Research Involving Human

Participants

Challenges and Opportunities in Field Research: Lessons from Faculty and Graduate Research in Cross-Cultural

Contexts

November 13, 2006

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

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;• Secondary data with identifying information;

then ethics approval must be obtained prior to starting the research.

“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

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

Proposals reviewed by the 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

Special Circumstances

Undergraduate student research with “minimal risk” to participants is reviewed by the Departmental Ethics Review Committee.

Research about a living individual in a public arena, or an artist, based exclusively on publicly available data does not need REB approval.

Quality assurance studies, performance review, or testing within normal educational requirements are reviewed by the 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 does not need WLU REB approval (check guidelines at place of employment). Subsequent use of any data acquired may need REB approval.

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

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)

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

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).

The Review Process at WLU

Application is forwarded to the Chair and at least one other REB member for review.

Comments from the reviewers are sent to the Research Grants Officer (RGO) and a memo reflecting reviewers’ comments is prepared.

The memo is sent to the researcher by internal mail and e-mail.

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. Initial response from the REB should be received within

two weeks of submission – please contact RGO if you do not hear from the REB within two weeks.

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.

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.

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 Events Report must be submitted. Note that lost or stolen data represents an adverse event because of possible loss of confidentiality and/or anonymity of participants.

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.

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.

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.

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.

Community consent as well as individual consent may be needed.

Consent may build gradually over the course of the research project.

Research Involving Aboriginal Peoples - Special Considerations

Will 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?

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

Research Involving Aboriginal Peoples – Good Practices

Allow the community an opportunity to review, respond and react to the research findings before completing final report

If available, provide the REB with documentation regarding best practices or cultural norms for the community you are studying.

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

CIHR Guidelines for Health Research Involving Aboriginal Peoples - Draft for consultation (http://www.cihr.ca/e/29134.html)

Research Involving Aboriginal Peoples – Case History

For an account of the Nuu-chah-nulth blood study, see:http://www.caj.ca/mediamag/awards2005/Pages/Community%20Newspaper.htm.

Guidelines and Flexibility

The TCPS and REBs in general have come under fire at many universities because of perceived inflexibility and adherence to rules that were based on medical research practices. Laurier’s REB is willing to work with researchers to ensure that the guiding principles of the TCPS are adhered to within the context of the research proposal.

Guidelines and Flexibility (cont.)

Do not hesitate to contact the RGO if you have any questions about the REB’s suggestions, or if you feel those suggestions are not a viable option for your research.

WLU Contacts

Rosemary SpringettResearch Grants OfficerExtension 3131

Sally GrayManager of Research ServicesExtension 3528

Bill MarrChair, University Research Ethics BoardExtension 2468