Some Things to Consider When Submitting a Protocol

1. Some Things to Consider When Submitting a Protocol Dario Kuzmanović Office of Research Ethics U of T May 2009

2. Types of Review REBs • Delegated (formerly Expedited) Review • Full Board Review May 2009

3. Delegated Review • Reviewed by a delegate of the REB • Protocol is considered to be low risk or has been reviewed by another REB Fig. 2 RISK MATRIX: Review Type by Group Vulnerability and Research Risk May 2009

4. Conflict of Interest (10) • Researcher (s), members of the research team, and/or their partners receive any personal benefits as a result of being connected to this study • Researcher may have undue influence over either the potential participants or the results of the study May 2009

5. Rationale (11) • Invalid/unreliable research may not be ethical • May mislead or put participants at risk • Better methodology increases possible benefits • Particularly important as risk increases • If the research question is not relevant to the community, the results will likely have no impact • Consider in advance the potential outcomes of the study • - Are the results likely to be interpreted in such a way as to be harmful to the community? May 2009

6. Methodology (12) • What will happen from the perspective of the participant or community • Are any personal questions/procedures unnecessary? • Consider the context – social, legal, economic, cultural, or other – that shapes the participants' life and the community dynamics • Does the plan for dissemination include accessible feedback to the community? May 2009

7. Participants or data subjects (13) • What information is requested? • Are the inclusion/exclusion criteria appropriate? • Is there a justification for the exclusion of certain populations? • Have all the relevant voices in the community been solicited? • For CBR, is there a partnership agreement in place? May 2009

8. Recruitment (15) • Appropriate to the context in which the research is conducted? • Are the recruitment materials misleading or lacking in detail? • Is there the potential for undue influence? • Deciding in front of peers or community leaders • Being asked by someone with authority or influence over participants – teacher, service provider, employer • Large payments to research participants or recruiters? May 2009

9. Selection and Recruitment (15) • Special concerns: • Captive populations – students, colleagues, employees, service recipients, prisoners • Vulnerable populations – lack of ability to give informed consent due to circumstances or diminished capacity • Peer Research Assistants – are they likely to make people more or less comfortable, are they adequately supported, are they considered participants? May 2009

10. Compensation (16) • Will the participants/community be compensated for participation? • Financial or in-kind? Other? • Is it large enough to be respectful? • Is it so high as to create undue pressure? • REB Test: is the amount so great as to motivate someone to accept a higher level of risk than they would otherwise? • How will compensation be used/distributed? May 2009

11. Risks (17) • Physical Risk (including any bodily contact or administration of any substance) • Psychological Risk (including feeling demeaned, embarrassed, worried or upset) • Loss of self-confidence or self-respect • Embarrassment from personal questions • Regret or guilt over what is revealed May 2009

12. Risks (17) • Social Risk (including possible loss of status, privacy and/or reputation) • Loss of respect by others • Loss of time & wages • Loss of status or reputation should confidentiality be breached • Further stigmatizing or marginalizing communities • Legal Risk • Duty to report • Potential subpoena of research results • Identification with illegal activity due to participation in study May 2009

13. Benefits (18) • Are the anticipated benefits fairly represented? • Do the anticipated benefits outweigh the foreseeable risks? • Are the benefits likely to affect all members of a community equitably? • Is capacity building and training for community members part of the research plan? May 2009

14. Informed Consent (19) • Is a process, not a form • Generally, participants must have the capacity to understand the study • Emphasize voluntary choice, include options for assent or dissent when proxy consent is sought • Generally, full disclosure of research purpose, what will happen, risks, benefits • Should avoid reinforcing established hierarchies in the community May 2009

15. The Consent Process (19) • How will consent be documented • Often by signature on written consent form, BUT sometimes better to avoid signature to guarantee protection or to respect cultural norms • Oral or other forms of consent still needs to be documented • REB recommends that the person facilitating the consent process ask participants what they understand about the study (i.e., what it is they are expected to do) prior to soliciting their consent May 2009

16. Confidentiality (23) • Breaches by other participants (focus groups) • Researcher’s obligation to report suspected child abuse or neglect, threat of harm to self or others (other factors based on professional role) • Court orders (research on illegal activity) • Identifying information present in aggregate data (e.g. residual disclosure) • The appropriateness of the data ownership agreement May 2009

17. Resources • http://www.research.utoronto.ca/ethics/ • Office location – 12 Queen’s Park Crescent W • See UofT guidelines on key informant interviews, participant observation, deception and debriefing, etc • Consultation service – Dario Kuzmanović, 416.946.3608 • TCPS – online tutorial & document May 2009

18. Meeting Dates Due Dates • June 1, 2009 May 19 • July 6, 2009 June 22 • August 5, 2009 July 22 • September 9, 2009 August 26 • October 8, 2009 Sept 24 May 2009

19. Questions: • Rupert Kaul – Co-Chair HIV REB • Darien Taylor – Co-Chair HIV REB • Dario Kuzmanović – Research Ethics Analyst dario.kuzmanovic@utoronto.ca May 2009