Research on the cognitively impaired: lessons and warnings from the emergency research debate.

OBJECTIVES: To demonstrate that the recent events in emergency research have broad implications for the conduct of human subjects research with the cognitively impaired. This essay illustrates the similarities between the two kinds of research and suggests how understanding these similarities might help to resolve issues in human subjects research on the cognitively impaired.
METHODS: A review of pertinent journal articles, books, regulations, and court cases.
RESULTS: The emergency research controversy resulted in large part because of conflicting interpretations of arguably inadequate research regulations. The proposed Food and Drug Administration (FDA) regulations include advance informed consent, a broad role for family in approving a subject's participation, replacement of a threshold of permissible risk, called minimal risk, with a more sensible balancing of risks and benefits, and a role for the community in research approval. The current state of research on the cognitively impaired suggests that many of the same problems exist now that existed in emergency research before the FDA issued its proposed regulations. The ongoing case of T.D. et al. vs N.Y. State Office of Mental Health suggest that unless steps are taken similar to those taken in emergency research, much of clinical research on the cognitively impaired could cease.
CONCLUSION: Representatives of the government, medicine, and the public must recognize the unresolved issues and inadequate regulations relating to research on the cognitively impaired. The proposed FDA regulations for emergency research may provide guidance for a settlement of these issues.