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By Alan Sugar, MD
Professor of Medicine
Boston University School of Medicine
It took a report from the U.S. Department of Health and Human Services’ Office of the Inspector General1 to focus attention on an important but long-neglected aspect of the system to protect human subjects who participate in clinical studies. This was followed by a series of actions by the Office of Protection from Research Risks (OPRR) that resulted in the closing of research programs at a number of prestigious academic medical centers.
Numerous articles in the lay press sensationalized the current state of affairs in research oversight, and the death of a subject enrolled in a gene therapy study in Philadelphia seemed to encompass much of what is wrong with our current system of research oversight. Hardly a day now passes without some news reflecting deliberations of committees or new accusations of "wrongdoing" in the name of science.
In the midst of the sensationalism, IRBs must continue to fulfill their responsibilities to review and monitor clinical studies despite new obstacles. For example, the appearance of a new agency, the Office for Human Research Protections (OHRP), created an increased level of government scrutiny. The agency’s new director, Greg Koski, PhD, MD, presumably will bring new interpretations to existing regulations and a new implementation of their mission.
Currently, the National Bioethics Advisory Commission (NBAC), the Institute of Medicine, and other organizations are holding meetings designed to address a variety of issues relevant to the oversight of clinical research in the United States, including the structure and function of the IRB. In fact, an analysis of the recent meeting of the NBAC on its report on human research protection is included in this issue.
No doubt, recommendations derived from these deliberations will appear over the next several months. Your job as an IRB administrator is to ensure your IRB is in a position to quickly embrace the changes in mission, if any, and how your board conducts business.
It is more important than ever for IRB administrators and members to recognize what efforts are under way to modify the current oversight system and to stay abreast of the changes that may soon be proposed and implemented. Fortunately, a number of web sites make this possible, such as the OHRP web page and the NBAC web page. (See editor’s note for addresses.)
The purpose of IRB Advisor is to help you with the task of keeping up to date, provide you with information vital to your work, and provide expert commentary on the developments that affect human research subject protection. We encourage our readers to communicate directly with us and to share your thoughts as we enter this exciting but rapidly changing era in the history of human subject protections.
1. Office of Inspector General. Institutional Review Boards: A System in Jeopardy. Washington, DC; March 1998.