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DERC 101: Delegated Ethics Review of Undergrad Research Dean Sharpe & Jill Parsons Ethics Review Office, University of Tor...
Outline <ul><li>Participant protection & research ethics review framework </li></ul><ul><li>Risk </li></ul><ul><li>Issues ...
Participant Protection History & Principles <ul><li>Landmark documents </li></ul><ul><li>Nuremberg code (1947) </li></ul><...
Research Ethics Review <ul><li>Issues </li></ul><ul><li>Free & informed consent </li></ul><ul><li>Privacy & confidentialit...
Ethics Review Office (ERO) Mandate: Participant Protection <ul><li>Facilitate research ethics review </li></ul><ul><li>Est...
DERCs & Undergrad Research <ul><li>Not one size fits all—should be tailored to: </li></ul><ul><li>Nature, scale & risk of ...
DERC & ERO Roles <ul><li>DERCs (next talk will address in more detail) </li></ul><ul><li>Conduct reviews & consult with/es...
Assessing Risk: Probability & Magnitude of Harm <ul><li>Vulnerability of group </li></ul><ul><li>Physiological (e.g., heal...
Risk Matrix Probability & Magnitude of Harm <ul><li>Review Type by Group Vulnerability & Research Risk </li></ul><ul><li>R...
Review Issues: Free & Informed Consent <ul><li>Free:  not to participate, not to answer any question, to withdraw, without...
Review Issues: Privacy & Confidentiality <ul><li>Duty to protect personal information </li></ul><ul><li>“ to the extent pe...
Review Issues: Conflict   of Interest <ul><li>Typically role-based </li></ul><ul><li>e.g., researcher + teacher/minister/m...
Review Issues: Inclusion/Exclusion Criteria <ul><li>Principle of Justice </li></ul><ul><li>fair distribution of benefits, ...
Next Talk: DERC 101: Administration
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Transcript of "DERC_background.ppt"

  1. 1. 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
  2. 2. Outline <ul><li>Participant protection & research ethics review framework </li></ul><ul><li>Risk </li></ul><ul><li>Issues primer </li></ul><ul><li>Next talk: DERC Administration </li></ul>
  3. 3. Participant Protection History & Principles <ul><li>Landmark documents </li></ul><ul><li>Nuremberg code (1947) </li></ul><ul><li>Declaration of Helsinki (1964) </li></ul><ul><li>Belmont report/common rule (1979) </li></ul><ul><li>Tri-council policy statement (TCPS, 1998) & MOUs </li></ul><ul><li>Key ideas </li></ul><ul><li>Respect for human dignity, autonomy </li></ul><ul><li>Balance & distribution of harms/benefits </li></ul>
  4. 4. Research Ethics Review <ul><li>Issues </li></ul><ul><li>Free & informed consent </li></ul><ul><li>Privacy & confidentiality </li></ul><ul><li>Conflict of Interest </li></ul><ul><li>Inclusion/exclusion criteria </li></ul><ul><li>Proportionate review procedures </li></ul><ul><li>Exempt (educational testing, program evaluation) </li></ul><ul><li>Delegated undergrad “DERC” review </li></ul><ul><li>Delegated “expedited” review (“minimal risk”) </li></ul><ul><li>Research Ethics Board “REB” review (>minimal risk) </li></ul><ul><li>Continuing review (annual renewal, site visits) </li></ul>
  5. 5. Ethics Review Office (ERO) Mandate: Participant Protection <ul><li>Facilitate research ethics review </li></ul><ul><li>Establish, coordinate & oversee REBs & DERCs </li></ul><ul><li>Maintain institutional compliance </li></ul><ul><li>Develop & implement guidelines & procedures with the Committee on Human Subjects in Research (CHSR) </li></ul><ul><li>Educate research community </li></ul><ul><li>Conduct workshops, seminars, retreats & outreach for researchers, students, staff, participants </li></ul>
  6. 6. DERCs & Undergrad Research <ul><li>Not one size fits all—should be tailored to: </li></ul><ul><li>Nature, scale & risk of activities in relevant disciplines </li></ul><ul><li>Review process should be efficient & effective </li></ul><ul><li>2 types of undergrad protocols </li></ul><ul><li>Course templates & student-initiated projects </li></ul><ul><li>Also look at research-like/experiential learning activities </li></ul><ul><li>Evaluate/minimize risk relative to: </li></ul><ul><li>Pedagogical goals & relevant experience/supervision </li></ul><ul><li>Expect mostly minimal risk/expeditable protocols, or unusual circumstances (e.g., extensive experience) </li></ul>
  7. 7. DERC & ERO Roles <ul><li>DERCs (next talk will address in more detail) </li></ul><ul><li>Conduct reviews & consult with/escalate to ERO </li></ul><ul><li>Keep protocol files & meeting minutes </li></ul><ul><li>Report annually to ERO </li></ul><ul><li>ERO (see web site for more details) </li></ul><ul><li>CHSR guidelines and PDAD&C memo (Spring, 2005) </li></ul><ul><li>Draft DERC terms of reference, course template & student-initiated project protocol forms, reporting spreadsheet </li></ul><ul><li>Sample course templates available on request </li></ul><ul><li>Ongoing consultation/review of escalated protocols </li></ul>
  8. 8. Assessing Risk: Probability & Magnitude of Harm <ul><li>Vulnerability of group </li></ul><ul><li>Physiological (e.g., health) </li></ul><ul><li>Cognitive/emotional (e.g., impairment, trauma) </li></ul><ul><li>Social (e.g., stigma, economic/legal status) </li></ul><ul><li>Research risk </li></ul><ul><li>Methods invasiveness & data sensitivity </li></ul><ul><li>Physiological (e.g., diagnoses, side effects) </li></ul><ul><li>Cognitive/emotional (e.g., stress, anxiety) </li></ul><ul><li>Social (e.g., identifiable harm as a result of breach: dismissal, deportation; duty to report, subpoena) </li></ul>
  9. 9. Risk Matrix Probability & Magnitude of Harm <ul><li>Review Type by Group Vulnerability & Research Risk </li></ul><ul><li>Research Risk </li></ul><ul><li>Group vulnerability Low Med High </li></ul><ul><li>Low Exp. Exp. Full </li></ul><ul><li>Med Exp. Full Full </li></ul><ul><li>High Full Full Full </li></ul>
  10. 10. Review Issues: Free & Informed Consent <ul><li>Free: not to participate, not to answer any question, to withdraw, without consequence; no undue inducement </li></ul><ul><li>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 </li></ul><ul><li>Sign: study explained, questions answered, agree to begin </li></ul><ul><li>Variations: verbal (if written culturally inappropriate); ethics approval, administrative consent, personal vs alternate, assent (<14 years), dissent </li></ul>
  11. 11. Review Issues: Privacy & Confidentiality <ul><li>Duty to protect personal information </li></ul><ul><li>“ to the extent permitted by law”: duty to report child abuse, intent to harm self or other; subpoena </li></ul><ul><li>Plan retention/destruction of raw data </li></ul><ul><li>Separate identifiers from content; double lock; password protect </li></ul><ul><li>Manage limits to confidentiality </li></ul><ul><li>Focus groups, key informants </li></ul><ul><li>Pseudonyms, generics, aggregates </li></ul>
  12. 12. Review Issues: Conflict of Interest <ul><li>Typically role-based </li></ul><ul><li>e.g., researcher + teacher/minister/manager </li></ul><ul><li>real or perceived, must disclose non-research aspects </li></ul><ul><li>may have to manage—e.g., not recruit directly, blind to participation </li></ul><ul><li>May have to abandon one interest </li></ul>
  13. 13. Review Issues: Inclusion/Exclusion Criteria <ul><li>Principle of Justice </li></ul><ul><li>fair distribution of benefits, burdens </li></ul><ul><li>Need to justify basis for including/excluding </li></ul><ul><li>students sometimes have trouble with complex constructs (e.g., sex/gender/sexual orientation, race/ethnicity/culture) </li></ul>
  14. 14. Next Talk: DERC 101: Administration
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