RESEARCH ON THE COGNITIVELY IMPAIRED - LESSONS AND WARNINGS FROM THE EMERGENCY RESEARCH DEBATE

OBJECTIVES: To demonstrate that the recent events in emergency researc h have broad implications for the conduct of human subjects research w ith 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 ar ticles, books, regulations, and court cases. RESULTS: The emergency re search controversy resulted in large part because of conflicting inter pretations of arguably inadequate research regulations. The proposed F ood and Drug Administration (FDA) regulations include advance informed consent, a broad role for family in approving a subject's participati on, replacement of a threshold of permissible risk, called minimal ris k, with a more sensible balancing of risks and benefits, and a role fo r the community in research approval. The current state of research on the cognitively impaired suggests that many of the same problems exis t now that existed in emergency research before the FDA issued its pro posed regulations. The ongoing case of T.D. et al. vs N.Y. State Offic e of Mental Health suggests that unless steps are taken similar to tho se taken in emergency research, much of clinical research on the cogni tively impaired could cease. CONCLUSION: Representatives of the govern ment, medicine, and the public must recognize the unresolved issues an d inadequate regulations relating to research on the cognitively impai red. The proposed FDA regulations for emergency research may provide g uidance for a settlement of these issues.