The Canadian Agency for the Oversight of Research Involving Humans: A Reform Proposal

Document Type

Article

Publication Date

2006

Keywords

Research Ethics, Governance Of Research, Research Ethics Boards (REBs), Institutional Research Boards (IRBs), Recommendations for Reform, Research Involving Humans

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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