Working With Research

Study Participants:
An Overview
Office for Protection of Human Subjects /
Committee for Protection of Human Subjects
University of California, Berkeley
ophs@Berkeley.edu / (510) 642-7461

March 2020; V.3.

Interacting with Research Subjects
An overview on how to:
•Share information about a research study with
potential subjects who may volunteer for the
study; and
•Interact with subjects throughout the study
(e.g., conducting the informed consent process,
administering surveys, interviewing, leading
focus groups).

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Learning Objectives / 1
After this presentation, you should be
able to:

•Name and understand the three basic ethical principles

described in The Belmont Report;

•Implement these ethical principles when working with

research subjects,
- including research in international settings

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Learning Objectives / 2
Learning Objectives / 2
• Understand how to help protect participants’
privacy; and

• How to help keep subjects’ study data secure

(confidentiality).

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The Research Team / 1
• Our ethical responsibility is to protect the study
subjects.

• Thorough training in how to recruit and interact

with subjects, conduct the study procedures, and
maintain effective communications are all key to
the process.

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The Research Team / 2

•Each team member should understand his/her

role in the study.

•All questions about the study—now or later—

should be directed to [name UC Berkeley PI or
designee]

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Research Ethics Highlights
Nuremberg Code Declaration of Helsinki
(1964) “This protocol
(1948) “The should be submitted…to a
voluntary informed specially appointed ethical
consent of the review committee, which
human subject is must be independent of
the investigator, the
absolutely sponsor or any other kind
essential.” of undue influence.”

Tuskegee Syphilis National Research

Study (1932-72) Act (1974)
The Belmont Report

• The Belmont Report identifies the ethical principles upon which

the federal regulations for human subject protections are based.

 Respect for persons

 Beneficence
 Justice

• Reading this short document is highly recommended; see

“Additional Resources” (final slide).

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Belmont Ethical Principles:
Respect for Persons / 1
• The autonomy of the individual must be
acknowledged and respected.

– Informed consent.

– Voluntariness – ability to decide to participate in

research and to withdraw at any time, without
coercion or undue influence from others.

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Belmont Ethical Principles:
Respect for Persons / 2
• Individuals with limited autonomy must
receive additional protections. The limits

– May be inherent (e.g., limited capacity to

understand and process information).

– May be situational (e.g., prisoners, children, and

pregnant women and fetus/neonates)
Belmont Ethical Principles:
Beneficence / 1
• Researchers’ obligation to endeavor to “do no
harm,” minimize any risks and maximize any
benefits of the research.

– Use procedures that are the least risky.

– Risks – include physical, psychological, legal, social

and economic harms.

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Belmont Ethical Principles:
Beneficence / 2

• Benefits may be

– To individual subjects; and/or

– To others (e.g., to basic research, to a community,

or to society as a whole).

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Belmont Ethical Principles:
Justice

• Treat individuals fairly.

• Design research such that its burdens and

benefits are shared equitably.

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Informed Consent
• Informed Consent (IC) is often misinterpreted
as merely obtaining an individual’s signature
on a form (or a “yes” response in a verbal
consent process.

• Actually, IC is a process of education and

decision-making that begins with the very first
contact with a potential study subject (i.e.,
during recruitment).

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Knowledge Quiz
According to the Belmont Report, what are the three
basic ethical principles upon which the human subjects
protections are based?
IC – Begins with Recruitment / 1
Study staff who recruit subjects should keep in
mind that this step is also part of the IC process.

– While initial information shared with potential

subjects will be briefer than what is contained in
the IC document, care should be taken during
initial contacts to provide only accurate information
(i.e., consistent with the IC documents/study
procedures).

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IC – Begins with Recruitment / 2
Regulations permit initial discussions about the study to
occur in a group setting or one-on-one. A setting can be
selected for reasons that are practical or based on
cultural considerations.

–When recruiting in group settings (e.g.,

informational meeting, classroom) make sure that
there’s a way for subjects to raise questions/agree to
participate in private (i.e., not in front of
colleagues/classmates, etc.) Be sure to notify potential
subjects of this option.

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The IC Process
• For those individuals who decide to
participate, the IC process continues
throughout the study.

– It is an ongoing dialog that includes providing new

information (e.g., changes in risk factors) that may
impact the decision to continue in a study.

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Goals of the IC Process
To build with each potential/enrolled subject:

•A trusting relationship and open dialog.

•An understanding of the essence of a study so

that s/he can make a truly informed,
autonomous decision about whether to
participate.

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Cultural Considerations / 1

‘Iceberg model’ of culture developed by Selfridge and Sokolik, 1975 and W.L. French
and C.H. Bell in 1979, https://zestnzen.wordpress.com/2012/01/26/how-to-
understand-cross-cultural-communication/

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Cultural Considerations / 2
• Key factors:

– Trying to remain aware of our own biases.

– Educating ourselves and asking for help.

– Being sensitive to and curious about cultural

differences (i.e., asking, not assuming).

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From the Outset, Potential/
Enrolled Subjects Need to Know:

•The study constitutes “research.”

•It is entirely up to them whether they participate or

not.

•They are free to skip questions (e.g., during an

interview), or stop participating in the study at any time
without having to share their reason(s) for doing so.

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The Informed Consent (IC)
Process / 1

People approach volunteering for a study with

preconceived ideas and life issues that may
impede true informed consent. It is the
research team’s responsibility to identify and
address these issues as part of the IC process.

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The IC Process / 2

Some potential subjects may adopt a “Give me

the form, I’ll just sign it” approach. However,
the key points about a study should always be
reviewed as part of the process.

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Tips for the IC Process / 1

IC discussions should take place in a quiet,

private location. If IC occurs via phone, check to
see if it’s a good time for the person to talk, and
if s/he is in an appropriate location.

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Tips for the IC Process / 2
• Some potential subjects may be reticent about
asking questions (e.g., shy, do not want to
appear “dumb,” etc.)

• Avoid passive acceptance when a potential

subject states s/he has no questions. To
facilitate understanding, encourage a subject
to repeat—in his/her own words—the key
points about a study.

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Tips for the IC Process / 3

• If a potential subject seems stressed or

anxious, it will likely be hard for him/her to
assimilate the IC information.

–Consider offering to reschedule the discussion.

–If the individual wishes to go ahead, slow things

down by going point-by-point, encouraging his/her
input, and/or summarizing the responses.

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Tips for the IC Process / 4

In general, encourage potential subjects to take

their time (e.g., ask questions, take the form
home, talk to friends/family, etc.)

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Knowledge Quiz
T/F: Informed consent is an ongoing process that starts
at recruitment and continues until the end of study
participation.
Study Materials
Staff who recruit or work with study participants should
verify with the PI/designee that only the most recent
IRB-approved materials --e.g., flyers, phone
recruitment scripts, interview consent documents,
surveys/questionnaires, or debriefings—are being used.

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Tips on Data Collection
• Follow study instructions (e.g., study SOP) for completing
surveys/questionnaires/interviews.
• Do ask the questions as intended in the research.
• Don’t rephrase or shorten the questions to save time.
• Be mindful that participants are free to skip questions or
stop participation in the study at any time.
• Record the responses completely and accurately.
• Extraneous information that is not included in the survey
or questionnaire should not be collected/recorded.
Privacy and Confidentiality / 1
These terms are sometimes confused.

•Privacy pertains to control over the extent,

timing, and circumstances of sharing oneself
(physically, behaviorally, or intellectually) with
others.

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Privacy and Confidentiality / 2

•Confidentiality pertains to the treatment of

information that an individual discloses in a
relationship of trust. It involves the expectation that
information will not be divulged to others-- without
permission--in ways that are inconsistent with the
understanding of the original disclosure.

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Protecting Subjects’ Privacy:
Examples / 1

• When an individual other than the subject answers the

phone, ask for subject by name but withhold the
context (e.g., do not share that the call is about a
research study; do not name study, etc.)

• Be sensitive to privacy issues when leaving voice mail

messages. Check with the subject to see if it is okay to
leave messages.

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Protecting Subjects’ Privacy:
Examples / 2

•Avoid scheduling interviews on sensitive topics

in public places.

•Close exam room curtains when conducting

physical exams.

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Protecting Confidentiality: Examples / 1
• Share subject study data only with appropriate
study team members.

• Keep signed consent forms and other documents

containing identifiable data in a secured location.

• Encrypt and password-protect all identifiable data

files – including all audio and/or video recordings.

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Protecting Confidentiality:
Examples / 2
•Keep memory sticks, laptops and other removable media
secured when not in use.

•Keep participant names/study identification codes in a

separate, secure location from all other study data.

•Additional confidentiality measures may also apply when

studies are subject to the EU General Data Protection
Regulation (GDPR), and other countries with their own
data protection requirements.

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Informed Consent, Privacy and
Confidentiality / 1
• The study consent documents provide an
explanation of the extent to which the
confidentiality of private data identifying
subjects will be maintained.

• Familiarize yourself with the study consent

documents and our study team data security
plan. Apply these standards in your day-to-day
work.

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Informed Consent, Privacy and
Confidentiality / 2
• An unintended breach of confidentiality is a risk
factor for any research study.

• Since complete confidentiality of research data

cannot be guaranteed, avoid any wording that
implies such assurance.

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Knowledge Quiz
• How is the concept of privacy and confidentiality
different?

• Give an example of how to protect the

confidentiality of identifiable data?
Deviations from Study Procedures
• Instances when IRB approved study procedures are
not followed:
- inadvertent mistake
- sometimes necessary to deviate in order to
protect participants

• All protocol deviations and non-compliances must be

promptly reported to the UCB PI/designee and to
CPHS.
Unanticipated Problems and
Adverse Events / 1

•Despite a study team’s best efforts, unanticipated

problems (e.g., a confidentiality breach; using an
outdated version of a study questionnaire; person
faints during a blood draw) do happen.

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Unanticipated Problems and
Adverse Events / 2
• It is very important that study team members
report any unanticipated problem or adverse event
as soon as possible to [name UC Berkeley PI or
designee].

• The PI assumes overall responsibility for the study.

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Research in International Setting /
1
When HHS-supported research takes place outside of
the United States questions about fair treatment and
fair standards may arise. This may be especially true of
research conducted in countries where:
• Resources may be scarce and/or
• Other vulnerabilities may be pronounced
Research in International Setting / 2
A few of the many issues that demand careful consideration with
respect to justice, as well as beneficence and respect for persons,
include:
•How can research conducted in resource-poor setting avoid exploiting
participants?
•What is owed to participants in clinical research and to the
population of the host country after studies are complete?
•In addition to following the HHS regulations, what standards and
assurances to protect research participants should investigators and
non-US institutions use when conducting research abroad?
•How can regional or cultural differences be negotiated?
•For settings where cultural values impact informed consent, how
should processes be altered?
Knowledge Quiz
1. T/F: Vulnerable subject populations do not have special protections
under the federal regulations (45 CFR 46 Subparts B, C, D).

2. “Do No Harm” is part of which Belmont Ethical Principle?

3. T/F: Study staff must only use IRB-approved study documents to

obtain informed consent and conduct study procedures.

4. Conducting interviews in a discreet location is an example of

________ protection.

5. When a deviation from the protocol or an unanticipated problem has

occurred, when and to whom do you report the event?
 Thank you for your
attention!
Questions?

June 2016
Additional Resources
• The Belmont Report
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

• CPHS Data Security Guidelines & Matrix

https://cphs.berkeley.edu/datasecurity.pdf

• CPHS Reporting Unanticipated Problems & Adverse Events

https://cphs.berkeley.edu/unanticipated_problems_adverse_events.pdf

• Human Subjects Research Training Guide for International Enumerators

https://cuhs.harvard.edu/files/cuhs/files/enumerator_training_-_irb.pdf

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