Title: Working With Research Study Participants: An Overview
1Working With Research Study Participants An
Overview
Office for Protection of Human Subjects
/ Committee for Protection of Human
Subjects University of California,
Berkeley ophs_at_Berkeley.edu / (510) 642-7461
August 2016 V.1.
2Interacting 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).
3Learning 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. -
4Learning Objectives / 2
Learning Objectives / 2
- Understand how to help protect participants
privacy and - How to help keep subjects study data secure
(confidentiality).
5The 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.
6The Research Team / 2
- Each team member should understand his/her role
in the study. - All questions about the studynow or latershould
be directed to name UC Berkeley PI or designee
7The Belmont Report
- The Belmont Report identifies the ethical
principles upon which the federal regulations for
human subject protections are based. - Reading this short document is highly
recommended see Additional Resources (final
slide).
8Belmont 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.
9Belmont Ethical PrinciplesRespect for Persons /
2
- Individuals with limited autonomy must receive
special protections. The limits - May be inherent (e.g., limited capacity to
understand and process information). - May be situational (e.g., prisoners, children)
10Belmont 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.
11Belmont 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). - .
12Belmont Ethical Principles Justice
- Treat individuals fairly.
- Design research such that its burdens and
benefits are shared equitably.
13Study Materials / 1
- 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 and debriefingsare being used.
14Study Materials / 2
Study Materials / 2
- Design research such that its burdens and
benefits are shared equitably. Any changes to
flyers, phone recruitment scripts, interview
consent documents, debriefings and other study
materials must be approved by the IRB via
protocol amendment before being used with
research participants.
15Informed Consent
- Informed Consent (IC) is often misinterpreted as
merely obtaining an individuals 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).
16IC Begins with Recruitment / 1 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).
17IC 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
theres 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.
-
18The 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.
19Goals 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.
20Cultural Considerations / 1
21Cultural 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).
22From 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.
23The 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
teams responsibility to identify and address
these issues as part of the IC process.
24The IC Process / 2
- Some potential subjects may adopt a Give me the
form, Ill just sign it approach. However, the
key points about a study should always be
reviewed as part of the process.
25Tips for the IC Process / 1
- IC discussions should take place in a quiet,
private location. If IC occurs via phone, check
to see if its a good time for the person to
talk, and if s/he is in an appropriate location.
26Tips 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 repeatin
his/her own wordsthe key points about a study.
27Tips 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. -
28Tips 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.)
29Privacy 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.
30Privacy 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.
31Protecting 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. -
32Protecting Subjects Privacy Examples / 2
- Avoid scheduling interviews on sensitive topics
in public places. -
- Close exam room curtains when conducting physical
exams.
33Protecting 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.
34Protecting 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.
35Informed 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.
36Informed Consent, Privacy andConfidentiality / 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.
37Unanticipated Problems and Adverse Events / 1
- Despite a study teams 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.
38Unanticipated 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.
39Thank you for your attention!
June 2016
40Additional Resources / 1
- The Belmont Report http//www.hhs.gov/ohrp/regula
tions-and-policy/belmont-report/ - NIH Office of Extramural Research History of
human subjects protections includes a timeline
of key events http//phrp.nihtraining.com/history
/07_history.php -
41Additional Resources / 2
- CPHS Data Security Guidelines Matrix
http//cphs.berkeley.edu/datasecurity.pdf