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May 24, 1993

The Consent Form Revisited

Arch Intern Med. 1993;153(10):1170-1173. doi:10.1001/archinte.1993.00410100008002

IT HAS been more than a decade since the Code of Federal Regulations1 clearly defined the responsibility of the research investigator to obtain written consent from human subjects engaged in clinical trials. The "elements of consent" have been widely disseminated by various federal agencies concerned with the protection of human subjects engaged in research.2,3

Researchers, regulatory affairs experts, and institutional review board members possess more than a basic knowledge of consent requirements. Food and Drug Administration (FDA) fact sheets are readily available for reinforcement, and most hospitals circulate consent form prototypes as templates. Why, then, is the consent form the biggest stumbling block for most investigators? Why, in the face of easy, step-by-step instructions for the investigator, do most consent forms require two and three revisions? How can principal investigators be taught to view the consent form as a useful tool in educating prospective subjects rather than a

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