In May 1991, Ian Rusted chaired a 2-day workshop sponsored by the National Council on Bioethics in Human Research (now the National Council on Ethics in Human Research) entitled “Ethics of Clinical Trials for Research Ethics Boards.”1 The participants were representatives of the pharmaceutical industry, the Medical Research Council of Canada, Health and Welfare Canada and the Royal College of Physicians and Surgeons of Canada, as well as members of research ethics boards from across Canada.
On reading the viewpoint by Lorraine Ferris and David Naylor,2 the spirited response by Salim Yusuf3 and the rebuttal by Ferris and Naylor,4 I experienced a sense of déjà vu: the points of view expressed in this exchange mirror the conclusions of the 1991 workshop. Unfortunately, although the Tri-Council drafting committee had access to the workshop recommendations for financial accountability and conflict of interest, they were not incorporated in the Tri-Council policy statement.5 The authors and CMAJ are to be commended for revisiting the subject.
At the heart of the matter are issues critical to both patient care and clinical research. Both of these activities are dependent upon public trust, which must be earned through openness and integrity.
Gerald A. Klassen Retired Physician Centreville, NS
Footnotes
Competing interests: Dr. Klassen is a past president of Canadian Society for Clinical Investigation and National Council on Ethics in Human Research.
References
- 1.Bioethics when undertaking clinical trials. In: Ethics of clinical trials for research ethics boards: proceedings of a national workshop. NCBHR Communiqué 1991;2(2):19-23. [PubMed]
- 2.Ferris LE, Naylor CD. Physician remuneration in inudstry-sponsored clinical trials: the case for standardized clinical trial budgets [editorial]. CMAJ 2004;171(8):883-6. [DOI] [PMC free article] [PubMed]
- 3.Yusuf S. Randomized clinical trials: Slow death by a thousand unnecessary policies? [editorial]. CMAJ 2004;171(8):889-92. [DOI] [PMC free article] [PubMed]
- 4.Ferris LE, Naylor CD. Rebuttal [editorial]. CMAJ 2004;171(8):892-3.
- 5.Tri-Council policy statement: ethical conduct for research involving humans. Ottawa: Medical Research Council of Canada; Natural Sciences and Engineering Research Council of Canada; Social Sciences and Humanities Research Council; 1998. Available: www.ncehr-cnerh.org/english/code_2/ (accessed 2005 Jan 5).