Regulatory Overview: The Regulations

Applied to
Social and Behavioral Sciences
Content Author:
• Lorna Hicks
Duke University
This module has 7 parts and will require about 20 minutes to complete. Take the short quiz at the
end of the module before proceeding to the next module.
Introduction
Researchers in the social and behavioral sciences and the humanities
often assert that the regulations for the protection of human research
subjects don't really apply to the kind of research that they do,
believing that the rules were written exclusively for biomedical
research. There is a kernel of truth in this because revelations in the
early 1970s about egregious medical experiments provided the
impetus for developing federal standards for protecting human
research.
However, a close reading of the regulations will find mention of
research methods and topics of inquiry relevant for researchers in the
social and behavioral sciences and the humanities. Methods include
surveys, interviews, focus groups, oral history, 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 science, humanities, and behavioral research. For example, the
regulations:
• Identify research activities that are low risk, for example, a survey in which no identifiers
are collected, and that are thus exempt from the remaining provisions of the regulations,
such as the requirement for continuing review.
• Identify research activities with no more than minimal risk that can be 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 protocols. This process can be used effectively
 when it is not possible to know at the outset how a study will evolve, for example when
the study employs community-based participatory research methods.
• Require that IRBs have the necessary competence to review specific research activities.
This module will provide an overview of the federal regulations so that researchers can become
conversant with their basic provisions. The full text of the regulations is available on line. For a
complete discussion about the flexibility in the regulations regarding the consent process, see the
module Informed Consent.
Module Contents
1. Title 45 CFR 46
2. Contents of the Federal Regulations
3. What must be reviewed?
4. Expedited or full review?
5. Who must review research with human subjects?
6. What questions must be addressed during a review?
7. Reviews throughout the life of a project
8. Other issues

1.0 Title 45 Code of Federal Regulations Part 46: Protection

of Human Subjects
The Department of Health and Human Services (DHHS) regulations are sometimes referred to
as 45 CFR 46, a label that identifies their location in the Code of Federal Regulations. You will
probably see 45 CFR 46 quoted in your institution's policies and resource materials.
Subpart A of 45 CFR 46 is often referred to as the "Common Rule." Although these regulations
were first drafted and adopted by DHHS, most departments that fund research in the social and
behavioral sciences, including the National Science Foundation and the Department of
Education, subsequently adopted the regulations, thus the designation "Common Rule."
Additional Protections for Vulnerable Subjects
Three subparts have been added to the basic provisions, Subpart A, of
the federal regulations:
1. Subpart B: Pregnant women, fetuses, and neonates
2. Subpart C: Prisoners
3. Subpart D: Children
Note: The additional protections for prisoners and children are
covered in Modules 7 and 8, respectively, and will not be discussed
here. The additional protections for pregnant women, fetuses, and
neonates are most relevant in biomedical research.
It should be noted that some federal agencies that adopted the
Common Rule have also adopted some or all of the other subparts of
the DHHS regulations, but others have not. For example, while the
Department of Education has adopted the additional protections for children, the National
Science Foundation has not.
Assurances with the Office of Human Research Protections
Every institution conducting research with federal support is required to enter into an agreement
called an "assurance."� Most assurances are negotiated with the DHHS Office of Human
Research Protections (OHRP).� An assurance identifies the regulations for protecting research
subjects that the institution will follow and the ethical principles it will adopt. In the United
States these are the Common Rule and the Belmont Report. �The assurance also states how
broadly the institution will apply the Common Rule and the additional subparts. Some
institutions apply the Rule to all research regardless of the source of funding. This means that the
Rule would apply to research funded by foundations, associations, internal award programs, all
other sources of research support, and when research is not funded. Some institutions also
choose to apply the additional subparts, B, C, and D, to all research regardless of the source of
funding. Others choose to apply the subparts only to federally funded research.

2.0 Content of the Federal Regulations

The federal regulations for protecting

research subjects describe:
• What research must be
reviewed,
• Who must review it,
• What questions should be
addressed during a review,
and
• What kinds of review need to take place during the life 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.
3.0 What Must Be Reviewed
The first step in deciding whether a project needs review is to determine whether it meets the
definition of research with human subjects. If it doesn't meet the definition, it doesn't require
review by an IRB, although there may be ethical issues that must be addressed by the
researcher's institution.
See the module Defining Research with Human Subjects for a discussion about how to apply the
following definitions:
Research means a systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.
Human subject means a living individual about whom an investigator (whether professional or
student) conducting research obtains
1. Data through intervention or interaction with the individual, or
 2. Identifiable private information.
Once it has been determined that a project meets the definition of research with human subjects,
the next step is to determine the type of review it needs. The type of review determines who will
conduct the review.

Research Eligible for Exemption

Of significant interest to social and behavioral scientists is the fact that there are activities that
do meet the definition of research with human subjects but are not covered by the provisions of
the Common Rule. Thus they do not require review as described in the Rule.
While these studies do not require review in accordance with the Rule, some procedure is
necessary to make the determination that they are eligible for exemption. Institutional
procedures vary, but the common element is that the institution, not the investigator must make
the determination.

Research may be eligible for exemption from the Common Rule if all the activities associated
with the research fall into one or more of six categories. Of the six categories, three are
frequently used by social and behavioral scientists. They are:
1. Research conducted in established or commonly accepted educational settings, involving
normal educational practices.
2. Research involving survey procedures, interview procedures, or observation of public
behavior providing that 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.

NOTE: If Subpart D applies, either by sponsor requirement or institutional choice, the

following activities with children cannot be exempt: interviews, surveys, and participant
observation.

3. Research involving the collection or study of existing data (collected prior to the research
for purposes other than the research) if the data
are publicly available or recorded by the
investigator in such a manner that the subjects
cannot be identified.
A complete list of research activities eligible for
exemption is provided at 45 CFR 46.101.
4.0 Expedited or Full Review

If research is not eligible for exemption, the remaining

options are expedited or full review.
To be eligible for expedited review research must meet
two criteria:
1. Pose no more than minimal risk to subjects.
 "No more than minimal risk" means that "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."
2. Consist only of one or more research activities specified in the regulations as eligible for
expedited review.

Eligible activities are similar to those for exempt research (some surveys, interviews, and
data analysis) with the addition of some minor or non-invasive medical procedures, such
as blood pressure readings, weight measurements, and blood draws that are used
occasionally by researchers in the social and behavioral sciences.

The preamble to the list of specified activities notes that 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.
Institutional policy, local conditions, and subject vulnerability may require review by a
convened Institutional Review Board (IRB) even for a study with no more than minimal risk,
such as a study of decisionally-impaired individuals. 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.

5.0 Who Must Review Research with Human Subjects

As prescribed in the regulations and implemented by institutional policy there are three possible
sets of reviewers:
1. Staff or IRB members identified by the institution to screen research for exempt status.
2. One or more IRB members conducting expedited reviews.
3. Members of a convened IRB for studies requiring full review.
Description of an Institutional Review Board
An Institutional Review Board 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.
Membership
The minimum size and required composition of an IRB is spelled out in detail in the regulations.
An IRB must have at least five members. Its membership must be diverse including
considerations of race, gender, and cultural background. The committee is expected to be
sensitive to community attitudes; have knowledge and experience with vulnerable populations;
and to 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 research. 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 is to review 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 Institutional Review Board

Federal regulations stipulate that an IRB

can:
• Approve research.
• Disapprove research.
• Require modifications to proposed
research.
• Conduct continuing reviews.
• Observe/verify changes.
• Suspend or terminate approval.
• Observe the consent process and
the research procedures.
The regulations also require that IRBs develop procedures for handling noncompliance.

Other Institutional Reviews

Research approved by an IRB may be subject to further review and approval or disapproval by
officials of the institution (for example, department heads, deans, research directors). However,
if an IRB has disapproved the research, the institution cannot override that determination.
6.0 What Questions Must 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
and full review would not apply. However, all research should
abide by the three basic ethical principles elucidated in the
Belmont Report: respect for persons, beneficence, and justice.
Thus, for example, the principle of respect for persons would
entail securing informed consent from research subjects.
Therefore, many institutions have developed forms designed to
gather sufficient information to determine not only that a
project is exempt, but that it is being conducted in accordance
with basic ethical principles.
Review Criteria for Expedited and Full Review

IRB members who are conducting an expedited review, or the

convened IRB conducting a full review, must ask the following questions:
1. Have the risks to subjects been minimized using procedures that are consistent with
sound research design?
2. Are the risks reasonable in relation to anticipated benefits?
3. Is the selection of subjects equitable?
4. Are adequate procedures in place to ensure privacy and confidentiality?
5. Is there a plan to monitor the data and safety of the subjects, if necessary?
6. Will informed consent be sought and appropriately documented? Do proposed alterations
or waivers of informed consent meet the criteria for approval?
7. Are safeguards in place to protect vulnerable populations?
Comparison of Expedited and Full Review
Review procedures for expedited review and full review are similar in several ways:
• The review criteria are the same.
• Both types of review are documented communication processes between investigators
and reviewers.
• Expediting reviewers and the full IRB can request modifications to submissions and can
approve protocols, continuing reviews, and amendments to approved protocols.
• Expediting reviewers and the IRB will specify when a protocol must be reviewed again.
By regulation it must be within twelve months, but shorter review periods may be
required.
A key difference between the two processes is that expedited reviewers cannot disapprove a
protocol. They must refer protocols they cannot approve to the full IRB. All IRB members must
be advised about protocols, continuing reviews, and amendments approved through expedited
review procedures. Any member of the IRB may request that such approvals be reconsidered by
the full IRB.

7.0 Reviews throughout the Life of a Project

Once a protocol has received initial approval through expedited or full review procedures, it
must be reviewed, according to procedures described in the Common Rule, within twelve
months of its approval date. In addition, changes to
approved protocols must be approved prior to
implementation, and reports of unanticipated
problems must be reviewed.
Continuing Review: Expedited or Full?

Federal regulations permit expedited review to be

used for continuing review if the initial review was
expedited and no new risks were identified. It may
also be used when the initial review was conducted
by a full IRB under some circumstances, such as 1)
when no additional risks have been identified and during the initial review the IRB determined
and documented that the research involves no greater than minimal risk, or 2) the remaining
activities are limited to data analysis.
The IRB or the expediting reviewer(s) must determine that all the requirements for initial review
continue to be satisfied.
The Common Rule also requires that continuing review cover specific information, including the
number of subjects accrued, a summary of any relevant recent literature, a description of any
unanticipated problems, and a copy of the current consent form.
Follow the link to the view the latest Guidance from the OHRP on Continuing Review.
Amending Approved Protocols
Changes to approved protocols must be approved prior to their implementation. The regulations
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."
Consult with your IRB about your institution's policies and procedures regarding these reviews
and about what constitutes a "minor" change.
Proposed changes to exempt research must be reviewed in some manner to ensure that the
revised research still meets the criteria for exemption.
Reports of Unanticipated Risks or Harms
Institutions conducting research under the auspices of an assurance with OHRP are required to
develop written procedures for reporting and reviewing unanticipated problems involving risks
or harms to research subjects.
8.0 Other Issues
The regulations cover other issues not addressed in this module such as working with
collaborators, both domestic and international, required record keeping, and suspension and
termination of IRB approved research.
Revised August 28, 2008
Posted August 28, 2008