Subject comprehension, standards of information disclosure and potential liability in research.

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Medical research - Canada

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Subject comprehension, standards of information disclosure and potential liability in research.

I. Introduction

The history of modern research ethics can be traced to the ten articles of the Nuremberg Code, a response to the atrocities that Nazi physicians had perpetrated upon their hapless victims in so-called "medical experiments." Informed consent to research was the first and most prominent of those ten articles. In spite of this attempt to regulate human subjects research, however, some twenty years later Dr. Henry K. Beecher published a critical survey of twenty-two research projects conducted in the United States in the years subsequent to Nuremberg. (1) Beecher observed that in the vast majority of cases research subjects were never adequately apprised of the nature of the research conducted upon them. He reiterated the need for informed consent as a necessary component of morally acceptable research on human subjects. At the same time, however, he acknowledged that in practice it is often difficult to obtain adequately informed consent. Hence Beecher insisted on a second component in order for patients to be s afeguarded in the research process, namely "intelligent, informed, conscientious, compassionate, responsible investigators." (2)

There can be no doubt that the conduct of ethical research rests ultimately in the hands of persons of integrity. Yet Beecher's own investigations indicated that we would be foolish to assume this high standard is always or usually attained. In the years subsequent to Beecher's article a consensus has emerged that independent review of proposed research on human subjects is essential. This is the position set forth in the World Medical Association's Declaration of Helsinki, (3) and it serves as the historical basis of the contemporary Research Ethics Board (REB). Prior review by a duly constituted committee has become the ethical sine qua non of modem human subjects research.

Despite the widespread implementation of REB review, however, difficulties persist with regard to the matter of ensuring informed consent on the part of prospective research subjects. (4) The 1980 Supreme Court decision in Reibl v. Hughes (5) established the Canadian standard for informed consent to therapeutic treatment. However, the leading Canadian case for consent in the context of research and experimenta...

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