Challenges to Ethics Review in Health Research

Whereas Parliament believes that health research should ... take into consideration issues .... (1) The legislation creating the Canadian Institutes of Health Research (CIHR) in 2000 specifically mentioned ethics in the preamble (as noted above). This historic legislation first led the inclusion of an ethics member in boards across the Institutes and the creation of an Ethics Office within CIHR. Prior the creation of the CIHR, the Medical Research Council of Canada (MRC) had mandated ethics review and provided guidelines researchers since 1978. (2) Indeed, it was the MRC that provided the initial leadership in the creation of a Tri-Council committee prepare the 1998 Policy Statement on Ethical Conduct for Research Involving Humans. (3) This Statement is unique in that all ethics review of research involving human beings, whether in the social sciences, the humanities, engineering or the pure sciences, were regrouped together. While well-intended, logical and unifying, this approach has had unintended consequences in the social sciences and the humanities. (4) The National Council on Ethics in Human Research created in 1989 has as its mandate to provide leadership in advancing the knowledge and practice of the conduct of research involving humans through advice, guidance and education stakeholders. (5) Yet, in spite of all this guidance in health research ethics, there are problems concerning the need share and access data as exemplified by the report of the CIHR's task force on privacy. (6) The other federal initiative that came fruition after a decade of discussion and a Royal Commission is the law on assisted human reproduction and related research. (7) Again, the principles underscoring this legislation mention Parliament's ethical concerns as justifying certain prohibitions. (8) This legislation has far-reaching potential, well-beyond the prohibited criminal activities. Indeed, the federal regulatory powers extend the Agency created by the Act, which has amongst its objectives identify issues (s. 18(1)) and foster the application of principles (s. 22). (9) It is against this background, and that of further provincial legislative and overlay for biomedical research, that Canada's health research community attempts fulfill its desire advance research and yet protect participants through ethics review. Moreover, increasingly international norms also come into play as the Canadian research community becomes part of consortia that cross borders and share data and research tools. This latter and very recent phenomenon is not without influence on the nature and impact of ethics in health research. Indeed, it may well be time examine the role of ethics review in Canada as research becomes increasingly international and collaborative in terms of the research teams themselves and the data and tissue samples they seek share. Furthermore, as we will see, the principles underlying international projects particularly in population genomics research (while not denying the importance of autonomy and privacy), center on the values of solidarity and equity (10) and consider international databases as global public goods. (11) This paper will focus first on a discussion of the literature on the nature and role of ethics review generally and in Canada (i) and second, on the confounding factor of the international nature of modern health research on the underlying principles that have governed review until now (ii). (i) Nature & Role of Ethics Review Since the revision of the Declaration of Helsinki (12) in 2004, increasing attention has surrounded the discussion on the role of commercialization, the use of placebos, the return of research (as opposed clinical research) results and on the biobanking of tissues and DNA, especially at the level of populations. The latter topic in particular, where confined sampling in defined and identifiable populations such as aboriginal peoples, has resulted in the CIHR adopting guidelines specific this population. …

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