The Canadian Agency for the Oversight of Research Involving Humans: A Reform Proposal |
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Authors: | JOCELYN DOWNIE |
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Institution: | 1. Health Law Institute, Dalhousie University , Halifax, Nova Scotia, Canada Jocelyn.Downie@Dal.Ca |
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Abstract: | In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada’s current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of “frequently asked questions” about the proposed agency design such as “What about ‘local context’?” and “Why not have a system of accreditation of institutional REBs instead?” In sum, radical reform is needed and, in this paper, I present a proposal for such reform. |
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Keywords: | Research ethics Governance of research Research ethics boards (REBs) Institutional research boards (IRBs) |
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