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DERC_background.ppt DERC_background.ppt Presentation Transcript

  • 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
  • Outline
    • Participant protection & research ethics review framework
    • Risk
    • Issues primer
    • Next talk: DERC Administration
  • Participant Protection History & 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
  • 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 (>minimal risk)
    • Continuing review (annual renewal, site visits)
  • 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
  • DERCs & Undergrad Research
    • Not one size fits all—should 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/supervision
    • Expect mostly minimal risk/expeditable protocols, or unusual circumstances (e.g., extensive experience)
  • 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 PDAD&C 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
  • Assessing Risk: Probability & 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)
  • Risk Matrix Probability & 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
  • Review Issues: Free & 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 (<14 years), dissent
  • Review Issues: Privacy & 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
  • Review Issues: Conflict of Interest
    • Typically role-based
    • e.g., researcher + teacher/minister/manager
    • real or perceived, must disclose non-research aspects
    • may have to manage—e.g., not recruit directly, blind to participation
    • May have to abandon one interest
  • Review Issues: Inclusion/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)
  • Next Talk: DERC 101: Administration