the expense of
doing work for a graduate or doctoral thesis)

Informed Consent as a Management Tool

One management control commonly utilized by COI committees to further
reduce the risk of bias and protect human subjects is to preclude
conflicted researchers from obtaining informed consent from subjects.
This control is aimed at preventing such researchers from introducing bias
into the research by exerting undue influence on subjects to agree to
participate. Similarly, written disclosure of interested researchers’ conflicts
in the informed consent form is also used to minimize the risk of bias and
protect the rights of subjects.

Example of Informed Consent Form Language with COI

Disclosure

The researcher, Dr. Jane Smith, owns stock in the company that is
paying for the research.

Additional Management Controls

COI committees utilize many tools in COI management plans to protect
the integrity of research and human subjects. One tool is divestiture. If an
individual researcher had a significant conflict that was deemed
unmanageable by other means, divesting (or selling) interests might be
advised as a means of eliminating the source of the conflict.

When a researcher has a COI related to a study, a COI committee may

require a third party (not associated with the research) to serve as an
independent data reviewer, responsible for monitoring the research and
reviewing the raw data at certain pre-determined intervals.
An independent data reviewer is typically someone not involved with
the research who does not have any related COIs (financial or otherwise)
or reports to the conflicted researcher. The independent data reviewer
could be a faculty member within the university who monitors the raw
data generated at that site.

The COI committee may also require researchers to disclose their financial
interests in presentations and publications related to the research as
another additional control.

Inherent controls (controls that are inherent in the study design) can often
minimize the risk that a researcher with a COI may bias the research.

Inherent Controls to Minimize COI

Blinding Researcher to A researcher with a COI

Treatment Arm who is blinded to
treatment arm(s) would
not likely be able to
introduce bias into the
research.

Independent Data Use of an outside third

Analysis party to conduct data
analysis, so the
researcher with the COI
would not be able to
introduce bias into the
data analysis.

In multi-site clinical
trials, data analysis is
often conducted by a
contract research
organization or the
 sponsor rather than by
local researchers who
may have financial COIs
related to the study.

Limiting Subject If a researcher at the

Enrollment at Local organization disclosed a
Site COI related to a multi-
center clinical trial
enrolling 1,500 subjects
nationwide but only
enrolling two subjects at
the site locally, the fact
that less than one
percent of subjects will
be enrolled at the local
site minimizes the risk
that the researcher
could bias the research.

Consulting Related to an Industry-Sponsored Clinical

Trial

Management of ICOIs in Human Subjects Research

ICOIs may be managed utilizing some of the same controls discussed

above for individual COIs (including inherent study design controls,
reduced study roles or responsibilities, independent monitoring or data
analysis, and required disclosure).

ICOIs can often be quite complicated. Therefore, management plans

require the use of unique controls. If an ICOI has arisen because of an
organization’s financial interest, the first consideration may be whether
the organization’s interest can be divested to eliminate the COI altogether.
Divestiture occurs when the organization eliminates its conflicting interest,
usually by selling it (for example, selling its stocks in the medical device
company that is sponsoring a clinical trial, so the organization would no
longer be financially invested in the company and trial outcome).
Divestiture is an example of a management control that can be utilized to
reduce an organization’s motive (whether actual or perceived) to bias the
research.

However, if divestiture is not feasible, the ICOI may best be managed by

involving external entities in the review and approval of the research. For
example, many ICOI management plans require use of an external IRB
when the organization has an equity interest in an entity related to human
subjects research.

If an ICOI has arisen because an institutional official has financial interests

related to the research, management of those interests may be achieved
by removing that official from all lines of reporting tied to the research.
For example, institutional officials are often responsible for approving
research plans within the review process for IRB and grant submissions.
When an institutional official has an interest in a research study they are
tasked with reviewing, it may be prudent for them to recuse themselves
from their normal role in the review process to avoid any perception of
bias.

Just as individual COIs are disclosed in the informed consent form to

subjects, so too are ICOIs. If the proposed research involves both an
individual COI and an institutional COI, it is not uncommon for both
interests to be disclosed in the informed consent document.

Intellectual Property and Faculty Start-up

IRB Members and COIs

To ensure the integrity of the IRB process, IRBs typically have policies
regarding IRB members reviewing research plans when they may have a
perceived or actual COI. Many IRBs also require members to complete
annual COI disclosures. IRB members should not participate in any IRB
action (including the initial and continuing review of any project related to
research in which they have a conflicting interest) except to provide
information requested by the IRB. IRB members are expected to self-
identify conflicting interests and should notify the IRB staff when assigned
to review research in which they have a potential COI (which may require
staff to re-assign the research plan for review to another IRB member).

An IRB member may have a COI when the IRB member or an immediate
family member:

 Is involved in the design, conduct, or reporting of the research.

 Has a financial interest related to the research or that may be
affected by the outcome of the research.
 Has a proprietary interest being evaluated in the research.
 Has a leadership position in or consulting/advisory relationship with
an entity related to the research.
 Any other situation in which an IRB member believes that they may
not be able to deliberate objectively on a research plan.
Generally, IRB members should recuse themselves when the IRB reviews
research in which they may have a COI. The IRB will have a discussion
once the conflicted member has recused him/herself. If the COI status of
an IRB member changes during a study, the IRB member is required to
disclose this to the appropriate official.

Summary

It is important to think about the transparency of any relationship or

circumstance where a reasonable unaffected individual might conclude
that an individual’s decisions might bias the outcome of research. While
there are situations where a COI is obvious, there may be many that are
not obvious. If not dealt with transparently, bias in research or the
appearance of any biases can be extremely detrimental to the integrity of
research and erode the public trust in the research enterprise. When
there are strong efforts to manage the perception of relationships within
research collaborations, and the plan to manage them is followed, it
leaves those evaluating and conducting the research to focus on the data
and avoid the distraction of any potential improprieties.

When organizations have strong compliance programs to ensure

disclosure and management of conflicts, the research conducted within
those organizations and the resulting outcomes can be trusted and devoid
of distraction from any real or potential improprieties. Transparency,
through disclosure and management of conflicts of interest, is critical to
the integrity of research, advancement of science, and the protection of
human subjects.
Unanticipated Problems and Reporting Requirements in Social and Behavioral Research

Introduction
The federal regulations refer to events that increase the risks of harm to
research subjects as "unanticipated problems involving risk to subjects or
others," and require that such problems be promptly reported to an
Institutional Review Board (IRB) and, when appropriate, to federal
agencies.

Learning Objectives

By the end of this module, you should be able to:

 Define unanticipated problems.

 Describe the reporting requirements associated with unanticipated
problems.
 Identify the types of actions an IRB may take in response to
unanticipated problems.

What are unanticipated problems?

The Office for Human Research Protections (OHRP 2007), in its Guidance
on Reviewing and Reporting Unanticipated Problems Involving Risks to
Subjects or Others and Adverse Events, noted that unanticipated problems,
in general, include any incident, experience, or outcome that meets all of
the following criteria:
 Unexpected
Unexpected (in terms of nature, severity, or frequency) given (a) the
research procedures that are described in the research-related
documents, such as the IRB-approved research plan and informed
consent document; and (b) the characteristics of the subject population
being studied.

Related or Possibly Related

Related or possibly related to participation in the research (in this
guidance document, "possibly related" means there is a reasonable
possibility that the incident, experience, or outcome may have been
caused by the procedures involved in the research).

Greater Risk of Harm

Suggests that the research places subjects or others at a greater risk of
harm (including physical, psychological, economic, or social) than was
previously known or recognized.

Which groups should be considered?

Although the definition of unanticipated problems says the problems may
affect research subjects or "others," OHRP does not provide guidance
about what categories of persons are considered "others."

It is up to the institution/IRB to determine which groups should be

considered, for example, they may be close relatives of the research
subjects or members of the research team. They could also be members
of the community in which the subject(s) lives. The determination may be
research-context dependent. The institution/IRB should have written
policies and procedures that address this issue.

Reporting Requirements
The Common Rule (Protection of Human Subjects 2018) states that IRBs
maintain "written procedures ensuring prompt reporting [of unanticipated
problems] to the IRB, institutional officials, and the department or agency
head" (for example, OHRP).

The reporting of an unanticipated problem by the researcher to the IRB

begins the process of assessing the unanticipated increased risk(s) to
subjects or others, and determining what course of action should be taken
to protect the subjects.

Each institution's IRB must have policies on what constitutes "prompt"

reporting, and have procedures for submitting and responding to reports.
OHRP guidance (2007) states that the federal regulations do not specify a
timeframe for reporting, except to say this must be done "promptly."

For a more serious incident, this may mean reporting to OHRP within
days. For a less serious incident, a few weeks may be sufficient.
Researchers should check with their local IRB to determine the
institution's procedures.

For reporting incidents, OHRP’s website includes an Incident Reporting

Form and Instructions for completing the form. Refer also to OHRP
guidance Reporting Incidents to OHRP (2022)  for how to submit incident
reports.
IRB Actions
Actions that an IRB may take include, but are not limited to:

 Requiring modifications to the research plan

 Modifying the consent document or consent process
 Requiring that current subjects be re-consented
 Providing additional information to current and/or past subjects
 Requiring additional training of the researcher and/or study staff
 Reporting the unanticipated problem to federal agencies
 Observe or have a third party observe the consent process and the
research
 Suspension or termination of the research

When to Report to the IRB

Researchers need to know if the event qualifies as an unanticipated
problem involving risks to subjects or others, and when to report to their
reviewing IRB based on IRB and institution’s policies.

Examples of Reportable Events

The following are examples of reportable events. They present a brief
scenario and explanation on why the event would be considered an
unanticipated problem and considerations for the IRB.

1. A researcher studying online communication has recorded online

conversations in a number of closed social network sites. The IRB
has approved a modified consent process where the researcher
disclosed the research on the sites so that subjects understood that
their conversations would be used for research. The researcher
informed subjects that their online identities would not be disclosed
to others.
In the course of the research, the researcher discovered that raw
data that were collected, including the subjects' online identities,
were hacked and the data were out on the Internet.
 The event is an unanticipated problem because it was not expected,
related to the research, and involves risk to subjects.

 The hacking and disclosure could not have been anticipated

and would not have happened if the research had not taken
place.
 In addition, disclosure of personal conversations linked to
subjects' online identity is a breach of confidentiality.
In reviewing this unanticipated problem, the IRB must determine if
subjects need to be informed about the event and whether
additional data security protections are needed.

2. A researcher studying the effects of birth order proposes to

interview college students about their childhood. The interview
questions are solely concerned with ordinary childhood experiences
such as how many siblings the subjects had and their relationship
with their siblings. The IRB approves the study under expedited
review as a no more than minimal risk study.
Shortly after the approval, the researcher contacts the IRB to report
that three of the first five subjects interviewed had acute emotional
reactions.

The IRB treats this as an unanticipated problem because the

reaction of the subjects was unexpected, the reaction was the result
of being in the study, and the negative emotional reaction could be
considered a psychological harm increasing the risk to subjects.

After consultation with a child psychologist, the IRB determined that,

if a subject had a traumatic experience as a child, the wording of the
seemingly innocuous questions could trigger an emotional reaction.

The wording of the questions was modified and procedures were

set up so that subjects who had experienced a traumatic childhood
event could self-screen themselves out of the study. No further
problems were experienced in the study.

Example of a Non-reportable Event

The following is an example of a non-reportable event, that would not be
considered an unanticipated problem. It is important to understand that
for the reportable event to be considered an unanticipated problem, it
must not have been expected in the design or approval of the research.

1. A researcher studying date rape proposes to interview victims at a

university about their experience and subsequent emotional state.
The IRB determines that, because of the likely emotional trauma of
reliving the experience in an interview, this was a more than
minimal risk study.
The IRB approves a procedure where the University Health Services (UHS)
would be notified each time a subject was to be interviewed. During the
study, several subjects had emotional reactions to the interviews. The
researcher contacted UHS each time and a counselor was sent right over.

These reactions would not be considered unanticipated problems and not

need to be reported because, even though the subjects were distressed
and needed support, the events were expected in the research.

Summary
The reporting of unanticipated problems requires researchers and IRBs to
be familiar with not only the reporting requirements, but also with what
constitutes an unanticipated problem. It is important for researchers in
the social and behavioral sciences to note that such events, while not as
common as in the biomedical sciences, are possible and they should be
aware of their duty to report.
University of Delaware - Human Subjects Protections - Social-Behavioral-Educational Focus - All UD
Researchers/Faculty/Staff

University of Delaware

1. University of Delaware Policy:

UD's Federalwide Assurance (FWA)

All of the University of Delaware human subjects research activities,
regardless of whether the research is subject to the U.S. Federal Policy for
the Protection of Human Subjects (also known as the Common Rule), are
guided by the same statement of principles governing the institution in
the discharge of its responsibilities for protecting the rights and welfare of
human subjects of research conducted at or sponsored by the institution.
UD is committed to uphold the principles of the Belmont Report and
comply with all applicable federal regulations for the protection of human
subjects as prescribed in its written Federalwide Assurance (FWA) with
the U.S. Office of Human Research Protections (OHRP) and the
Department of Health and Human Services.

The terms of the FWA apply to all activities involving human subjects
research sponsored by UD, or in which UD faculty, researchers, staff and
students are engaged. A researcher is considered to be 'engaged' in
human subjects research if they are involved in the informed consent
process, data collection, and/or have access to private identifiable data.

Institutional Review Board (IRB)

University policy and the Common Rule require that all
research involving living human subjects be reviewed and approved by an
Institutional Review Board (IRB) prior to its start. The University's IRB
includes scientists and non-scientists, as well as non UD-affiliated
community members. For a listing of current IRB members
see http://www.udel.edu/research/preparing/humansub.html
The IRB is constituted in accordance with federal regulations to ensure the
following:

 The rights and welfare of subjects will be adequately protected;

 Potential risks to research participants are properly assessed and
minimized; and are reasonable in relation to anticipated benefits, if
any, to subjects, and the importance of the knowledge that may
reasonably be expected to result.
 Selection of subjects is equitable.
 Informed consent will be sought and documented by adequate and
appropriate methods.

2. UD IRB Procedures

Meetings
IRB Meetings are held monthly, generally at noon on the third Wednesday
of each month. Meeting dates and times are posted on the Research
Office Calendar of Events.
http://www.udel.edu/research/researchers/calendar.html

Review and Approval Procedures

The level or review a research protocol may require depends on the
nature of the research as prescribed in the federal regulations. There are
three levels of review: exempt, expedited review, and full board review.
Determinations on the level of review required are made by the IRB and
its Office. Guidance on the different levels of review can be found
at http://www.udel.edu/research/preparing/humansub-
protocolreview.html

Exempt and Expedited Reviews

Review of research protocols determined to be exempt and/or fit one of

the expedited categories are done on a rolling basis as they are submitted
to the IRB.
Full Board Review

All research that does not meet the requirements for exempt or expedited
review or presents more than minimal risk to the subjects must be
reviewed by the full board at a convened IRB meeting. At the University of
Delaware, the principal investigator is usually required to be present at
the IRB meeting when the project is initially reviewed. When a student
presents a protocol to the IRB, his or her advisor must also attend the
meeting. To be considered for review at a convened meeting, rotocols
must be submitted on IRBNet (see researcher responsibilities below) on
or before the established deadlines for submission (see the Research
Office Calendar of Events for dates)

Continuing Review or Renewal

Expedited and full board review protocols are approved initially by the IRB
for a maximum period of one year. Exempt protocols are approved
initially for three years. Although reminders of upcoming renewal dates
will be sent from IRBNet, it is the Investigator's responsibility to know
when the protocol will expire and to submit a Protocol Renewal Form in
enough time to allow the IRB to review the project before it expires. If a
project was initially reviewed as full board, the protocol renewal form
must be completed and submitted via IRBNet in time to be reviewed at
a Board meeting before the approval expiration date. Regardless of
the method of approval, projects will be suspended if a completed
renewal form is not received prior to the expiration date noted on the
approval letter.

Amendments

Prior to implementing any changes to a protocol (e.g. changes to the

subject population, instruments being used, or other aspects of the
methodology; changes to the team of investigators involved in the
research), approval must be obtained from the IRB. An Amendment
Form must be completed and submitted via IRBNet. In many cases, the
amendment can be approved in a few days. If the project was originally
reviewed by the full board and the amendment is a significant deviation
from the original proposal, it may require submission for a full board
review.

Unanticipated or Adverse Events and Noncompliance Instances

If a research participant suffers an injury or an unanticipated problem

occurs which may pose a risk to participants, a report must be submitted
to the IRB as soon as the injury or problem is discovered.
An Unanticipated Problem/Adverse Event Form must be completed
and submitted via IRBNet.

Deviations from an approved protocol and procedures, and any

noncompliance with the federal regulations, the state laws, and university
policies and procedures are considered noncompliance instances and
need to also be reported to the IRB as soon as discovered.

3. Researcher Responsibilities
University investigators engaged in research projects involving human
subjects are required to:

1. Submit to the IRB the plans for anticipated research before

beginning the projects and in sufficient time to allow the board to
take action;
2. Provide detail explanation on how the rights and welfare of the
research subjects are to be protected, how informed consent of
human subjects is to be obtained, and whether written consent
forms are to be used; and
3. Seek IRB approval of any changes to a previously approved protocol
prior to their implementation;
4. Report to the IRB any instances of injuries or unexpected problems
involving risks to subjects or others within one week of the
occurrence; noncompliance instances must also be reported to the
IRB as soon as discovered
5. Ensure compliance with the training requirement for the protection
of human subjects and verify that all researchers working with
 human subjects under his/her supervision have received formal
training for human subject research protections; and
6. Report on the progress of approved research to the IRB, as often as
and in the manner prescribed by the IRB on the basis of risks to
subjects, but no less than once per year; and
7. Maintain research records in a manner consistent with the
requirements of 45 CFR46 and the IRB.
8. Respond to Continuing Review and Expiration alerts on a timely
manner. A project can be closed once data collections activities are
complete and the store data
Environmental and Social Dimensions of Engineering Research

Introduction
Engineering research is largely evaluated based
on its risks and reliability. The engineer
profession's principal client is the public at
large; holding paramount the public safety,
health, and welfare. This applies both to
engineering practice and research. Engineers
may be asked if they have appropriately considered human and ecological
impacts, not merely from the way they conduct research, but also in how
that research is or will be applied. Furthermore, whereas all engineering
research should be sustainable, emerging technologies present a
particular challenge, owing to the numerous areas of uncertainty. Could
the design lead to environmental risk and will this risk be distributed
proportionately throughout society? In short, engineering ethics requires
justice. It also requires a commitment to the future, including sustaining
and improving environmental quality and ensuring public health and
welfare.

Learning Objectives

By the end of this module, you should be able to:

 Identify key ethical frameworks relating to ethics and the

environment.
 Discuss risk and other related concepts.
 Describe the importance of sustainability.
 Describe the importance of green engineering.

Advancing Knowledge vs. Utility

Engineering researchers are interested in advancing knowledge but with
an eye toward practice. Engineering practice and research share a
common feature; both call for balance. Society demands that the state-of-
the-science be advanced as rapidly as possible and that there are no
dangerous side effects. This calls for a multivariate approach, with
tradeoffs among numerous options. One of the many strengths of the
engineering practitioner and researcher is the ability to optimize among
numerous variables for the best design outcomes. This approach can be
used not only for technical decisions but also to ensure that these
decisions are ethical.

The individual engineer must abide by the principles of practice and codes
of ethics. For example, the professional engineer in the U.S. must adhere
to the code of ethics of the National Society of Professional Engineers.
Likewise, specific disciplines must adhere to their societies' codes, such as
those of the American Society of Civil Engineers (ASCE 2006) and the
American Society of Mechanical Engineers (ASME 2012). However, such
codes are limited in at least two ways. First, they address general aspects
of practice and, as such, do not speak directly to engineering research.
Second, these codes are solely aimed at the individual engineer. Thus,
larger issues like sustainability and emergent technologies are not wholly
addressed by this "bottom up" approach. Emergent areas are associated
with some degree of peril. A query of top scientists regarding
biotechnologies needed to help developing countries indicates the range
of concerns (see Table 1). The international experts were asked the
following questions about the specific technologies (Darr et al. 2002):
Engineers as agents of technological progress are in a pivotal position.
Societal challenges require that each engineer understand the
implications and possible drawbacks of technological developments. Key
among them will be biomedical and novel technical advances, including at
smaller scales that approach the molecular level, such as
nanotechnologies, because of their potential to impact human health and
environmental quality For example, genetic manipulations can lead to so-
called "gene flow," which means that genetically modified organisms
(GMOs) may share their altered genetic information with native
organisms, so that untargeted populations may irreversibly change. Thus,
there is a possibility of completely displacing native species. This is an
example of dramatic changes in outcome due to seemingly small changes
in initial conditions.

Perspectives on Ethics

The ultimate measure of a man is not where he stands in

moments of comfort and convenience, but where he
stands at times of challenge and controversy."- Martin Luther
King, Jr. ([1963] 1981)
Engineers are comfortable with the dimensional analysis by which they
can measure and describe physical, chemical, and biological attributes of
what they design. But can ethics be "measured" in a similar way?
Longstanding disagreements continue about which specific ethical
tradition to embrace. However, there is widespread consensus that ethics
is a rational and reflective process of deciding how humans ought to treat
each other.

Indeed, engineering ethics is a combination of many different schools of

thought. It is neither completely deontological (duty based) nor
teleological (outcome based). It is a combination of these, based on
reasoning. Engineers not only ask what is their duty and what is the
desired outcome, but why is the project being undertaken in the first place
and are there better and safer ways to accomplish this.

One Means of Describing an Ethical Situation Is By Its Reach in

Space and Time
The engineering profession has a moral responsibility to ensure that designs
and technologies are in society's best interest. In addition, the individual
engineer has moral obligations to the public and to the client. The moral
obligations of the profession as a whole are greater than the sum of the
individual engineer's obligations. The profession certainly needs to ensure
that each of its members adheres to a defined set of ethical expectations.
Political theorist Langdon Winner (1990) has succinctly characterized the
moral imperative to which engineers should adhere by stating that:

Ethical responsibility...involves more than leading a decent, honest,

truthful life, as important as such lives certainly remain. And it
involves something much more than making wise choices when
such choices suddenly, unexpectedly present themselves. Our moral
obligations must... include a willingness to engage others in the
difficult work of defining what the crucial choices are that confront
technological society and how intelligently to confront them.

Kant's Categorical Imperative and Other Approaches to Ethics

One approach to ethics that may help to resolve professional challenges is
offered by the philosopher Immanuel Kant ([1785] 1992). Kant's
categorical imperative states that in order to determine whether
something is ethical, one should consider what would happen if that act
was universalized. In other words, could it become a law adopted by
everyone? If the law upholds the ideal of showing respect for rational
beings, the act is moral; if, on the other hand, it displays a lack of regard
for humanity, the act is immoral. Kant embraced the categorical
imperative as the theoretical underpinning for duty ethics.

The President of Agnes Scott College, Elizabeth Kiss, explains Kant's

categorical imperative in contemporary terms and labels her version the
"Six O'clock News" imperative. If you are pondering whether something is
ethical or not, consider how your friends and family would feel if they
heard about the decision on television news.

Another approach to ethics is offered by John Stuart Mill. His utilitarian

axiom of "the greatest good for the greatest number" is moderated by his
"harm principle". That is, even though an act can be good for the majority,
it may still be unethical if it causes undue harm to individuals.

As professionals, engineers strive for excellence. This is articulated in

codes of ethics, which over time has grown beyond merely a mandate to
avoid actions that are clearly wrong, to a vision of engineering
accomplishments that advance human endeavors. Part of the formula for
ethical behavior is to know who is directly and indirectly affected by
actions, which the aforementioned ethical perspectives may help bring
into focus. Engineers should not simply solve immediate problems for a
specific client. Rather, they should consider the larger public and future
generations.

Engineering ethics can be viewed from the day-to-day perspective of the

practicing engineer or individual researcher. This is known
as microethics. While the codes of ethics stress this category of ethics,
engineers also have responsibilities to society, often referred to
as macroethics. Notable among macroethical responsibilities is the
engineering profession's obligation to protect the environment.

Perspectives on Non-human Species and the Environment

Environmental ethics pertains to those actions held to be right and wrong
about how people interact with the environment. Several major ethical
viewpoints dominate the environmental literature: anthropocentrism;
biocentrism; sentientism; and ecocentrism (see Figure 1).

Anthropocentrism
The philosophy or decision framework entailing that all and only humans
are entitled to moral regard. Nonhuman species and ecological resources
have value only in respect to their usefulness to human beings (known as
instrumental value).
 Biocentrism
A systematic and comprehensive account of moral relationships between
humans and other living things. The biocentric view requires an
acceptance that all living things have moral value. Within this framework,
respect for nature is the ultimate moral attitude. It is encapsulated by
Albert Schweitzer's "reverence for life" ([1933] 1990).

Sentient-centered Ethics
Falls between anthropocentrism and biocentrism. This approach suggests
that all creatures with a nervous system are entitled to moral regard. That
said, this view would cause us to do what we can to prevent or at least
reduce suffering in these other species. Biologists typically suggest that
the difference between humans and animals is a continuum, as indicated
by the development of the nervous system and other physiological
metrics.

Ecocentrism
Based on the notion that the whole ecosystem, rather than just single
species, has moral value. In his seminal work, A Sand County Almanac
([1949] 1987), Aldo Leopold grew to appreciate the ecocentric view and
established the "land ethic." It was a dramatic shift in thinking from that
which was dominated during the first half of the twentieth century.
Leopold (1949) held that this new ethic "reflects the existence of an
ecological conscience, and this in turn reflects a conviction of individual
responsibility for the health of land."

Application of the Frameworks

Applying a single ethical framework in every circumstance can be
problematic. Conversely, extreme biocentrism could halt useful advances
in genetic engineering (for example, genetically modified organisms to
treat hazardous wastes). Yet the awareness of these ethical frameworks
can help to inform decision-making.
Risk, Reliability and Ethics
All design decisions can lead to unanticipated consequences. Some argue
that there is a need to proceed carefully by following a precautionary
principle.

However, the precautionary approach must also be balanced against the

potential for new advances. In other words, by being cautious are
opportunities missed that would better serve the public and future
generations? The key to balancing these connections can be a complete
and accurate characterization of risks and benefits. Unfortunately, design
decisions are often not fully understood until after the fact (and viewed
through the prism of lawsuits and media coverage). Hazardous waste sites
were the major impetus behind risk-based regulations. For example, Love
Canal, Times Beach, and the Valley of the Drums in Kentucky are major
cases that led to regulatory changes. Managing risks to human and
ecosystem health is one of the principal engineering mandates.

Risk
Risk, as it is generally understood, is the chance that some unwelcome
event will occur. The operation of an automobile, for example, introduces
the driver and passengers to the risk of a crash that can cause damage,
injuries, and even death. The hazardous waste cases emphasize the need
to somehow quantify and manage risks.

Understanding the factors that lead to a risk is known as risk analysis.

The reduction of this risk (for example, by wearing seat belts while driving)
is risk management. Risk management includes the policies, laws, and
other societal aspects of risk. Risk management is often differentiated
from risk assessment, which primarily consists of the scientific
considerations of a risk.

Risk and Benefit

Engineers and others must consider the interrelationships among factors
that put people at risk. Designs must be based on the sound application of
the physical and social sciences. Engineers are held responsible for
designing safe products and processes, and they are held accountable for
the public's "health, safety and welfare." Engineers design systems to
reduce risk and look for ways to enhance the reliability of these systems.

Both risk and reliability are expressed as probabilities. As such, the

minimum likelihood is zero and the maximum likelihood is 100% (in other
words, probability can be any value between zero and one). Individuals
living near industries and waste sites, at least intuitively, compare the risks
of living there to other factors such as affordability and proximity to work.
For good reason, they want to be assured that they will be "safe." But,
safety is a relative term. Calling something "safe" integrates a value
judgment that is invariably accompanied by uncertainties. The safety of a
product or process can be described, at least to some extent, in
quantitative terms. Factors of safety are a part of every design.

This raises a key problem for engineers; how can the potential risks,
benefits, and reliability of their designs be properly communicated to non-
engineers? Just because the client or the general public is silent about a
proposal does not necessarily mean they agree. Indeed, they are often in
no position to agree or disagree since the project is quite technical in
nature. Hence, expressions of risk and reliability require trust, akin to the
trust that a medical doctor must gain from a patient about to undergo
surgery that can only fully be understood in highly technical, medical
terms.

All design decisions are made under risk and uncertainty (that is why
factors of safety are necessary). The risk management process is informed
by the quantitative results of the risk assessment process. Managing risks
also must consider other quantitative information, such as economic costs
and benefits, as well as qualitative information, such as opinions shared
by neighbors or community leaders. Thus, in addition ensuring that a
project is the right project for the problem at hand and the project is
executed in a sound manner, the engineer must also be mindful of the
culture and social context of the project.

Engineering as Applied Social Science

Thinking of engineering as applied social science redefines engineering
from a profession that builds things to one that helps people. By
extension, educators must be vigilant about what and how engineering is
taught. So, how do engineers fail to help people?

Engineering success or failure is in large measure determined by

comparing expectations against what has actually occurred. Safety is
always a fundamental facet of our professional duties. Thus, we need a set
of criteria that tells us when designs and projects are sufficiently safe.

Four main safety criteria should be applied to test engineering safety

(Fleddermann 1999):
Failure
The first two criteria are easier to follow than the third and fourth. The
well-trained designer can look up the physical, chemical, and biological
factors to calculate tolerances and factors of safety for specific designs.
Laws have authorized the thousands of pages of regulations and guidance
that indicate when acceptable risk and safety thresholds are crossed,
meaning that the design has failed to provide adequate protection. In
general, only other engineers with specific expertise can judge whether
the ample margin of safety as dictated by sound engineering principles
and practice has been provided in the design. Identifying alternatives and
predicting misuse requires creativity and imagination.
 The Consequences of Failure
Failure in design can go beyond the textbook
cases and those shared by mentors and passed
on from one's predecessors. Two cases that go
beyond the classical types involved Minoru
Yamasaki: the Pruitt-Igoe housing development
and the World Trade Center towers. By most
accounts, Yamasaki was a highly successful
designer. Tragically and ironically, Yamasaki may be best remembered for
two of his projects that failed. The Pruitt-Igoe public housing development
in St. Louis, Missouri was supposed to be emblematic of advances in fair
housing and progress in the war on poverty (Birmingham 1998).
Regrettably, the development became an icon of failure of imagination.
Going forward, designers could probably benefit from the insights of Aldo
Leopold and his contemporaries.

Yamasaki and Antonio Brittiochi designed the World Trade Center towers.
Yamasaki strived to present an aesthetically pleasing structure. According
to this criterion, he succeeded where many architects fail; aesthetic or
operational (for example, ugly or an inefficient flow of people) are more
often the cause of architectural failures than structural problems. Yet the
towers failed when they collapsed (though the designers should not be
blamed for this).

Most post-collapse assessments have agreed that the structural integrity

of the twin towers was sufficient based on what was known at the time of
design. However, future engineers must learn the lessons from this
tragedy and adjust their designs accordingly.

The primary lesson is that engineering is an integrative enterprise. Design

depends not only applied natural sciences but on the social sciences.
Ethics, in particular, is crucial to an engineer's success. We should not miss
opportunities to relate engineering and social science lessons from even
the most life and society changing events (Bailey 1965; Vallero 2002).

Sustainability
One of the principles of green engineering is the recognition of the
importance of sustainability. The recognition of impending global
environmental disasters led the World Commission on Environment and
Development, sponsored by the United Nations, to conduct a study of the
world's resources. Also known as the Brundtland Commission, their 1987
report, Our Common Future, introduced the term sustainable development
as "development that meets the needs of the present without
compromising the ability of future generations to meet their own needs"
(World Commission 1987).

The World Summit on Sustainable Development (WSSD 2002) identified

five major areas that are considered key for moving sustainable
development plans forward:

Sustainable design is analogous to the psychological concept of individual

needs. Maslow was among the first to articulate a similar notion within a
hierarchy of two classes of needs: basic and growth (see Figure 2). This
can be adapted from an individual's personal development to larger
population and ecosystem scales (Maslow 1970).

Basic Needs Applied to Larger Scales

The basic needs must first be satisfied before a person can progress
toward higher-level growth needs. Within the basic needs classification,
Maslow separated the most basic physiological needs, such as water,
food, and oxygen, from the need for safety. Therefore, one must first
avoid starvation and thirst, satisfying minimum caloric and water intake,
before being concerned about the quality of the air, food, and water
(Maslow 1970).

Developing economies often cannot adequately provide food, clean water,

and other basic needs for large segments of their populations. Ironically,
the quest to meet these basic needs can be accompanied by
environmental damage, if not carried out in a sustainable way. Industrial
and economic development is currently occurring in many nations at
substantial costs to environmental quality. For example, air, water, and
soil pollution is increasing rapidly in China, India, and other nations with
growing economies (analogous to the economic and environmental
tradeoffs in the Western hemisphere following World War II).

Another aspect of sustainability is that development must be considered

in a systematic way. What may be acceptable at one scale may be
unacceptable at another. For example, providing the basic needs for one
nation may adversely affect the region or the entire planet, such as the
potential for the release of greenhouse gases that may alter climate at the
global scale.

Growth Needs within the Province of Environmental Protection

The most basic of needs must first be satisfied before striving for more
advanced needs. Providing food requires ranges of soil and water quality
for agriculture. Thus, any person and any culture that is unable to satisfy
these most basic needs cannot be expected to "advance" toward higher-
order values, such as free markets and peaceful societies
Sustainability is a systematic phenomenon. At the largest scale,
manufacturing, transportation, commerce, and other human activities that
promote high consumption and wastefulness of finite resources cannot
be sustained. At the individual designer scale, the products and processes
that engineers design must be considered for their entire lifetimes and
beyond. Thus, the chaotic nature of possible impacts must be considered
by the engineer to ensure that solving one problem does not create a new
one. This is known considering "downstream impacts" in the life cycle.

Implementing Sustainable Designs (Green Engineering)

A common decision tool for engineers is the benefit-
to-cost ratio (BCR). The choice of a pollution control
option may appear to be a simple matter of benefits
vs. costs. The engineer may want to know the
cheapest way to achieve a specified level of
environmental quality. For example, which pollution
control technology is best at 99% removal of a
pollutant from the waste stream? The answer to this
question is clearly supported by the BCR. Thus, utility is a measure of
success of any successful engineering enterprise. After all, engineers are
expected to provide reasonable and useful results. As such, the BCR is a
useful metric due to its simplicity and seeming transparency. To
determine whether a project is worthwhile the benefits are summed in the
numerator and the costs in the denominator. If the ratio is greater than
one, the option's benefits exceed its costs (Vallero 2014).

A problem is that some costs and benefits are much easier to quantify
than others. For example, those associated with quality of life are not
conducive to quantification. Furthermore, the comparison of action vs. no-
action alternatives is difficult or impossible within a BCR. Opportunity
costs and risks can be missed, such as not applying a new technology that
would be more effective. Comparing the status quo to costs and risks
associated with a new technology and/or greener approaches may be
biased toward no action by relying exclusively on proven technologies.

In recent decades, engineers have increasingly been asked to design

buildings, devices, and systems that are sustainable. That is, they provide
the benefits not only to the present users, but do so in a way that future
people will not be harmed by present benefits. This is at the heart of
green engineering. According to the National Academy of Engineering
(NAE 2004):

It is our aspiration that engineers will continue to be leaders in the

movement toward the use of wise, informed, and economical
sustainable development. This should begin in our educational
institutions and be founded in the basic tenets of the engineering
profession and its actions.
Sustainability requires adopting new and better means of using materials
and energy. Operationalizing the quest for sustainability is defined
as green engineering, a term that recognizes that engineers are central
to the practical application of the principles sustainability to everyday life.
The relationship between sustainable development, sustainability, and
green engineering is progressive:
Sustainable development is an ideal that can lead to sustainability, which
can be accomplished through green engineering.

Green architecture and engineering treat environmental quality as an end

in itself (Billatos and Basaly 1997). The U.S. Environmental Protection
Agency (EPA 2017) discusses the importance of the interrelationships of
feasibility, environmental quality, public health, and welfare by stating that
“green engineering is the design, commercialization, and use of processes
and products that minimize pollution, promote sustainability, and protect
human health without sacrificing economic viability and efficiency.”

Decisions to protect human health and the environment can have the
greatest impact and cost effectiveness when applied early to the design
and development phase of a process or product.

Green engineering approaches used to be either absent or retrofitted into

designs. In recent years, however, they have become more fully integrated
into engineering guidelines. The principles underlying green engineering,
along with engineering tools, can help the engineer meet green design
objectives. Green approaches are actually examples of systems
engineering, in other words, rather than focusing on a specific engineering
discipline (for example, civil, mechanical, chemical, or biomedical), the
design is considered from an interdisciplinary perspective for its entire life
cycle.

To learn more about the principles of green programs, refer to Table 2.

Implementing Green Design

Considering a design's entire life cycle can make use of numerous
industrial, commercial, and governmental green initiatives, including
Design for the Environment (DFE), Design for Disassembly (DFD), and
Design for Recycling (DFR) (Allada 2000; Vallero and Brasier 2008a):
These are replacing or at least changing pollution control paradigms.
Policy and regulatory innovations call for improved technology based
approaches as well as better quality-based approaches. This is a
foundation for most sustainable design approaches, in other words,
conducting a life-cycle analysis, prioritizing the most important problems,
and matching the technologies and operations to address them.

Historically, environmental considerations have been approached by

engineers as constraints on their designs. For example, hazardous
substances generated by a manufacturing process were dealt with as a
waste stream that needed to be contained and treated. The hazardous
waste production had to be constrained by selecting certain types of
manufacturing, increasing waste handling facilities, and if these did not
entirely do the job, limiting rates of production.

Green engineering emphasizes the fact that these processes are often
inefficient economically and environmentally, calling for a comprehensive,
systematic, life cycle approach to achieve four goals:

Systems engineering extends an engineer's responsibilities well beyond

the construction, operation, and maintenance stages. An integrated matrix
can be a visual representation of DFE by highlighting the technical and
other factors associated with each component of the design, as well as the
relationships among these components. These can include potential
health risks, social expectations and environmental impacts, and other
societal risks and benefits associated with a device, structure, product, or
activity during the manufacturing, marketing, and application phases;
yielding two-dimensional matrices (see Figure 3).

Each matrix cell indicates both the importance of a particular factor or

component, along with the confidence (scientific certainty) regarding the
underlying information used to assess the importance. The matrix
approach is qualitative or at best semiquantitative, but provides a
benchmark for comparing alternatives that would otherwise be
incomparable. For some designs, it may be possible to assign numerical
values to each cell to compare them quantitatively if the factors can be
weighted. The matrix approach can also focus a specific measure, such as
energy efficiency or product safety (Vallero 2014).
Optimizing for Sustainable Design
Green engineering encompasses numerous ways to improve processes
and products to make them more efficient from an environmental
standpoint. The designer must consider short and long-term impacts.
Sometimes the most profound impacts will be on generations beyond the
current one.

In the mid-twentieth century, designers specified the use of what are now
known to be hazardous building materials, such as asbestos flooring, pipe
wrap, and shingles; lead paint and pipes; and even structural and
mechanical systems that may have increased human exposure to molds
and radon. It is easy in retrospect to criticize these decisions, but many
were made for noble reasons, such as fire prevention and durability of
materials.

Sustainable design requires a complete assessment of a design in place

and time. The effects of a technology can be decades or even centuries
away. For example, the radioactive wastes generated by nuclear power
plants may have half-lives of hundreds of thousands of years.

Sustainable design can be demonstrated using the concept of "carrying

capacity" in Hardin's "Tragedy of the Commons" (1968) wherein he
imagines an English village with a common area where every villager can
allow a cow to graze. At first, the common readily sustains the livestock.
However, this begins to change after one of the villagers decides to graze
two cows instead of one. The cost of the extra cow is shared by everyone,
but the profit will be his alone. Others note his success and
correspondingly each also graze two cows. Their logic is extended so that
if two are better than one, then three must certainly be better than two. At
some point, however, the village common is no longer able to support the
large number of cows, the system crashes and everyone suffers. This
concept can be extended to the using unsustainable practices for short-
term gains, for example, overuse of non-renewable resources and fuels,
and focus on initial costs without adequate attention to operation and
maintenance demands.
Revisiting the Harm Principle: Managing Risks
Mill's harm principle suggests that even when an action can have benefits,
there is a moral obligation to avoid such action if it causes undue harm.
This is a difficult concept for those who operate in the quantitative
domain, as most engineers do. The harm principle becomes even more
complicated when not taking an action can lead to negative
consequences.

Green and biomedical engineering can both require tradeoffs in

addressing different hazards. For example, the choice of using a toxic
substance is complex (see Figure 4). Critical paths and flow charts are
commonly used in design and engineering, especially computing and
circuit design (Vallero and Brasier 2008a; Vallero and Brasier 2008b).

They are also useful in life cycle analysis if sequences and contingencies
are involved in reaching a decision, or if a series of events and ethical and
factual decisions lead to the consequence of interest. Thus, each
consequence and the decisions made along the way can be seen and
analyzed individually and collectively (Fleddermann 2004). Other charts
need to be developed for safety training, the need for fail-safe measures,
and proper operation and maintenance. A "master flow chart" can be
developed to track all of the decisions and subsequent consequences that
ultimately led to the disaster.

Design for the environment (DFE) can be very challenging in the realm of
biomedical engineering. For example, an asthma medication that is
delivered to the lungs using a greenhouse gas (GHG) propellant. At first
glance, the green engineering perspective may forbid it. However, if the
total amount of the propellant used in these devices only constitutes
0.0001% of the total GHG used, perhaps the contribution to global
warming might be considered insignificant. When it comes to public health
tradeoffs, the significance is often determined by medical efficaciousness.
If there are no effective alternatives, the tradeoff with the environmental
effects may be justifiable.

Few, if any, design decisions can be made exclusively from a single

perspective. A design decision can be visualized as attractions within a
force field, where the center of the diagram represents the initial
condition with a magnet placed in each sector at points equidistant from
the center of the diagram (see Figure 5).

The initial conditions will be driven toward influences. The stronger the
influence of a factor (for example, medical efficacy), the greater the
decision will be drawn to that perspective. If the factors are evenly
distributed and weighted, the following diagram might appear (see Figure
6).

But, as the differential in magnetic force increases, that factor will

progressively drive the decision. So, in the greenhouse gas propellant
example, the medical efficacy drives the decision. The stronger the
magnet the more likely that the decision made will be pulled in that
direction (see Figures 7A & 7B).

In greening hospitals, for example, physicians and clinical engineers may

drive the decision in one direction; lawyers may pull in another direction;
whereas the environmental professionals may pull in a different direction.
The net effect is a decision that has been "shaped" in a manner unique for
that decision and that must be considered by the designer.

Summary
Engineers have a number of tools that can enable them to create socially
and environmentally acceptable designs, including life cycle assessment
and design for recycling. These tools can help to ensure that the
engineering profession continues to grow in its call to protect the public
and the environment.