title: The Canadian agency for the oversight of research involving humans: a reform proposal.
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.
authors.affiliation: Health Law Institute, Dalhousie University, 6061 University Avenue, Halifax, Nova Scotia B3H 4H9, Canada. Jocelyn.Downie@Dal.Ca
authors.forename: Jocelyn
authors.initials: J
authors.lastname: Downie
mesh_terms: D002170:Canada; D026724:Ethical Review; D028744:Ethics Committees, Research; D035082:Federal Government; D006077:Government Agencies; D033161:Government Regulation; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans