Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability
Caulfield, Timothy, Canadian Public Administration
Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability Edited by TRUDO LEMMENS and DUFF R. WARING. Toronto: University of Toronto Press. 2006. Pp. viii, 267, bibliographical references, index.
Biomedical research is big business. Whether it occurs in private industry laboratories, in the university setting or in the community clinic, money has become a dominant theme--money for research, money for patient recruitment, and the hope of lots of money once a new product or drug is ready for the market. Indeed, the defining characteristic of this era of biomedical research is the degree to which research is linked to industry interests. Increasingly, research is either carried out by industry or by university researchers with close ties to industry. Adding to this trend is the fact that the academic community is encouraged to build ties with industry. Virtually all of Canada's public research-funding agencies--from the Canadian Institutes of Health Research to Genome Canada to the National Centres of Excellence programs --have a commercialization agenda. Even the Social Sciences and Humanities Research Council, the agency that funds disciplines like philosophy, political science and history, has started to emphasize practical "knowledge translation."
The influence of industry is the dominant theme in a wonderful new collection edited by Trudo Lemmens (at the Faculty of Law, with a cross-appointment in the Faculty of Medicine, University of Toronto) and Duff Waring (at the Department of Philosophy, York University). Almost every chapter is built on the premise that the research environment has become increasingly commercialized, while existing research ethics policies and regulatory structures are poorly suited to the management of the ethical challenges created by this reality. The book rightly casts this trend as creating some of the most challenging ethics issues ever to face the research community.
The book begins with a powerful and heartbreaking account of the Jesse Gelsinger tragedy, written with balance and reserve by Jesse's father, Paul. The chapter provides the unique perspective of a man who lost his child to what can only be characterized as a failure of research governance. The Gelsinger story, which became an internationally renowned ethics scandal, is picked up in many of the chapters that follow and is used as an illustration of the potential impact of conflicts of interest, poor oversight and less than robust ethics review.
Many of the authors argue persuasively that the current situation is unacceptable, from both the perspective of research ethics and academic integrity. For example, Sheldon Krimsky's chapter, "The Ethical and Legal Foundations of Scientific 'Conflict of Interest,'" explores ethical foundations of our concern for conflicts of interest in the context of academic research. He notes that the increasing involvement with industry challenges the view of scientists as "selfless investigators of universal truth" (p. 64). While Krimsky recognizes that this perspective is premised largely on a myth, the chapter highlights the degree to which commercial interests are eroding the academic tradition and, perhaps, "the demise of objectivity" (p. 72). As such, he recommends, among other things, a clear separation of "those who produce knowledge in academia and those stakeholders who have a financial interest in that knowledge" (p. …