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The Many Forms of Consent

The Many Forms of Consent

(p.113) Five The Many Forms of Consent
Behind Closed Doors
Laura Stark
University of Chicago Press

This chapter examines the history of the forms of consents in the United States. It discusses the rules for proof of consent during the 1950s and 1960s and the opposition of National Institutes of Health (NIH) researchers to patient-generation documentation, even after the passage of the 1962 FDA Drug Act which placed the NIH under the regulatory purview of the Food and Drug Administration (FDA). It also describes the NIH designed group review to allow researchers to avoid consent documents.

Keywords:   forms of consents, United States, proof of consent, NIH researchers, FDA Drug Act, patient-generation documentation, group review

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