Washington University Medical Center, Human Studies Committee
Submitted by: Dr. Philip Ludbrook and Dr. John Csernansky, Associate Dean and Director, HSC and Gregory B. Couch Professor of Psychiatry, Washington University School of Medicine

The following information was submitted on behalf of the candidate for the award. The Institute may have edited the text for presentation purposes. Health Improvement Institute has not verified, and does not guarantee, the completeness or accuracy of the information for any purpose.

Description: The Guidelines for the Evaluation of Studies in Persons with Psychiatric Illnesses is a report from the Washington University School of Medicine Human Studies Committee (HSC) Task Force on Psychiatric Research. This report offers guidelines for evaluating protocols involving persons with psychiatric diseases as well as contributing to the ongoing discussion within the research community concerning increasing consensus on ethical research in persons with psychiatric illnesses.

Significance/contribution: The Guidelines first provide a course of action for IRB reviewers and investigators involved in psychiatric research, when no such specific federal guidelines are available to protect this vulnerable population. These guidelines provide a one-of-a kind workable mechanism to allow appropriate and necessary risk-benefit analysis of research protocols, while strengthening the protections for individual research participants. Finally, these guidelines are a guide for researchers to follow to help them evaluate the ethics of individual trials, thus promoting increased awareness and a necessary consciousness of the ethical treatment and consideration that should accompany research involving special populations.

Impact: The impact of these guidelines can be measured by their potential to affect countless individuals involved in the protection of human subjects, and specifically those subjects considered to be a part of special populations. Because the guidelines are available and accessible to researchers in and outside of Washington University, via the HSC website, these guidelines have the potential to influence thousands of decisions concerning how to approach and conduct psychiatric research. The guidelines biggest impact would be on the researchers and or practitioners in helping them thoughtfully approach the controversial issues involved in conducting psychiatric research.

Innovators: The innovators of the Guidelines for the Evaluations of Studies in Persons with Psychiatric Illnesses are a group of individuals specifically selected for this project because of their expertise. They were: John G. Csernansky, M.D., Rebecca Dresser, J.D., Carl J. Fichtenbaum, M.D., Helen Kornblum, M.S.W., Philip A. Ludbrook, M.D., John W. Newcomer, M.D., Patricia M. Scannell, William D. Shannon, Ph.D., Richard D. Stevenson.

Applicant’s justification for award: These guidelines are dedicated to increasing investigators’ as well as reviewers’ knowledge of the ethical considerations needed when conducting and reviewing psychiatric trials. On a broader scale, these guidelines are a model of a workable mechanism which can help guide appropriate risk-benefit analysis of research protocols for any vulnerable populations, increasing protections to research participants and translating to improvements in the quality and productivity afforded vulnerable populations by America’s health care.


For additional information:
Dr. Philip Ludbrook and Dr. John Csernansky
Tel: 314-633-7400
Fax: 314-362-3047
Email: fuesse@msnotes.wustl.edu