The government has been slow to address itself to the question of monitoring ongoing research. In 1966 the Surgeon General acting on the Kefauver-Harris amendments of 1962, requested, and most research publications in turn required, investigators’ assurances that informed consent had been obtained. In the 1971 Institutional Guide to HEW policy, IRBs were charged with establishing a basis for continuing review in keeping with initial review determinations of risk/benefit, rights and welfare of subjects and informed consent. In 1974 HEW (Federal Register, section 46.2(4), Volume 39, No. 105, p. 18917) stipulated that where the board “finds risk is involved ..., it shall review the conduct of the activity at timely intervals.”
KeywordsConsent Form Consent Process National Commission Institutional Review Committee Review Mechanism
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