September 01, 2000


letters to the editor

Research Subjects

While we were pleased to note the coverage provided in the July 21 Psychiatric News of the annual meeting panel chaired by Dr. Herbert Peyser in the article titled "When Can Incompetent Patients Be Research Subjects," we believe an important aspect of the panel was omitted. Dr. Barry B. Perlman focused his presentation on concerns about the everyday functioning of institutional review boards (IRBs). He took note of the frequent adverse news reporting about breaches in patient protections in the context of clinical research while also noting the public’s expectations for new research. He recognized that as the demands for more research exploded, clinical protocols were being carried out in community hospitals and even doctors’ offices well beyond the bounds of tertiary hospitals where such work was traditionally carried out.

The increasing variety of research settings and the enormous financial rewards attached to participation have created an environment in which an ethical slippery slope may have been fostered and "IRB shopping" occurs. In order to avoid increased cynicism towards clinical research with consequent wrongheaded law or regulation it was suggested that the public could be reassured by state departments of health and the JCAHO if they included reviews of IRBs and the charts of patients participating in research protocols as part of their inspections of hospitals and other health care organizations.

It was also suggested that consideration be given to the creation of regional IRBs as a means of addressing the incorporation of new technology into research and the fact of the decentralization of research itself.

While the above represent but two of several approaches presented at the symposium, there was a sense among the panelists that new strategies would be necessary to foster clinical research and at the same time assure participants that it is carried out within a safe framework. We believe that incorporating changes such as the above would result in the strengthening of the social structures necessary for gaining broad public support for the conducting of clinical research, which we want to see flourish.

Barry B. Perlman, M.D.

Vice President, New York State

Psychiatric Association

Herbert Peyser, M.D.

Area II Trustee