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User Studies and the IRB: Ethical and Regulatory Considerations

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Title: User Studies and the IRB: Ethical and Regulatory Considerations


1
User Studies and the IRB Ethical and Regulatory
Considerations
  • Mary C. Whitton
  • Graphics Lunch 15 January 2003

2
Overview
  • What is the IRB and why is it?
  • What ethical issues arise in user studies?
  • When do the regulations apply?
  • How to apply for IRB approval
  • risks to participants
  • informed consent

3
History, 1
  • People have been treated badly in the name of
    scientific research
  • Nazi medical experiments
  • Tuskegee Syphilis Study (1930s-1972)
  • Human Radiation Studies (1944-1974)
  • 1948 UN resolution (post WWII)
  • 1953 first US policies (NIH)
  • Independent review of planned studies
  • NIH compliance offices till 2000

4
History, 2
  • 1974 congressional hearings
  • DHEW required to create policies
  • Commission on Protection of Human Subjects
  • 1979 The Belmont Report
  • Ethical Principles and Guidelines for the
    Protection of Human Subjects in Research
  • 1991 The Common Rule
  • Unified policies across federal agencies
  • 2000 Office of Human Research Protections

5
Why emphasize protection?
  • Promote safety and well being of participants
  • Maintain ethical foundations of research
  • Perform scientifically valid research
  • Allay concerns of general public

6
What regulations?
  • Code of Federal Regulations
  • Title 45,Part 46 (45CFR46)
  • Subpart A The Common Rule
  • Federal Policy for the Protection of Human
    Subjects
  • Applies to research in all federal agencies

7
The Enforcers
  • Office of Human Research Protections
  • Within Department of Health and Human Services
  • Job 1 protect human participants
  • Job 2 supervise IRBs
  • They have a big stick
  • Human subject studies can be shut down
  • Johns Hopkins, Duke

8
What is the IRB ?
  • Institutional Review Board
  • Review, provide advice, and approve
  • Institutional level oversight
  • 5 UNC IRBs
  • Academic Affairs (CS falls here)
  • Medicine, Dental, Nursing, Public Health

9
Guiding Principles
  • Respect for Persons (autonomy)
  • Beneficence
  • Justice

10
Guiding Principles
  • Respect for Persons (autonomy)
  • …capable of deliberation..and of acting under
    such deliberation. (informed consent)
  • Additional protections for those with diminished
    autonomy, e.g. children, developmental disorders
  • Beneficence
  • Justice

11
Respect for persons
  • Terminology
  • New term participants
  • Old term subjects
  • Pressure to participate
  • Incomplete disclosure of risks
  • Must we reveal that one person had VE
    after-effects that lasted 6 months?
  • Reveal to IRB? Reveal to participants?
  • Respect for cultures
  • Case in NCSU Research Ethics Module

12
Guiding Principles
  • Respect for Persons (autonomy)
  • Beneficence
  • Maximize possible benefits
  • Minimize possible harm
  • Balance of benefits and risks for individual
  • Balance of societal good and participant risk
  • Justice

13
Beneficence Case
  • A study has shown that expensive drug A
    effectively prevents a certain life-threatening
    condition in pregnant women.
  • Researchers have found that a cheap, common, and
    safe food supplement has the same effect.
  • Can they ethically perform a double blind study
    with placebos to get FDA approval for the food
    supplement solution?

14
Guiding Principles
  • Respect for Persons (autonomy)
  • Beneficence
  • Justice
  • Who should bear the risks?
  • Who should get the benefits?
  • Fair and unbiased selection
  • participants
  • beneficiaries

15
Justice
  • Now required to include women and children in
    studies
  • Cant study a convenient population if they are
    not subject to the problem
  • E.g. people in mental hospitals, prisoners
  • Cant exclude participants for reasons not
    relevant to study
  • E.g. sex, age, race, socio-economic status

16
Why emphasize protection?
  • Promote safety and well being of participants
  • Maintain ethical foundations of research
  • Perform scientifically valid research
  • Allay concerns of general public
  • Respect for person (autonomy) Beneficence
  • Justice

17
Regulations
  • When regulations apply
  • Experimenter training
  • Applying for approval

18
Is it research?
  • Research is a systematic investigation …
    designed to discover or contribute to a body of
    generalizable knowledge. 
  • Not all research involves human participants,
    but when they are involved, researchers and their
    teams are legally and ethically obligated to
    protect them.
  • From NIH training

19
Is it human subject research?
Guidance from OHRP
20
Exempt studies w/ humans
  • Educational (classroom) strategies
  • Use of educational tests
  • (Re) study of existing data with no
    identification of participants
  • Study, evaluate public benefit programs
  • Taste and food quality evaluation (if
    consumption is otherwise safe)

21
Getting Permission
  • Human Participant Protection Training
  • The IRB Process
  • The IRB Request for Review
  • Forms
  • Risks and Risk Management
  • Informed Consent

22
Experimenter Training
  • Required for experimenters who
  • Design and execute studies
  • Write the IRB request for review
  • Collect and/or analyze data
  • Solicit the informed consent
  • Not required for
  • Cable carriers, etc.

23
NIH online training
  • 1 hour
  • http//cme.nci.nih.gov/
  • History
  • The Basics (who, when, why?)
  • Informed Consent
  • IRB Review
  • Ongoing Protection
  • International Research

24
IRB Process
  • Experimenter completes IRB request for review
  • Local review CS Dept.
  • Our job send approvable proposals to AA-IRB
  • Whitton, Quigg, Student Dennis Jen
  • AA-IRB review approval
  • Annual renewal
  • Final report

25
AA-IRB
  • Chair Barbara Goldman, PhD
  • Admin Joyce Hamlett
  • Rapid email responses
  • 6th floor, BoA Center
  • Board of 15 members
  • 2-3 community/non-scientific members
  • Meet monthly

26
The IRB is your friend
  • Participant safety is their full-time job
  • Theyre trained to think about sources of harm
  • They know ways to protect from harm
  • They protect you and UNC
  • Dr. Goldman is very reasonable
  • SIGGRAPH study approval was easy

27
Expedited vs Full Review
  • Expedited review available for certain types of
    studies
  • VE qualifies as human factors evaluation
  • PI recommends expedited review
  • Local review committee approves
  • AA-IRB Chair approves
  • Does not go to full board review
  • 90 of AA-IRB reviews are expedited

28
Request for Review
  • (go to web pages)

29
Risks and Risk Management
  • Full disclosure of risks
  • What is dangerous?
  • How dangerous is it?
  • Are there alternatives to doing this?(medical)
  • Is it minimal risk or not?
  • How does it compare to everyday activity?
  • Details of how control risks
  • Precautions, safeguards

30
Risks VE case
  • RISKS
  • Can trip over things in the dark
  • May get nauseous
  • Rare incidence of after-effects
  • RISK MANAGEMENT
  • Experimenter stays close enough to catch
  • Experimenter will watch for sweating and swaying
    stop if observe or requested
  • Information provided to participant on what to do
    if after effects occur at different severity
    levels

31
IRB and risk
  • Are risks being minimized?
  • Is risk to participant minimal, or not?
  • If minimal risk, may qualify for expedited review
  • If more than minimal risk, is risk worth the
    benefit? (Beneficence guideline)

32
Informed Consent Process
  • Autonomy Principle Individual is able and has
    the right to make decisions about what she/he
    does.
  • Experimenter must
  • Convey accurate information
  • Purpose of study (deception?)
  • Risks, benefits, procedures
  • Answer questions from participant
  • Allow participant to make decision

33
Elements of Informed Consent
  • Participant is competent to decide
  • Full disclosure made by researcher
  • Participant comprehends information
  • Participant agrees to participate
  • Agreement is voluntary and free from coercion
  • Participants allowed to withdraw at any time
    without penalty
  • Interaction with participant while obtaining
    consent is important

34
Informed Consent Documents
  • Most important part of the IRB package your
    contract with participant
  • Highly dependent on study specifics
  • Level of risk
  • Expected educational level of participants
  • Good samples on web
  • Participant recruiting documents are part of the
    informed consent

35
Request for Review
  • Cover Sheet
  • Proposal Form with signatures
  • Proposal Text
  • Informed consent document
  • Recruiting documents (flyers, email)
  • Copies of data collection instruments
  • Verification of Human Participants Protection
    Training for all experimenters
  • Give IRB all the information they need to approve
    your study

36
Resources
  • CS IRB Local Review Whitton, Quigg
  • Students who have done studies
  • UNC Research web site
  • http//research.unc.edu/services/human_sub.html
  • AA-IRB web site, manual, personnel
  • http//research.unc.edu/gsr/aairb.html
  • http//research.unc.edu/gsr/irb/index.html
  • NIH training web site
  • http//cme.nci.nih.gov/
  • NCSU Research Ethics Module
  • http//fis.ncsu.edu/Grad/ethics/modules

37
More information
  • Research Administration Course Session
  • February 28 (Friday), 10 AM, Sitterson 011
  • Introduction To Compliance
  • Human and Animal Protection
  • Informed Consent
  • IRBs/IACUCs (Institutional Animal Care and Use
    Committee)

38
Guiding Principles
  • Respect for Persons (autonomy)
  • Beneficence
  • Justice

39
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40
Human Subjects in Grants
  • If you plan studies, must include section on
    human subjects in the proposal
  • NIH resources Instructions for grants
  • http//grants2.nih.gov/grants/funding/phs398/phs39
    8.html
  • Human Subjects Research Section
  • Additional requirement for a Safety Plan

41
(No Transcript)
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