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A Canadian System of Oversight for the Governance of Research Involving Human Subjects

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To protect the rights and well-being of research subjects ... Law Commission of Canada's ... USA equalization / expatriation of Common Rule. Duty of care. ... – PowerPoint PPT presentation

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Title: A Canadian System of Oversight for the Governance of Research Involving Human Subjects


1
A Canadian System of Oversight for the Governance
of Research Involving Human Subjects
  • Health Canada, Ethics Division
  • Tim_Flaherty_at_hc-sc.gc.ca
  • March 10, 2002

2
Issue
  • The development of a system of oversight for the
    governance of research involving human subjects.
  • Objectives
  • To protect the rights and well-being of research
    subjects
  • To promote scientifically sound research.
  • To maintain and enhance the public trust in
    research involving human subjects..

3
Pressures
  • Law Commission of Canadas report by Michael
    McDonald.
  • Increasing evidence of misconduct in research.
  • New anti-conflict of interest guidelines set by
    major medical journals.
  • USA equalization / expatriation of Common Rule.
  • Duty of care.

4
Elements of Federal / National Oversight Regime
  • A comprehensive oversight system would include
  • Developed Policy and Standards
  • Research Ethics Education and Training.
  • Accreditation of Research Ethics Boards (REBs).
  • Certification of REB members.
  • Effective monitoring of research
  • National Level Review of specific research.
  • Research into research involving human subjects.

5
Scope of Oversight
  • All research involving human subjects conducted,
    partnered, or sponsored by the federal
    government
  • and
  • All research involving human subjects which is
    used in the development of products or services
    regulated by the federal government.

6
Implementing the Proposal
  • Roll-out over four years
  • Year 1 Consultation and Integration project
  • Years 2-3 Gradual implementation by federal
    departments. Nation-wide implementation with
    permanent national authority.

7
Next Steps
  • Broader, more public consultations with
    stakeholders on
  • - governance policy
  • - accreditation of Research Ethics Boards
  • - roles and responsibilities in governance.
  • Establishing task group to oversee consultations
    and implementation sites.
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