RESEARCH WITH COGNITIVELY IMPAIRED SUBJECTS - UNFINISHED BUSINESS IN THE REGULATION OF HUMAN RESEARCH

In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued an important report that addressed the difficult ethical issues arising in research involving s ubjects with mental disabilities. However, because of irreconcilable c onflicts between the scientific community and rights-oriented advocacy groups, the federal government never issued the special regulations p ertaining to these issues that had been envisioned by the National Com mission. Because these important ethical issues have not yet been adeq uately addressed by policy-making bodies, protection of cognitively im paired subjects depends too heavily on the diverse ethical sensitiviti es of individual investigators and on ad hoc responses of particular i nstitutional review boards. Researchers should support a credible and authoritative process for reexamining and resolving ethical issues rel ating to research with cognitively impaired subjects. This can be acco mplished without leading to the stalemate that doomed the National Com mission's proposals. The challenge is to forge a consensus on ethical guidelines and safeguards that will most reasonably accommodate the go als of protecting the dignity and well-being of research subjects whil e avoiding undue impediments to valuable scientific inquiry.