Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability.

Caulfield, Timothy

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. 78).

James Robert Brown takes this recommendation a step further. In his chapter, entitled "Self-Censorship," he explores the evidence regarding consequences of commercialized research. Like Krimsky, he views the issues through the lens of scientific integrity. He notes that many of the critiques of the commercialization trend "focus on moral improprieties, such as a lack of informed consent." However, Brown's focus is "the quality of scientific knowledge, not the mistreatment of people in acquiring it" (p. 85). He concludes that the scope and complexity of the issues demand a radical step--that is, a return to a research model that is dominated by public funding. His call for "socialized research" has intuitive appeal, though it is likely a reform option with little political appeal--a reality Brown readily admits.

Other chapters provide more modest, but more attainable, reform suggestions. For example, Lorraine Ferris and C. David Naylor, in "Promoting Integrity in Industry-Sponsored Clinical Drug Trials: Conflict of Interest for Canadian Academic Health Sciences Centres," explore the issues associated with industry-sponsored drug trials in the context of the Canadian regulatory environment. They conclude with recommendations about how to improve local and national conflict-of-interest guidelines. The chapter by Kathleen Glass, "Questions and Challenges in the Governance of Research Involving Humans: A Canadian Perspective," which provides a nice short overview of current governance schemes and the related ethics issues, touches on similar reform themes.

More consistency in the tone, style and approach of the chapters would have helped the flow of the book. Some chapters feel like short summaries of previous work, while others are quite in-depth and thorough (such as the wonderful chapter by Lemmens and Paul Miller, "The Human Subjects Trade: Ethical, Legal, and Regulatory Remedies to Deal with Recruitment Incentives and to Protect Scientific Integrity," on the recruitment of research participants). Also, it would have been nice to have a bit more diversity in the perspectives. All of the authors are (understandably, perhaps) highly suspicious of industry and the adequacy of the current regulatory regime. A perspective from industry might have provided balance and helped to frame the relevant debates. That said, all of the chapters are accurate, wonderfully written, and packed with useful information. Indeed, the book is both an academic analysis of research ethics issues and a nice informational resource on the current research and regulatory environment.

There are understandable justifications for the ongoing enthusiasm for industry-researcher collaborations, including the generation of more research dollars, the creation of jobs, and the facilitation of knowledge translation. But there is no doubt that these collaborations come at a significant social cost. This collection of essays provides needed insight into the scope, urgency, and complexity of those costs, and provides thought-provoking and fearless recommendations on how the current situation can be improved.

Timothy Caulfield is Canada Research Chair in Health Law and Policy and professor in the Faculty of Law and School of Public Health at the University of Alberta.