Research Ethics in the Social Sciences

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Research Ethics in theSocial Sciences
Humanities

• Dean Sharpe, Ph.D.
• Office of Research Ethics
• University of Toronto
• September, 2008

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Outline

• Research ethics framework culture
• Proportionate review risk
• Preparing a protocol research ethics issues

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History

• Nuremberg Code (1947)
• WWII crimes against humanity
• Declaration of Helsinki (1964)
• World Medical Association, drug trials
• Belmont Report/Common Rule (1979)
• Research scandals (e.g., Tuskegee syphilis study)
• Tri-council Policy Statement (1998) MOUs
• Canadian research council guidelines

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Key Ideas

• Key principles and issues
• Respect for human dignity, autonomy
• Balance distribution of harms/benefits
• Free informed consent
• Privacy confidentiality
• Conflict of Interest
• Inclusion/exclusion criteria
• System of research participant protection
• Prior review of protocols
• Office of Research Ethics (ORE) Research Ethics
  Boards (REBs)

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REBs

• Quorum
• 5 members, women men
• 2 broad knowledge of methods or areas
• 1 knowledgeable in ethics
• 1 no affiliation with the institution
• 1 knowledgeable in relevant law (biomed research)
• University of Toronto 2 boards
• Social Sciences, Humanities Education (
  management, law, engineering, . . .)
• Health Sciences

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Research Ethics Culture at UTIntegral Part of
Scholarly Process

• Research ethics at its best when understood to be
  part of scholarly process . . . not about
  authority
• The same tri-council that funds research is the
  same tri-council that requires research ethics
  review
• Researchers should budget for it, have models on
  hand, supervise studentsmake part of the
  scholarly process
• Reviews should be principles based, tightly
  reasoned
• Have to get beyond idea that excellence in
  research excellence in research ethics somehow
  incompatible
• Should be self-evident they go hand in hand

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Research Ethics Culture at UTDedicated Board
for SSH

• Myth that research ethics fixated on biomedical
  model
• UT has a board dedicated to social sciences
  humanities
• Researchers from Psychology, Anthropology,
  Sociology, Political Science, Management review
  Psychology, Anthropology, Sociology, Political
  Science, Management . . .
• no over-weaning interest in or sympathy for
  biomedical model

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Research Ethics ReviewProportionate Approach

• Exempt
• educational testing, program evaluation
• Undergrad
• Delegated Ethics Review Committees (DERCs)
• Expeditable
• minimal risk on par with daily lifebut see
  risk matrix
• Non-expeditable
• full REBsee risk matrix
• Continuing review
• annual renewal, study completion, chance of site
  visit

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Proportionate Review Risk

• Group vulnerability diminished autonomy . . .
  Informed? Free?
• Physiological (e.g., health crisis, service
  dependence)
• Cognitive/emotional (e.g., age, capacity, recent
  trauma)
• Social (e.g., stigma, under the table,
  undocumented)
• Research risk probability magnitude of
  reasonably foreseeable, identifiable harm
• Methods invasiveness data sensitivity
• Physiological (e.g., new diagnoses, side effects)
• Cognitive/emotional (e.g., stress, anxiety)
• Social (e.g., dismissal, deportation, reporting,
  subpoena)

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Proportionate Review Risk Matrix

• Review Type by Group Vulnerability Research
  Risk
• Research Risk
• Group vulnerability Low Med High
• Low Exp. Exp. Full
• Med Exp. Full Full
• High Full Full Full

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Forms, Deadlines, Guidelineswww.research.utoront
o.ca/ethics/

• Preparing a protocol
• Thesis proposal should be approved by thesis
  committee
• Follow model protocolse.g., from your research
  group
• Work closely with your supervisor
• Check reviewer guide consent doc guide
• Each section brief, clear, focused on ethics
• Submission
• Undergrad to local DERC coordinator
• Everyone else departmental sign off, then to ORE
• Expedited weekly, Mondays by 5pm Full REB
  monthly (except August), check website for
  deadlines

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Research Ethics IssuesFree Informed Consent

• Quality of researcher-participant relationship
  across all interactions, verbal or written
• emphasis on processnot just a signature on a
  page
• covers recruitment (verbal discussions, phone
  calls, letters, e-mail, ads), responses to
  questions, de-briefing
• Straight-forward explanation, warm invitational
  tone
• free not to participate, not to answer any
  question, to withdraw without consequence
• no undue influence (e.g., non-research roles) or
  inducement (e.g., financial)

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Research Ethics IssuesFree Informed Consent

• Plain language, not legalistic, typically gr.6-8
  level
• name, position, contact, any non-research roles
• study title, sponsor, purpose, procedures, time
  involvement, risks/benefits, how data will be
  used, limits to confidentiality
• sign off had study explained, questions
  answered, agree to begin, can withdraw
• Variations
• verbal if culturally more appropriate phone web
• personal versus alternate, assent (lt 14 years),
  dissent ethics approval, admin consent,
  community consultation

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Research Ethics IssuesFree Informed Consent

• Deception and debriefing
• Not inherently unethical good versus bad
  practices
• See TCPS, Article 2.1c) and commentary
• Is it necessary? Rigourously think through
  justification
• Low riski.e., vulnerable group? sensitive
  topic?
• Immediate, full debriefing? Clear, explicit
  explanation
• What elements were deceptiveremove any
  misconceptions
• Explain why necessary why importantnot
  arbitrary/capricious
• Re-consent option--i.e., can withdraw if not
  satisfied
• Report any concerns to REB

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Research Ethics IssuesPrivacy Confidentiality

• Identity and personal information
• Some projects name participants, attribute
  quotes
• Most projects protect personal information
• Consider throughout project
• Recruitment (e.g., confidentiality/anonymity,
  snowball referrals, phone messages)
• Data collection (e.g., focus groups/interviews,
  notes/recordings)
• Data storage plan separate identifiers from
  content double lock password protect,
  retention/destruction
• Publication pseudonyms, generics, aggregates

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Research Ethics IssuesPrivacy Confidentiality

• Possible limits to confidentiality
• Key informants (specialized group, readership)
• Duty to report
• child abuse
• intent to harm self or other
• Subpoena
• may be possible to challenge

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Research Ethics IssuesConflict of Interest

• Typically role-based
• e.g., researcher instructor/minister/manager
• real or perceived, must disclose non-research
  aspects
• may have to managee.g., not recruit directly,
  blind to participation until after relationship
  ends
• May have to abandon one interest

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Research Ethics IssuesInclusion/Exclusion
Criteria

• Principle of Justice
• fair distribution of benefits, burdens
• Need to justify basis for including/excluding
• students sometimes have trouble with complex
  constructs (e.g., sex/gender/sexual orientation,
  race/ethnicity/culture)

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More Informationwww.research.utoronto.ca/ethics/

• Information Assistant, Office of Research Ethics
• ethics.review_at_utoronto.ca, 6-3273
• Coordinator, Social Sciences, Humanities,
  Education
• bridgette.murphy_at_utoronto.ca, 6-5606
• Coordinator, Continuing Review (amendments,
  renewals, completions)
• marianna.richardson_at_utoronto.ca, 8-3165
• Research Ethics Analyst Consultation Service
  Undergrad Liaison
• dario.kuzmanovic_at_utoronto.ca, 6-3608
• Research Ethics Officer, Social Sciences,
  Humanities, Education
• dean.sharpe_at_utoronto.ca, 8-5585

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References

• Tri-Council Policy Statement (TCPS), tutorial,
  Social Sciences Humanities Working Committee
  (SSHWC) policy initiatives
• pre.ethics.gc.ca/english/policystatement/policysta
  tement.cfm
• pre.ethics.gc.ca/english/tutorial/
• pre.ethics.gc.ca/english/workgroups/sshwc.cfm
• UT/ORE website and Guidelines and practices
  manual
• www.research.utoronto.ca/ethics/
• www.research.utoronto.ca/ethics/pdf/human/nonspeci
  fic/ERO_Guidelines_Manual.pdf
• see UT guidelines on key informant interviews,
  participant observation, deception and
  debriefing, data security standards . . .