Persons Institutionalized as Mentally Disabled
Among the populations to be studied by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was that described as the institutionalized mentally infirm. Accordingly, as for other special subject populations described previously, the National Commission followed its usual series of contracted reports, public meetings and testimony, and commission debate to arrive at a set of proposed recommendations for HEW. In turn, HEW developed a set of proposed rules governing research with this population. Due at least in part to the freeze on government regulations, these proposed rules remain the ones for us to heed at present. It is not currently known whether these rules will be revised or made final by HHS in view of federal policy to limit regulatory activities and reduce government paperwork. In the author’s opinion, the proposed rules that do exist, as they appear appended to this chapter, should still serve as a useful guide for researchers in this area. Unless unusually substantial changes are made in the proposed rules, final rules (when published) should draw heavily on the proposed rules as appended to this chapter. Once again, the cautious researcher should consult federal agencies (e.g., the NIH Office for Protection from Research Risks) for current rules for this area still in a state of limbo.
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