DERC 101: Delegated Ethics Review of Undergrad Research

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DERC 101 Delegated Ethics Review of Undergrad
Research

• Dean Sharpe Jill Parsons
• Ethics Review Office, University of Toronto
• Delegated Ethics Review Committee Retreat
• June 16, 2006

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Outline

• Participant protection research ethics review
  framework
• Risk
• Issues primer
• Next talk DERC Administration

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Participant ProtectionHistory Principles

• Landmark documents
• Nuremberg code (1947)
• Declaration of Helsinki (1964)
• Belmont report/common rule (1979)
• Tri-council policy statement (TCPS, 1998) MOUs
• Key ideas
• Respect for human dignity, autonomy
• Balance distribution of harms/benefits

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Research Ethics Review

• Issues
• Free informed consent
• Privacy confidentiality
• Conflict of Interest
• Inclusion/exclusion criteria
• Proportionate review procedures
• Exempt (educational testing, program evaluation)
• Delegated undergrad DERC review
• Delegated expedited review (minimal risk)
• Research Ethics Board REB review (gtminimal
  risk)
• Continuing review (annual renewal, site visits)

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Ethics Review Office (ERO)Mandate Participant
Protection

• Facilitate research ethics review
• Establish, coordinate oversee REBs DERCs
• Maintain institutional compliance
• Develop implement guidelines procedures with
  the Committee on Human Subjects in Research
  (CHSR)
• Educate research community
• Conduct workshops, seminars, retreats outreach
  for researchers, students, staff, participants

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DERCs Undergrad Research

• Not one size fits allshould be tailored to
• Nature, scale risk of activities in relevant
  disciplines
• Review process should be efficient effective
• 2 types of undergrad protocols
• Course templates student-initiated projects
• Also look at research-like/experiential learning
  activities
• Evaluate/minimize risk relative to
• Pedagogical goals relevant experience/supervisio
  n
• Expect mostly minimal risk/expeditable protocols,
  or unusual circumstances (e.g., extensive
  experience)

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DERC ERO Roles

• DERCs (next talk will address in more detail)
• Conduct reviews consult with/escalate to ERO
• Keep protocol files meeting minutes
• Report annually to ERO
• ERO (see web site for more details)
• CHSR guidelines and PDADC memo (Spring, 2005)
• Draft DERC terms of reference, course template
  student-initiated project protocol forms,
  reporting spreadsheet
• Sample course templates available on request
• Ongoing consultation/review of escalated protocols

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Assessing RiskProbability Magnitude of Harm

• Vulnerability of group
• Physiological (e.g., health)
• Cognitive/emotional (e.g., impairment, trauma)
• Social (e.g., stigma, economic/legal status)
• Research risk
• Methods invasiveness data sensitivity
• Physiological (e.g., diagnoses, side effects)
• Cognitive/emotional (e.g., stress, anxiety)
• Social (e.g., identifiable harm as a result of
  breach dismissal, deportation duty to report,
  subpoena)

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Risk MatrixProbability Magnitude of Harm

• 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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Review IssuesFree Informed Consent

• Free not to participate, not to answer any
  question, to withdraw, without consequence no
  undue inducement
• Informed plain language--name, position,
  affiliation, contact info study title, purpose,
  sponsor procedures, time involvement,
  risks/benefits non-research aspects retention
  uses of data, limits to confidentiality
• Sign study explained, questions answered, agree
  to begin
• Variations verbal (if written culturally
  inappropriate) ethics approval, administrative
  consent, personal vs alternate, assent (lt14
  years), dissent

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Review IssuesPrivacy Confidentiality

• Duty to protect personal information
• to the extent permitted by law duty to report
  child abuse, intent to harm self or other
  subpoena
• Plan retention/destruction of raw data
• Separate identifiers from content double lock
  password protect
• Manage limits to confidentiality
• Focus groups, key informants
• Pseudonyms, generics, aggregates

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Review IssuesConflict of Interest

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

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Review 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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Next TalkDERC 101 Administration