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HUMAN RESEARCH ETHICS. TRI-COUNCIL POLICY The University has adopted the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans.

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Presentation on theme: "HUMAN RESEARCH ETHICS. TRI-COUNCIL POLICY The University has adopted the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans."— Presentation transcript:

1 HUMAN RESEARCH ETHICS

2 TRI-COUNCIL POLICY The University has adopted the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans (TCPS) as the minimum standard Tri-Council: SSHRC, NSERC, CIHR ٠ major national funding bodies

3 UVIC ETHICS Human Research Ethics Board (HREB) Guidelines and Application on Office of Research Services (ORS) Website: http://www.research.uvic.ca/forms/index.htm

4 COMPLETE THE APPLICATION Follow HREB Guidelines Complete all sections; * if irrelevant, answer “N/A” Use lay-language, not jargon Handwritten applications not accepted

5 SUBMIT APPLICATION Call us if you have questions Supervisory committee to review Signatures required 1 original signed and 3 copies

6 ATTACHMENTS Attach all pertinent documents, such as:  Recruitment materials, e.g., script(s), letter(s)  Consent form(s)  Research instruments  Approval from external organizations  Request to Use Deception form  Human Tissues form

7 APPLICATION REVIEW PROCESS Typically 4 – 6 week process First assess risk (see TCPS) Then assign review process Minimal risk:  Expedited – Staff and Chair  Review – 2 HREB members, staff and Chair Not minimal risk: HREB

8 TCPS DEFINITION OF “MINIMAL RISK The research can be regarded as minimal risk if potential participants can reasonably expect to regard the possible harms implied by participation in the research to be no greater than those encountered by the participant in those aspects of his or her everyday life that relate to the research.

9 NOTICE OF REVIEW Notice of review sent Revisions often required Revisions received 2 nd Notice of review? Approval Certificate of Approval

10 RECRUITMENT Participants have the right to know why they are being asked to participate and how you obtained their names. If third parties or organizations assist with recruitment, it must be done in ways that conform to privacy regulations.

11 “Free and informed consent lies at the heart of ethical research involving human subjects” (TCPS p. 2.1)

12 POWER-OVER RELATIONSHIP To be ethical, participation must be voluntary. If potential participants are in a power-over relationship with the researcher, they may not feel entirely free to participate or not. Potential participants may also perceive positive inducements for their participation (e.g., gaining advantages or earning favour).

13 MITIGATING POWER-OVER  third-party recruitment  third party data collection  exclude those over whom the researcher has a direct power-over relationship  complete anonymity

14 CONSENT  Consent is a process, not just a form  Full disclosure (unless need to use deception)  Time to consider and ask questions  Voluntary and able to withdraw at any time  On-going consent

15 Recording Consent  signed  verbal – recorded  implied

16 Consent form template

17 RISKS Participants have the right to be fully informed of any risks associated with their involvement in the study, including:  Psychological/emotional: e.g., increased sadness, anxiety, fear, depression, loss of privacy and re-traumatization  Social: e.g., loss of status, respect, alienation, social stigma  Physical: e.g., pain, scarring, infection  Economic: e.g., threats of job Measures to prevent/minimize risks and respond to harms.

18 ANONYMITY Anonymity means that there is no way the researcher can ever link the data to the participant. Anonymity can range from full to none. It depends on the study.

19 CONFIDENTIALITY Confidentiality refers to the protection of the participants’ identity (anonymity) and the protection, access, control and security of his or her data and personal information during recruitment, data collection, dissemination of data and findings and storage.

20 LIMITS TO CONFIDENTIALITY Participants must be made aware of limits to anonymity and confidentiality in the consent process. Confidentiality may be breached when: the law requires it (eg disclosure of child abuse) or there is a reasonable expectation of harm occurring to the participant or others

21 CONTACT US Office of Research Services (READ) University Centre, Room A240 University of Victoria PO Box 3025 STN CSC Victoria, BC V8W 3P2 Leah PotterTheresa Hunter Human Research Ethics AssistantHuman Research Ethics Coordinator ovprhe@uvic.caovprhe@uvic.cahrethics@uvic.ca 472-4545 472-5202


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