Center for Biomedical Ethics Receives Grant to Develop Guidelines for Surgical Experiments
22 May 2002
The University of Virginia Center for Biomedical Ethics has received a $180,000 grant from the Greenwall Foundation to develop ethics guidelines for experimental surgery.
The question when innovative surgical procedures become experiments that require the patient's informed consent is a complex one for which there are no recognized standards. Unlike new drugs and devices, research involving novel surgical techniques are not regulated by the U.S. Food and Drug Administration.
Controlled studies of surgical procedures are critically important. Every year thousands of people undergo surgery utilizing techniques of unproven worth. Clearer ethical standards will aid surgeons in the design of critically important research studies.
Surgeons often need to adapt their techniques to unique patient anatomy or to the individual's manifestation of a disease. Sometimes, however, a maneuver or method may be applied to a series of patients in a more or less deliberate manner. At some point the series may be transformed from a group of patients to a set of research subjects. At what point that may be said to occur, and what ethical rules should apply to this process, are the issues that this project will examine.
The principle investigators for this project are Jonathan D. Moreno, Ph.D., and Angelique Reitsma, M.D. Dr. Moreno is the Kornfeld Professor and Director of the Center for Biomedical Ethics. He is an internationally recognized authority on the ethics and history of clinical trials. Dr. Reitsma is a research associate in the Center and a graduate student in the M.A. program in bioethics. She has taught bioethics at the Utrecht University in The Netherlands, where she earned her medical degree.
Drs. Moreno and Reitsma have already published the results of a pilot survey of surgeons who have published reports on their innovative surgery. Their paper, which appears in the June 2001 issue of the Journal of the American College of Surgeons, demonstrates the wide diversity of opinion on these issues.
In developing the proposal that led to this award the center received the support of the ethics committee of the American College of Surgeons (ACS). The center will cooperate with the ACS and prominent surgeons to develop an informed and practical set of guidelines that will be widely disseminated in the surgical community.