Abstract
In this paper we briefly review the history of human clinical research in the United States, and describe the role that Institutional Review Boards (IRBs) have played. In particular, we describe the role of the IRB in clinical research involving the cognitively impaired. We emphasize the importance of further empirical research to elucidate the process of informed consent, surrogate decision-making, advance directives, and the role of the IRB, and suggest directions for future investigation.
Sommario
In questo articolo viene passata in rassegna la storia della ricerca clinica nell'uomo negli Stati Uniti e del ruolo giocato dagli Institutional Review Boards (IRBs), con particolare riferimento agli studi riguardanti i pazienti con deficit cognitivo. In questo settore viene enfatizzata l'importanza di ulteriori ricerche empiriche per meglio chiarire le procedure del consenso informato, del consenso sostitutivo, delle direttive anticipate, del ruolo degli IRBs e per suggerire indicazioni per il futuro.
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Siegler, M., Casarett, D.J. Ethical and legal issues of clinical research involving the cognitively impaired: the role of institutional review boards in the U.S.. Ital J Neuro Sci 18 (Suppl 5), 43–47 (1997). https://doi.org/10.1007/BF02048206
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DOI: https://doi.org/10.1007/BF02048206