Challenges to ethics review in health research.

AuthorKnoppers, Bartha Maria

"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)

It is against this background, and that of further provincial legislative and ethical overlay for biomedical research, that Canada's health research community attempts to fulfill its desire to 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 to 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 to share. Furthermore, as we will see, the ethical 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 ethical 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 to clinical research) results and on the biobanking of tissues and DNA, especially at the level of populations. The latter topic in particular, where confined to sampling in defined and identifiable populations such as aboriginal peoples, has resulted in the CIHR adopting guidelines specific to this population. (13)

Ethics review in Canada has also been influenced by the adoption in 2000 of the Personal Information Protection and Electronic Documents Act (PIPEDA), (14) as well as the adoption of provincial legislation specific to personal information in the health care sector. (15) As already mentioned, the CIHR itself undertook a study of Best Practices for Protecting Privacy in Health Research. (16) An ongoing evaluation of the contents of the Tri-Council Policy Statement by the Interagency Advisory Panel on Research Ethics (17) as well as a move towards the consideration of multi-centered ethics review (18) are influencing the role and nature of ethics review.

In the decade following the adoption in 1998 of the Tri-Council Policy Statement, there has been an integration of multidisciplinary ethics review in both publicly and privately funded research. (19) Not only have professional societies adopted increasingly specific codes of conduct, (20) but funding bodies (e.g. Genome Canada) themselves have insisted on the integration of ethics in applications for...

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