ABSTRACT

In the months since the terrorist attacks of September 11, 2001, the clinical research community has faced the following two compelling and often competing agendas: a pressing need for improvements in the diagnosis, prevention, and treatment of neuropsychiatric consequences of catastrophic events; and an ethical mandate to prevent the exploitation of vulnerable research subjects who may not be able to act in their own best interests. It is ironic that for victims of disaster and many other human conditions most in need of empirical data to guide clinical care, there are substantial conceptual, ethical, and practical obstacles to conducting that research. How to facilitate the conduct of these important studies in accordance with the highest ethical standards and regulatory requirements was the focus of a conference sponsored by the New York Academy of Medicine and the National Institute of Mental Health, United States Department of Health and Human Services.