Canadian governance of health research involving human subjects: is anybody minding the store?
From an ethical perspective, good governance involves the translation of collective moral intentions into effective and accountable institutional actions. With respect to the use of human subjects in Canadian health research, I contend that there have been many good intentions but very little in the way of appropriate governance arrangements. Hence, the question, "who minds the store?" is especially acute with respect to the protection of vulnerable individuals and groups that are typically recruited as subjects for health research in Canada. Beyond diagnosing failures in governance and their causes, I offer suggestions for significant reforms, including evidence-based ethics assessment, independent oversight, and greater participation of research subjects in governance. I will close with some more general reflections on ethics, law, and governance.
McDonald
M
M
Centre for Applied Ethics, University of British Columbia.
D002170:Canada; D003132:Commerce; D003659:Decision Making, Organizational; D004989:Ethics; D028744:Ethics Committees, Research / Q000458:organization & administration*; D004992:Ethics, Medical; D019317:Evidence-Based Medicine; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007391:International Cooperation; D028681:Moral Obligations; D011332:Privatization; D012106:Research / Q000458:organization & administration / Q000592:standards*