HUMAN RESEARCH ETHICS

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HUMAN RESEARCH ETHICS

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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
• ? major national funding bodies

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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

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COMPLETE THE APPLICATION

• Follow HREB Guidelines
• Complete all sections if irrelevant, answer
  N/A
• Use lay-language, not jargon
• Handwritten applications not accepted

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SUBMIT APPLICATION

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

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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

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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

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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.

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NOTICE OF REVIEW

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

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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.

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

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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).

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MITIGATING POWER-OVER

• third-party recruitment
• third party data collection
• exclude those over whom the researcher has a
  direct power-over relationship
• complete anonymity

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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

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Recording Consent

• signed
• verbal recorded
• implied

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• Consent form template

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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.

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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.

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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.

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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

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CONTACT US

• Office of Research Services (READ)University
  Centre, Room A240University of VictoriaPO Box
  3025 STN CSCVictoria, BC V8W 3P2
• Leah Potter Theresa Hunter
• Human Research Ethics Assistant Human Research
  Ethics Coordinator
• ovprhe_at_uvic.ca hrethics_at_uvic.ca
• 472-4545 472-5202