The Canadian agency for the oversight of research involving humans: a reform proposal

Account Res. 2006 Jan-Mar;13(1):75-100. doi: 10.1080/08989620600588969.

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.

MeSH terms

  • Canada
  • Ethical Review
  • Ethics Committees, Research*
  • Federal Government
  • Government Agencies
  • Government Regulation*
  • Human Experimentation / legislation & jurisprudence*
  • Humans