Increased Federal Oversight of Human Subjects Research Is Focus of GNYHA Briefing

On September 22, 2000, GNYHA held a briefing for its members on the recent reorganization of the Federal Office of Protection from Research Risks (OPRR), within the U.S. Department of Health and Human Services, and on key issues that are part of a major new Federal initiative to increase oversight of human subjects research. In May 2000, President Clinton announced that the Federal government would strengthen oversight of human subjects research in several areas, including training for investigators, monitoring of clinical trials, and policies on conflicts of interest in research. Nancy Dubler, Director of the Division of Bioethics at Montefiore Medical Center and Co-chair of the Federal committee that recommended the reorganization of OPRR, spoke at the briefing. She discussed recent Federal enforcement actions to close research programs at major medical centers, including Duke and Penn University hospitals. She also examined the new Office of Human Subject Protections and the heightened focus on conflicts of interest in research as a result of the increased collaboration between academic medical centers and private industry, and the intense media scrutiny of this issue. As requested by participants at the briefing, GNYHA's focus at future briefings will be on legal requirements regarding conflicts of interest and model institutional policies. GNYHA has previously provided briefings for members on Federal regulations, compliance, and billing practices in this area.
 
 

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