User Studies and the IRB: Ethical and Regulatory Considerations

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User Studies and the IRBEthical and Regulatory
Considerations

• Mary C. Whitton
• Graphics Lunch15 January 2003

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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

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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

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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

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Why emphasize protection?

• Promote safety and well being of participants
• Maintain ethical foundations of research
• Perform scientifically valid research
• Allay concerns of general public

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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

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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

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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

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Guiding Principles

• Respect for Persons (autonomy)
• Beneficence
• Justice

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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

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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

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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

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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?

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Guiding Principles

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

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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

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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

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Regulations

• When regulations apply
• Experimenter training
• Applying for approval

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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

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Is it human subject research?
Guidance from OHRP
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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)

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Getting Permission

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

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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.

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NIH online training

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

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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

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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

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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

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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

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Request for Review

• (go to web pages)

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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

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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

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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)

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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

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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

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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

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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

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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

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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)

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Guiding Principles

• Respect for Persons (autonomy)
• Beneficence
• Justice

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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

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