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Working With Research Study Participants: An Overview

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Title: Human Subject Research Author: Howard N. Zelaznik Last modified by: Diana W Holt, MS Created Date: 2/25/2000 1:02:11 PM Document presentation format – PowerPoint PPT presentation

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Title: Working With Research Study Participants: An Overview


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_at_Berkeley.edu / (510) 642-7461
August 2016 V.1.
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).

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.

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

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.

6
The 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

7
The 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).

8
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
Belmont 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)

10
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
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
Belmont Ethical Principles Justice
  • Treat individuals fairly.
  • Design research such that its burdens and
    benefits are shared equitably.

13
Study 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.

14
Study 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.

15
Informed 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).

16
IC 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).

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
    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.

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.

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.

20
Cultural Considerations / 1
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).

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.

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
    teams responsibility to identify and address
    these issues as part of the IC process.

24
The 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.

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 its a good time for the person to
    talk, and if s/he is in an appropriate location.

26
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 repeatin
    his/her own wordsthe key points about a study.

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.

28
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.)

29
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.

30
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.

31
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.

32
Protecting Subjects Privacy Examples / 2
  • Avoid scheduling interviews on sensitive topics
    in public places.
  • Close exam room curtains when conducting physical
    exams.

33
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.

34
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.

35
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.

36
Informed 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.

37
Unanticipated 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.

38
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.

39
Thank you for your attention!
  • Questions?

June 2016
40
Additional 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

41
Additional Resources / 2
  • CPHS Data Security Guidelines Matrix
    http//cphs.berkeley.edu/datasecurity.pdf
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