Research Involving Human Participants

1. Research Involving Human Participants Challenges and Opportunities in Field Research: Lessons from Faculty and Graduate Research in Cross-Cultural Contexts November 13, 2006

2. Need for Ethics Review • Respect for human dignity • Respect for Free and Informed Consent • Respect for Vulnerable Persons • Respect for Privacy and Confidentiality • Respect for Justice and Inclusiveness • Balancing Harms and Benefits • Minimizing Harm

3. When is it necessary to submit a review for ethics approval? If you are collecting information from people (participants) using • Surveys, questionnaires, interviews, focus groups • Participant or naturalistic observation • Experimental methods • Use secondary data with identifying information • Ethics approval must be obtained prior to starting the research

4. “Minimal Risk” Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans1 (TCPS) establishes procedures and standards for ethics review Minimal Risk (as defined by TCPS) the probability and magnitude of possible harm implied by participation in the research is not greater than that encountered by the subject in those aspects of his or her everyday life 1TCPS: www.pre.ethics.gc.ca

5. University Research Ethics Board (REB) The REB is mandated to approve, reject, review or terminate research involving human participants conducted within, or by members of, the WLU community based on the TCPS. The composition of the REB includes • Chair, Dr. Bill Marr • at least seven faculty members from different departments/faculties • a community representative • a staff member from Psychology who is responsible for coordinating their reviews • ex-officio, non-voting members from the Office of Research Services

6. University Research Ethics Board • Faculty and staff research • Graduate student research • Undergraduate student research if the project will become part of a faculty member’s own research program or if the participants are at a greater than “minimal risk” by participating

7. Exceptions to REB Review • Undergraduate student research with “minimal risk” to participants (reviewed by Departmental Ethics Review Committee) • Research about a living individual in a public arena, or an artist, based exclusively on publicly available data • Quality assurance studies, performance review, or testing within normal educational requirements (reviewed by Administrative Ethics Review Board) • Research undertaken by students on co-op work terms outside the auspices of WLU that does not require WLU resources and is not directly supervised by WLU faculty or staff

8. Full Review vs. Expedited Review Full Review • Requires face-to-face review before the REB if research involves greater than “minimal risk”, or if Chair requests full Board review Expedited Review • Proposal will be reviewed by Chair of the REB as well as at least one other additional REB member

9. The Review Process at WLU • Before starting your submission to the REB, review the WLU Research Ethics Policy (http://www.wlu.ca/page.php?grp_id=1430&p=5470) • TCPS policy statement and tutorial (http://www.pre.ethics.gc.ca/english)

10. The Review Process at WLU • Submit the Request for Ethics Review form and associated documents to the Office of Research Services • Associated documents could include • Information letter/informed consent statement • Surveys/questionnaires • Telephone script • Recruitment posters

11. The Review Process at WLU • For student research, a Confirmation of Supervisor’s or Instructor’s Review form must also be submitted which confirms your faculty advisor/course instructor has read your ethics application • All forms can be found on Research Office website, Research Involving Humans (http://www.wlu.ca/homepage.php?grp_id=1430)

12. The Review Process at WLU • Application is forwarded to the Chair and at least one other REB memberfor review • Comments from the reviewers are sent to the Research Grants Officer (RGO) and a memo combining reviewers’ comments is prepared • The memo is sent to the researcher by internal mail and email

13. The Review Process at WLU • Researcher submits any clarifications or corrections to the RGO • Chair reviews the changes • If all comments addressed, approval letter sent to researcher • Your initial response from the REB should be received within two weeks of submission

14. Changes to Research Program • Should the research program change, a Request for Ethics Clearance of a Revision or Modification form must be completed and submitted to the REB for approval

15. Other Reports • Annual reviews for on-going projects must be submitted to the Research Office • Students must submit “Final Report on Human Research Projects” prior to graduation

16. Other Reports • Should a participant be adversely affected (emotional, psychological or physiological in nature) as a result of their involvement in the research, the REB Chair must be notified immediately and an Adverse EventsReport must be submitted

17. Research Involving Aboriginal Peoples • Guidelines do not replace ethical standards for research involving human participants but rather ensure that the rights and interests of the community as a whole are respected

18. Research Involving Aboriginal Peoples • Research involving Aboriginal groups gives rise to both special considerations and to basic ethical duties regarding ethics review, informed consent, confidentiality, conflict of interest and inclusion • Aboriginal Peoples have a unique interest in ensuring accurate and informed research concerning their heritage, customs and community

19. Research Involving Aboriginal Peoples • Why special guidelines for research involving Aboriginal Peoples? • they have been treated as a source of data • cultural property has been expropriated by researchers • inaccurate or insensitive research has caused stigmatization • Respect for human dignity must be maintained.

20. Research Involving Aboriginal Peoples • Researcher must be aware of the different culture (customs, rituals, etc.) • Language differences may impede clear communication when obtaining informed consent

21. Research Involving Aboriginal Peoples - Special Considerations • Will be property/private information belonging to the group as whole be studied or used? • Will the leaders of the group be involved in identifying potential participants? • Will the research analyze or describe characteristics of the group? • Will individuals be selected to speak on behalf of, or otherwise represent, the group?

22. Research Involving Aboriginal Peoples – Good Practices • Respect the culture, traditions and knowledge of the Aboriginal People • Conduct research with the group as a partnership • Consult members of the group who have relevant expertise • Involve the group in the design of the project

23. Research Involving Aboriginal Peoples – Good Practices • Allow the community an opportunity to review, respond and react to the research findings before completing final report

24. Research Involving Aboriginal Peoples – Good Practices • Refer to Section 6 of the TCPS (http://www.pre.ethics.gc.ca/english/policystatement/section6.cfm) for a complete list of Good Practices and more details regarding Research Involving Aboriginal Peoples

25. WLU Contacts Rosemary Springett Research Grants Officer Extension 3131 Sally Gray Manager of Research Services Extension 3528 Bill Marr Chair, University Research Ethics Board Extension 2468