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Toward effective Canadian public–private partnerships in health research

Dr. Bernstein is President, Canadian Institutes of Health Research, Ottawa, Ont.

In a recent editorial on researcher–university–industry research contracts, CMAJ calls for further study and guidance on issues affecting clinical research in this country.¹ Indeed, it recognizes the need for leadership in promoting and monitoring "ethical behaviour in research."

As Canada's lead federal health research agency, the Canadian Institutes of Health Research (CIHR) has a responsibility to promote and ensure ethical conduct in research, a responsibility that it has vigorously embraced since its establishment. The significant growth in industry support for research over the past 10–20 years has greatly strengthened health research efforts in this country, as well as our potential to translate research findings into improved health for Canadians. At the same time, all partnerships bring with them their own challenges of establishing shared vision, goals and standards of research.

In early 2001, CIHR's Governing Council established a national Working Group on Partnerships co-chaired by Dr. Matthew Spence, President and CEO of the Alberta Heritage Foundation for Medical Research, and Dr. Michel Bureau, Président and CEO, Fonds de recherches en santé du Québec, and including representatives of other agencies and, importantly, of industry.² That working group's report emphasized core values of freedom of inquiry, dissemination of research results, integrity of research, sensitivity to conflict-of-interest issues, accountability and transparency, and the paramount importance of the public interest as an essential element of publicly supported research. CIHR and CMAJ also co-sponsored a meeting of editors of Canadian peer-reviewed health sciences journals in November 2001 to promote and enhance discourse regarding the ethical issues involved in research, dissemination of results, editing and publication.³

These activities complement the ongoing consideration of ethical issues within each of CIHR's 13 institutes, its entire research portfolio and its Governing Council, and reflect the foundational values and framework driving our approach to partnerships within the larger health research community. CIHR is committed to building on these initiatives in order to develop a robust program of research on ethics, the objectives of which are to achieve greater clarity and consistency in the ethical principles governing health research practices.

Looking forward, and as advocated by CMAJ, CIHR is planning to support an analysis of Canadian practices following a recent US study that surveyed investigator independence and subject protection in contracts between health research institutions and industrial sponsors.⁴ This study was carried out in response to updated guidelines issued by the International Committee of Medical Journal Editors (ICMJE),⁵ a distinguished group of editors of leading medical journals. Instituting a similar study for our own health research centres and health sciences faculties will provide important insights into the Canadian context in which our health research occurs.

CIHR continues to work through the Interagency Advisory Panel on Research Ethics and the Secretariat on Research Ethics to ensure that the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans⁶ reflects the core values described here. We will join with the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC) to ensure that the Memorandum of Understanding on Roles and Responsibilities in the Management of Federal Grants and Awards,⁷ which describes the roles of these federal agencies and the institutions that receive such federal funds, adequately deals with issues such as conflict of interest, communication of research results and patient informed consent. CIHR will also consult with key stakeholders involved in research partnerships and will revise its own guidelines and policies to deal with issues such as clinical trial design and access to and interpretation of data, so that publications from the full range of trials and other types of study funded by CIHR meet the ICMJE criteria.

We recognize that these are complex issues involving many players, and during this process we welcome suggestions as to how CIHR, in concert with others, can work to address these challenges. CIHR is committed to a clear, constructive and transparent process that is designed to protect human subjects and the public interest, while fulfilling our mandate to support public–private research partnerships that advance the health of Canadians.

Footnotes

Competing interests: None declared.

Correspondence to: Dr. Alan Bernstein, Canadian Institutes of Health Research, 410 Laurier Ave. W, Ottawa ON K1A 0W9; fax 613 954-1802; abernstein{at}cihr-irsc.gc.ca

References

1. The controlling interests of research [editorial]. CMAJ 2002;167(11):1221, 1223. [Free Full Text]
2. CIHR Working Group on Partnerships. Final report of the working group on partnership. Available: www.cihr-irsc.gc.ca/publications/about_cihr/partner_wrk_grp_report_e.pdf (accessed 2002 Dec 30).
3. Hoey J. Publication ethics. CMAJ Available: www.cmaj.ca/misc/ethics/publicationethics.shtml (accessed 2002 Dec 16).
4. Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, et al. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med 2002;347(17):1335-41.[Abstract/Free Full Text]
5. Davidoff F, DeAngelis CD, Drazen JM, Nicholls MG, Hoey J, Højgaard L, et al. Sponsorship, authorship and accountability [editorial].CMAJ 2001;165 (6):786-8.[Free Full Text]
6. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council policy statement on ethical conduct for research involving humans. Ottawa: Medical Research Council of Canada; 1998. Available: www.nserc.ca/programs/ethics/english/policy.htm (accessed 2002 Dec 31).
7. Canadian Institutes of Health Research, Social Sciences and Humanities Research Council of Canada, Natural Sciences and Engineering Research Council of Canada. Memorandum of understanding on the roles and responsibilities in the management of federal grants and awards. Available: www.nserc.ca/institution/mou_e.htm (accessed 2002 Dec 30).

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