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The Journal of Bone and Joint Surgery 83:161 (2001)
© 2001 The Journal of Bone and Joint Surgery, Inc.

Editorial

Update on Human Rights Issues in Clinical Research

Albert H. Burstein, PhD and Marc F. Swiontkowski, MD

The concept of protection of the human rights of patients involved in clinical research studies by the use of informed consent and institutional review of test protocols is not new to these pages. We have, in the past, presented editorial opinion and policy, as well as a review of the subject in our Current Concepts Review section1. The process of protection of the human rights of experimental subjects continues to evolve through the mechanism of the Declaration of Helsinki as adopted by the World Medical Association. This international group met in October 2000 to clarify some issues concerning the allowable structure of experimental protocols when human research is combined with medical care. At issue was the acceptability of a classic study protocol that involves use of a placebo as a control in an experiment that is being performed to determine the safety and efficacy of an experimental treatment. Often . . . [Full Text of this Article]


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