Regulacje i polityka gospodarcza · 22.11.1996

Recombinant DNA Research: Proposed Actions Under the Guidelines

On July 8, 1996, the NIH published a Notice of Intent to modify NIH's oversight of gene therapy. Specifically, the NIH proposed to: (1) Terminate the NIH Recombinant DNA Advisory Committee (RAC); (2) relinquish all approval responsibilities for recombinant DNA experiments involving human gene transfer to the Food and Drug Administration (FDA), which holds statutory authority for such approval; (3) establish the Office of Recombinant DNA Activities Advisory Committee (OAC); (4) limit the membership of OAC to 6-10 individuals, as compared to the 25 members appointed to the RAC; (5) regularly convene Gene Therapy Policy Conferences; and (6) continue the publicly available, comprehensive NIH database of human gene transfer clinical trials, including adverse events. The NIH received 71 written comments in response to the Notice of Intent, reflecting a broad range of opinions. After careful consideration of these comments, the NIH Director revised the proposal put forward in the July 8, Notice of Intent. This revised proposal, described herein as the Notice of Proposed Actions, reflects both public opinion and the NIH Director's intent to increase the effectiveness and efficiency of publ