Translating ethics into law: duties of care in health research involving humans.

Health Law ReviewVol. 13 Nbr. 2-3, March 2005

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Translating ethics into law: duties of care in health research involving humans.

In the field of health research, good governance has two primary goals: to ensure that the research conducted is scientifically valid, and that it is conducted in an ethical manner, protecting the physical and psychological integrity of the research participant. Since the emergence of research ethics boards (REBs) in Canada, responsibility for good governance is too often conflated with the responsibility for research review. Ideally, however, good governance results from an assumption of obligations by all those engaged in the research enterprise. Research ethics boards are not the sole repository of this responsibility. As a recent statement by medical journal editors pointed out: "In return for the altruism and trust that make clinical research possible, the research enterprise has an obligation to conduct research ethically and to report it honestly." (1) This statement applies not only to clinical research but equally to all types of research involving humans.

The first goal of this paper is therefore to identify the actors who make up the research enterprise and, very briefly, to sketch the nature of the role that each of them may play in the good governance of research involving humans. Some of thes...

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