The Regulation of Conflicts of Interest in the Canadian Stem Cell Research Environment
Ogbogu, Ubaka, Health Law Review
The ethical dilemmas associated with conflicts of interest (COI) involving biomedical researchers and institutions is a familiar issue in research ethics. There has been a lot of discourse on the subject, and the main points can be summarized as follows. First, COI occur when "professional judgment concerning a primary interest (such as patient welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)." (1) Several types of COI exist, depending on the source or nature of the conflicting interest, (2) although it is generally agreed that financial COI are the most pervasive. (3) Second, if not managed or avoided, such conflicts can compromise research integrity, foster negative public perception of the research and jeopardize the welfare of research subjects. (4) Indeed, several high profile cases of COI in the past few years, including the notorious Olivieri and Healy incidents in Canada, have brought the problems posed by COI to the forefront of research ethics debates. (5) Third, the establishment of oversight mechanisms to deal with COI is considered imperative, and two key oversight models have been proffered in relevant literature. The first advocates prohibiting interests or situations that could potentially result in COI, (6) while the second requires management of such conflicts through disclosure and the process of peer review. (7) Institutional oversight policies are generally based on one or a combination of both models. (8)
Concerns about COI in the biomedical research environment are particularly significant for emerging technologies like stem cell research. Mere perception of COI involving stem cell researchers and/or other stakeholders could bring adverse public opinion and stifling regulatory scrutiny to the research. Also, as stem cell research moves from the laboratory to the clinical trial stage, it is imperative to eliminate or limit ethical pitfalls that could compromise the safety of research participants, and ultimately jeopardize research continuity.
Many of Canada's stem cell researchers receive research funds from the Stem Cell Network (SCN or Network), one of Canada's Networks of Centres of Excellence (NCE). (9) The SCN's primary operation is the redistribution of NCE and partner funds to researchers participating in the Network. By virtue of its NCE status, the SCN is responsible for the commercialization of Network-supported research and the management of research portfolios. The SCN is also mandated to maintain close association with private sector interests, both in terms of management and in meeting commercialization objectives. (10) The NCE/SCN funding structure therefore promotes relations between potentially conflicting interests, including academic research, corporate and public interests.
In Part 1, this background paper (11) examines actual and potential COI drivers within the stem cell research context, including a consideration of the nature and impact of the NCE program. Much of the discussion in this part examines the potential impact of commercialization in creating opportunities for COI. However, it is important to note that COI is one, and certainly not the only issue associated with the commercialization of research. Excellent reviews of the issues exist in relevant literature (12) and as such, do not warrant repetition in this paper. Part 2 reviews existing COI oversight policies applicable to the Canadian and international stem cell research context. This part also highlights gaps in COI oversight. In the final part, the paper offers recommendations for addressing identified gaps in oversight and policy.
a. The NCE Program, Stem Cell Network and the Commercialization Initiative
Canada's NCE program was established in 1989 to steer a "national system of innovation" aimed at linking scientific research with industrial know-how and commercial exploitation. …