Canadian ethics review: worse than you think

Ted Schrecker, Research Associate,
October 07, 2003

Dear Editor

JME is to be congratulated for offering the important Olivieri Symposium free of charge on a pre-publication basis. The Olivieri and Healy affairs occurred at one university, in one province. Based on the articles by Arthur Schafer, Gordon DuVal, and Lorraine Ferris and colleagues, non-Canadian readers might underestimate the scope of the crisis confronting research ethics review in Canadian universities and hospitals. I would like to expand on two institutional aspects of that crisis, with primary reference to Ontario (Canada's largest province, the one with which I am most familiar, and the one to which the articles in the symposium refer). I have no reason to believe that the situation elsewhere is either better or worse.

If implemented, Gordon DuVal's proposal that REBs review many aspects of research contracts before they are approved by universities and hospitals would represent a major change for the better. However, his belief that REBs are "independent" bodies misses a crucial point. McDonald [1] has pointed out that 'university REBs generally report to the offices that promote research.' In many universities, the overwhelming majority of REB members are employees of the university or its affiliated hospitals; in one case, at least, they are appointed directly by the president of the university. Remarkably, no systematic published research on this point appears to exist, or to be in progress. Neither does the Tri-Council Statement of Principles, the federal granting councils' non- binding guidelines for REBs, include any requirements that address the independence of REB members. Under these circumstances, it is probably difficult for REBs to take positions, such as asking to scrutinize contractual arrangements for sponsored research, that will seriously impede their institutions' quest for research funding. An REB taking this position would also not be able to find any specific support for such an interpretation of its mandate in the Tri-Council Statement. Given the meagre resources normally available for REB activities, an REB wishing (for instance) to commission a legal opinion on this point would probably have to take up a collection among its members, or hold a bake sale.

Ethical concerns arising from the shift to private research funding in universities as a consequence of (policy-induced) scarcity of public funds are now generally acknowledged. Canadian hospitals confront a similar situation, and the tradeoffs they make in response are even less visible than those made by universities. In Ontario, hospitals can be (and have been) taken over by provincially appointed trustees for failure to balance their budgets,[2] but no comparable mechanism exists for scrutiny either of the ethical short-cuts that may have been taken in the interests of raising revenue, or of what happens to patient care once "business development" becomes a priority. Lorraine Ferris and her colleagues concede that hospital-based researchers may lack even the minimal protections against reprisal that are available in the university setting when ethics collide with institutional (read: financial) priorities. The CEO of Toronto's University Health Network, the hospital complex affiliated with the University of Toronto, recently stated in the context of a shortage of resources for pain care that: 'We decided that patient need, in a broad context, wasn't one of our criteria in deciding priorities.'[3] This is suggestive of a culture in which some patients have become more important than others, based inter alia on their value as clinical trial participants, suppliers of scientifically interesting biological materials, or sources of data that can then be "warehoused" for purposes of subsequent research.

Under these circumstances, it is hard not to be sceptical about proposals for improvements in the governance of research that fail to incorporate genuinely independent oversight, meaningful sanctions for misconduct, and a high level of transparency. On this last point, it should be noted that Ontario's hospitals and universities are both exempt from even the weak public disclosure requirements imposed on other public sector agencies by provincial freedom of information legislation.


(1) McDonald M. Canadian governance of health research involving human subjects: is anybody minding the store? Health Law Journal 2001;9:1-22.

(2) Heinz C. Government Taking Back Control of Public Hospitals. Hospital News 2002;15(12),December:12,14.

(3) Papp L. Patients' torment ignored. Toronto Star 2003; June 20.

Conflict of Interest

None declared