NIH Guidelines on Research with Human Subjects
Certain classes of persons have limited capacity to consent to their involvement in experimental activities. Recognizing this, the Department of Health, Education, and Welfare, through the National Institutes of Health (NIH), appointed a special study group to review and recommend policies for the protection, in biomedical and behavioral research, of children, prenatal beings, prisoners, and the institutionalized mentally disabled. On November 16, 1973, the NIH published a document entitled “Protection of Human Subjects: Policies and Procedures” (hereafter called NIH original guidelines). This was a draft working document upon which the public was invited to comment. After comments were received and considered, a revised version of the original document was published, with public comment again being solicited. Once comments upon this document had been received and evaluated, a final set of recommendations would have been drafted and sent to the Secretary of Health, Education, and Welfare for promulgation as guidelines governing human research in the United States.
KeywordsPregnant Woman Premature Infant Human Ovum Ethical Advisory Protection Committee
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