Federal Regulation of REB Review of Clinical Trials: A Modest but Easy Step towards an Accountable REB Review Structure in Canada
Lemmens, Trudo, Health Law Review
Introduction: REB Review as Public Mandate
In 2000, a working group on the regulation of clinical trials, established by the Swiss Intercantonal Drug Regulatory Agency submitted a report on the regulation of clinical trials in the country, focusing in particular on the role and regulation of research ethics boards (REBs). (1) The working group had been established in the wake of a controversy surrounding a contract research organization, VanTx, and a private REB, the Freiburger Ethik-Kommission International (FEKI). This controversy hit the Swiss media after an Estonian newspaper reported that VanTx had been importing research subjects into Switzerland from foreign countries, and was often using highly questionable recruitment procedures. The report of the Working Group confirmed that serious problems were associated with the recruitment of subjects in phase I and II trials organized by VanTx. It found that VanTx had been flying subjects in from Estonia, Poland, Macedonia and the Slovak Republic, and that it had also targeted asylum seekers to participate in research in exchange for a participation fee. The report raised concerns about the consent procedures and about the focus on the recruitment of vulnerable people. (2) Interestingly, the report also revealed administrative concerns related to VanTx and FEKI. The director of VanTx appeared to combine this function with his position as director of the local subsidiary of FEKI, the REB that was approving the questionable research of his company. (3)
Following the VanTx scandal, the Cantonal Authorities of Bale decided to intervene by introducing the requirement that any research involving human subjects had to be reviewed by a recognized regional ethics review board, thereby making it impossible for the local subsidiary of FEKI to continue its work. FEKI challenged that decision in court and argued that the government had no authority to regulate REB review. In 2003, the Swiss Supreme Court (Bundesgericht) confirmed that the cantonal authorities have the authority to assign exclusive authority to a regional research review board, thereby depriving private REBs within their jurisdiction of their authority to operate. The highest court ruled that the organization of research review is part of the cantons' legitimate exercise of state authority in matters of health protection. Although it did not rule out a role for private parties in this system, it explicitly stated that they could only do so under explicit delegation of authority from the health authorities. "A research ethics committee fulfills a control function with a mandate from the state," the court ruled, "and the exercise of such function should not be open to whoever is interested." (4)
This case is, even in the international context, one of the rare court decisions that touch on the role of REBs and their relation to state authority. It confirms that REBs are seen as having an important public mandate with respect to health protection, and is therefore interesting as an introduction to a legal analysis of the basis for regulatory authority over REBs in Canada.
In this paper, I will argue that a clear governmentally-enforced regulatory structure around REB review is not only needed, but also relatively easy to accomplish in at least one area. A clear, accountable and independent REB system is particularly needed, I will suggest, in the context of clinical research involving new drugs and medical devices. The federal government, I will maintain, should have no difficulty imposing a binding regulatory regime around REB review in the context of such clinical trials. Various recent controversies have illustrated the serious concerns associated with the increasingly competitive context in which clinical trials are conducted. Interestingly, these controversies also confirm that the federal government can legitimately impose a regulatory structure which clearly could be qualified as a bona fide exercise of their public authority over the protection of the health and safety of its citizens. …