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

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.

Keywords:

• Research ethics
• Governance of research
• Research ethics boards (REBs)
• Institutional research boards (IRBs)

Acknowledgments

The author would like to acknowledge the support of the Canada Research Chairs Program and the Nova Scotia Health Research Foundation. She would also like to thank the following for helpful comments on prior drafts of this article: Brad Abernethy, Michael Hadskis, the members of the Dalhousie University Health Law Institute, and the members of the Novel Genetic Technologies Research Team.

Notes

¹Thus, immediately, significant differences with the Panel on Research Ethics (PRE) are evident. The work of the Policy Committee will apply to all research, not just research conducted in Agency-funded institutions and the Policy Committee will be independent of the funding Agencies (PRE is not fully independent, cf. Downie, 2005). The proposed system would see PRE dissolved.

²Much of this work is currently being done by NCEHR. The proposed system would see NCEHR—as it is currently constituted and funded—cease to exist. However, I would hope it would also see the individuals involved with NCEHR actively engaged in the work of the Education Branch and the prior work of NCEHR embraced as the foundation upon which the Education Branch would be built.

Canada Corporations Act, R.S. 1970, c. C-32.

Durham, G. (2005). E-mail communication from Gillian Durham, Deputy Director-General, Sector Policy Directorate. New Zealand: April 12, 2005

Food and Drug Regulations (1985), C.R.C., c.870, ss.G05.003(5), G.05.002

Hadskis, M., and Carver, P. (2005). The long arm of administrative law: Applying administrative law principles to research ethics boards. Health Law Review 13: 19–33

Health Information Act, R.S.A. 2000, c. H-5, s.27

Health Information Protection Act, S.S. 1999, c. H-0.021, s.29

Jones, D. (2002). Issue Identification Paper: Governance of Research Involving Human Subjects. Report submitted to Health Canada.

National Council on Ethics in Human Research (NCEHR). (2005). Options for the Development of an Accreditation System for Human Research Protection Programs: Request for Comments. Circulated by e-mail, on file with author.

Personal Health Information Act S.M. 1997, c. P33.5, s.24.

Personal Health Information Protection Act, 2004, S.O. 2004, c.3 Sched. A, s.37.

Thompson, J. (2004). Statistics Canada Estimates of Canadian research and development expenditures (GERD), Canada, 1993 to 2004, and by province 1993 to 2002. Catalogue no. 88F0006XIE – No. 020. Ottawa: Science, Innovation, and Electronic Information Division.