This document provides an overview of key concepts for interacting with research subjects, including the ethical principles of respect for persons, beneficence, and justice outlined in the Belmont Report. It discusses informed consent as an ongoing process that begins at recruitment, and emphasizes protecting subjects' privacy and maintaining confidentiality of data. The presentation highlights cultural considerations, deviations from protocols, and reporting unanticipated problems.

1. 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.

2. 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).
2

3. 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
3

4. Learning Objectives / 2
• Understand how to help protect participants’
privacy; and
• How to help keep subjects’ study data secure
(confidentiality).
4
Learning Objectives / 2

5. 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.
5

6. 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]
6

7. Nuremberg Code
(1948) “The
voluntary informed
consent of the
human subject is
absolutely
essential.”
Tuskegee Syphilis
Study (1932-72)
Declaration of Helsinki
(1964) “This protocol
should be submitted…to
a specially appointed
ethical review
committee, which must
be independent of the
investigator, the
sponsor or any other
kind of undue
influence.”
National Research
Act (1974)
Research Ethics Highlights

8. 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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9. 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.
9

10. 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)

11. 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.
11

12. 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).
.
12

13. Belmont Ethical Principles:
Justice
• Treat individuals fairly.
• Design research such that its burdens and
benefits are shared equitably.
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14. 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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15. Knowledge Quiz
According to the Belmont Report, what are the three
basic ethical principles upon which the human subjects
protections are based?

16. 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).
16

17. 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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18. 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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19. 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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20. Cultural Considerations / 1
20
‘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/

21. 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).
21

22. 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.
22

23. 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.
23

24. 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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The IC Process / 2

25. 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.
25

26. • 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 / 2

27. 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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28. 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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Tips for the IC Process / 4

29. Knowledge Quiz
T/F: Informed consent is an ongoing process that starts
at recruitment and continues until the end of study
participation.

30. 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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Study Materials

31. 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.

32. 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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33. • 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.
33
Privacy and Confidentiality / 2

34. 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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35. • Avoid scheduling interviews on sensitive
topics in public places.
• Close exam room curtains when conducting
physical exams.
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Protecting Subjects’ Privacy:
Examples / 2

36. 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.
36

37. • 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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Protecting Confidentiality:
Examples / 2

38. 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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39. • 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.
39
Informed Consent, Privacy and
Confidentiality / 2

40. Knowledge Quiz
• How is the concept of privacy and confidentiality
different?
• Give an example of how to protect the
confidentiality of identifiable data?

41. 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.

42. 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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43. • 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.
43
Unanticipated Problems and
Adverse Events / 2

44. 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

45. 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?

46. 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?

47. Thank you for your
attention!
Questions?
June 2016

48. 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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