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Response from Lemmens and Elliot
Posted by plosmedicine on 31 Mar 2009 at 00:00 GMT
Author: Trudo Lemmens
Position: Associate Professor, Faculty of Law
Institution: University of Toronto
Additional Authors: Carl Elliot
Submitted Date: September 20, 2006
Published Date: September 20, 2006
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.
Our basic argument is this: for-profit research ethics committees are in a client-provider relationship with study sponsors; this relationship creates a conflict of interest; and this conflict of interest is particularly dangerous under a weak regulatory system which does not prevent forum shopping and allows market criteria to influence committee selection. We use various examples of serious controversies to support our claim that there are flaws in the system. This seems more appropriate than using one or two 'good examples' to argue that the system works just fine. The claim by two for-profit IRBs that they manage to perform admirably despite this conflict of interest would not undermine our argument, even if independent evidence were given for the claim. (None is given here, of course.). Academic committees are certainly also affected by conflicts of interest. But that doesn't remove the conflict in for-profit review. The widely lauded system of accreditation is in our opinion a soft self-regulatory mechanism which does not fill the regulatory loopholes.
Lestou, Ondrusek and Blajchman are members of IRB Services, the for-profit IRB that approved the controversial immunosuppressant study conducted at an Anapharm research unit in Montreal. As we noted in our article, a number of subjects in that trial were infected with tuberculosis. IRB Services has been criticized for its review of this trial, including for not imposing basic TB screening of participants and for approving a backloaded payment structure intended to keep people in the trial. It is worth noting that Anapharm used at least one other prominent Canadian for-profit committee in the past, raising concerns about forum shopping.
We referred to WIRB in our article because WIRB is frequently lauded as setting the highest IRB standards. Thus it seems particularly relevant that even WIRB has had its share of problems. Our reference to the sheer number of reviews conducted by WIRB reflects our concern about the power of one commercial entity in the exercise of what we consider a fundamental public function. WIRB has become a state within the state when it comes to the protection of human subjects. Particularly in the absence of strict regulatory control, it is worth asking whether it is healthy to concentrate so much power over the protection of human subjects in the hands of one commercial enterprise.
Shamoo and Woeckner rightly point to the difficulty of gaining empirical evidence on IRBs. One of us conducted a survey of for-profit IRBs in 1997. While several committees collaborated well with this survey (including WIRB and IRB Services), much information remained hidden behind a veil of corporate secrecy. Regulatory agencies in Canada and the USA simply accept this secrecy. Some regulators even rely on the goodwill of IRBs to determine regulatory initiatives. When the FDA looked into the issue of IRB shopping, for example, it invited comments, received them primarily from those in the industry, and simply accepted the claim that IRB shopping was not a serious concern.
The idea of regional committees is indeed not new, as Shamoo and Woeckner indicate. They cite as first source an article of 1995. However, research ethics committees with exclusive territorial jurisdiction exist in several European countries since the late 1980s-early 1990s (e.g. France, Switzerland, Scandinavian countries). They have since been introduced in many more. Emanuel suggests that we have failed to make positive contributions to the debate on the organization of research ethics committees and contrasts that with his 2004 proposal for regional review boards. In fact, one of us (Lemmens) has argued since 1996 for improvements to the regulatory structure of Research Ethics Committees, including the introduction of regional committees, in scholarly journals[1, 3-7], at international conferences, and in a report for the European Union. Excerpts of one of these articles were reprinted in a text book on Research Ethics edited by Emanuel. We are pleased to know that with his 2004 article Emanuel has come to agree.
1. Lemmens T, Thompson A (2001) Noninstitutional Commercial Review Boards in North America: A Critical Appraisal and Comparison with IRBs. IRB: Ethics and Human Research 32(2):1-12.
2. Brainard F (2006) Federal Agency Decides Not To Regulate 'IRB Shopping', Saying the Research Dodge Appears to Be Uncommon. Chron. High. Ed. (January 18) Available at IRB Forum website
3. Lemmens T, Freedman B. (2000) Ethics Review for Sale? Conflict of Interest and Commercial Research Ethics Review Boards. Milbank Quarterly 78(4): 547-584
4. Glass KC, Lemmens T (1999) Conflict of Interest and Commercialization of Biomedical Research: What is the Role of Research Ethics Review? in Caulfield T, Williams-Jones B editors, The Commercialization of Genetic Research: Ethical, Legal and Policy Issues. New York: Plenum Press. pp 79-99
5. Hirtle M, Lemmens T, Sprumont D (2000) A Comparative Analysis of Research Ethics Review Mechanisms and the ICH Good Clinical Practice Guideline European Journal of Health Law 7: 265-292
6. Lemmens T (2005) Federal Regulation of REB Review of Clinical Trials: A Modest but Easy Step Towards an Accountable REB Review Structure in Canada Health Law Review (Special Issue on Research Governance, M. McDonald, ed.) 13(2-3):39-50
7. Caulfield T, Lemmens T, Kinsella D, McDonald M (2004) Research Ethics Review and the Role of Professional Bodies: A View from Canada. Journal of Law, Medicine & Ethics 32(2): 365-368.
8. Emanuel EJ, Crouch RA, Arras JD, Moreno JD, Grady C, editors (2003) Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Baltimore, MD: Johns Hopkins University Press. pp. 429-435.