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Article
October 1983

Ethical and Legal Aspects of Clinical Trials

Arch Neurol. 1983;40(11):702. doi:10.1001/archneur.1983.04050100042016
Abstract

Our working committee was charged to examine and to make recommendations to the National Multiple Sclerosis Society (NMSS) concerning three broad areas of ethical import relevant to the design of therapeutic trials: (1) ethical problems inherent in the design of double-blind trials of new medications, (2) the role of pharmaceutical companies in the design of such trials, if any, and (3) the need for orphan-drug legislation, if any. Its recommendations follow.

DISCLOSURE  Anything short of full disclosure concerning the therapeutic trial is unethical. Accordingly, patients must be fully informed with regard to diagnosis, the nature of the trial, alternative therapies that are available, known risks involved in the trial, with emphasis on the more serious ones, and any other facts that a reasonable person might wish to consider before deciding to participate. All of this information should be on a written consent form, but there should also be clear

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