Challenges to Ethics Review in Health Research (Canada‪)‬

"Whereas Parliament believes that health research should ... take into consideration ethical 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 to the inclusion of an ethics member in boards across the Institutes and the creation of an Ethics Office within CIHR. Prior to the creation of the CIHR, the Medical Research Council of Canada (MRC) had mandated ethics review and provided guidelines to researchers since 1978. (2) Indeed, it was the MRC that provided the initial leadership in the creation of a Tri-Council committee to 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 ethical conduct of research involving humans through advice, guidance and education to stakeholders." (5) Yet, in spite of all this guidance in health research ethics, there are problems concerning the need to share and access data as exemplified by the report of the CIHR's task force on privacy. (6) The other federal initiative that came to 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 to the Agency created by the Act, which has amongst its objectives to identify ethical issues (s. 18(1)) and to foster the application of ethical principles (s. 22). (9)