Watching the watchdogs: negligence, liability, and research ethics boards.

Introduction Recent high profile incidents involving the death or injury of individuals participating in medical research projects have shaken confidence in the protections afforded human subjects of biomedical (1) In 1999, 18 year old Jesse Gelsinger died while participating in a clinical trial conducted by the University of Pennsylvania Institute for Gene Therapy. Jesse suffered from a mild form of a rare metabolic disorder called ornithine transcarbamylase deficiency (OTC). The experiment involved the injection of genetic material into Jesse's bloodstream using a viral vector. This triggered multiple organ system failure, ultimately bringing about Jesse's untimely death. (2) It was later revealed that the investigator may have stood to benefit financially from this research. In the complaint filed by the Gelsinger family, it was alleged that the researchers involved had used a virus vector known to be more dangerous than other vectors, because they held patents on that particular virus. (3) Along with other, similar incidents the Gelsinger case has thrust the problems associated with the regulation of clinical research into the spotlight. Among the numerous difficult issues raised by these cases is the matter of the potential liability of the institutional research ethics board (REB) with respect to adverse outcomes of particular trials. Are there standards of care for REBs? What constitutes negligence on the part of an REB? What happens when there is a conflict of interest at any stage of the research approval process? This paper examines the issue of REB liability for negligence in detail. In Part I, I explain what an REB is, and what the regulatory structure for human subjects research is like in Canada. In Part II, I discuss the problems associated with REBs, such as conflict of interest, using recent cases as illustrations. I also provide an analysis of the nature of liability and tort law with respect to REBs--for example, issues of duty of care, standards, and causation--with reference to existing jurisprudence. In Part III, I consider the advantages and disadvantages of using the tort system as a means of dealing with REB negligence. Finally, I discuss the recent regulatory reform initiatives in both Canada and the US, and examine the various recommendations that have been set forth with respect to improving REB functioning and accountability. Part I: REBs and The Regulation of Clinical Research in Canada a) Regulation in Canada: The Historical Context Research involving human subjects has changed dramatically over the last half-century. (4) Evidence of appalling experiments on human beings conducted by the Nazis, together with other reports of gross misconduct from around the world, prompted the creation of ethical guidelines for research with human subjects. The first international document stipulating voluntariness and informed consent as prerequisites for medical research on human subjects was the Nuremberg Code, established in 1948. (5) This was followed by the World Medical Association's Declaration of Helsinki in 1964, which articulated that informed consent from research participants is obligatory, and that the risks of research should not exceed the benefits. (6) In 1974, largely in response to fallout from the Tuskegee Syphilis Study (7), the US government passed the National Research Act, which created the US National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. (8) In 1979, the Commission released the Belmont Report, which pronounced three guiding principles for research: respect for persons, beneficence, and justice. (9) The Nuremberg Code, the Declaration of Helsinki, and the Belmont Report are the foundations for most laws and standards governing the protection of human subjects in medical research, including those of Canada. b) Regulation in Canada: Different Schemes for Different Jurisdictions While a more cohesive regulatory structure for research is currently under development, medical research involving human subjects in Canada is currently regulated differently across different jurisdictions due to the constitutional allocation of matters of health care, and property and civil rights to the provinces. …

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