June 22, 2001

NIH Proposes Expanding RAC Membership; Provides Update On COI Policies

At the June 14-15 meeting of the NIH Recombinant DNA Advisory Committee (RAC), Amy Patterson, Ph.D., director of the Office of Biotechnology Activities (OBA), proposed a plan to augment the membership and expertise of the RAC. As a result of the number and variety of gene transfer protocols, the Committee proposes to expand the number of members to ensure that the proper expertise is available. The RAC currently reviews an average of 25-30 protocols per quarter. The RAC also intends to use this opportunity to clarify its description, role, and function with respect to the NIH Guidelines. The proposed language to modify the RAC was accepted by the Committee at the meeting and will be submitted for public comment in the Federal Register.

Speaking on another topic at the meeting, Wendy Baldwin, Ph.D., deputy director for Extramural Research, NIH, provided an update of the NIH activities and policies surrounding conflict of interest (COI) and "research objectivity." Dr. Baldwin indicated that during the next year, her office plans to visit a number of institutions and develop a "best practices" guide on COI for research institutions. Although all research institutions receiving NIH funds are required to establish COI policies, Dr. Baldwin believes that institutions should do a better job of informing their investigators of these policies. She iterated that the establishment of COI and "research objectivity" policies should aid in the development of a network of protections for human subjects involved in research, which should include efforts by Institutional Review Boards, Institutional Biosafety Committees, Data Safety Monitoring Boards, and Institutional Compliance Offices. Activities among these entities are often quite specific, but they also need to be coordinated.

RAC members also heard presentations regarding:

• final action on amending the Safety Information Reporting Requirements of the NIH Guidelines,
• proposed action to modify specific E. Coli Risk Group Designations,
• development of the NIH/FDA Genetic Modification Clinical Research Information System (GeMCRIS) Database, and
• planning of the Institutional Biosafety Committee (IBC) Policy Conference

Information: Andrew Quon, AAMC Division of Biomedical and Health Sciences Research, 202-828-0485.