HUMAN RESEARCH ETHICS

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, CIHR٠ major national funding bodies

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

COMPLETE THE APPLICATION

• Follow HREB Guidelines• Complete all sections;

* if irrelevant, answer “N/A” • Use lay-language, not jargon• Handwritten applications not accepted

SUBMIT APPLICATION

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

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

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

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.

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

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.

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

POWER-OVER RELATIONSHIPTo 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).

MITIGATING POWER-OVER

third-party recruitment third party data collection exclude those over whom the researcher has a

direct power-over relationship complete anonymity

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

Recording Consent

signed verbal – recorded implied

Consent form template

RISKSParticipants have the right to be fully informed of any risksassociated 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.

ANONYMITYAnonymity 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.

CONFIDENTIALITYConfidentiality 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.

LIMITS TO CONFIDENTIALITYParticipants 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

CONTACT USOffice of Research Services (READ)University Centre, Room A240University of VictoriaPO Box 3025 STN CSCVictoria, BC V8W 3P2

Leah Potter Theresa HunterHuman Research Ethics Assistant Human Research Ethics Coordinatorovprhe@uvic.ca hrethics@uvic.ca472-4545 472-5202