BioCentury
ARTICLE | Politics & Policy

NIH to reduce RAC's role

May 23, 2014 12:11 AM UTC

NIH Director Francis Collins said the agency will minimize the number of human gene transfer protocols that will be reviewed by the agency's Recombinant DNA Advisory Committee. NIH established RAC in 1974 to provide increased oversight of and a public forum to discuss recombinant DNA and gene transfer research. The committee provides recommendations to the NIH director on basic and clinical research involving recombinant or synthetic nucleic acid molecules. In a December 2013 report, the Institute of Medicine said the oversight roles of RAC, FDA and institutional authorities have become "overlapping and arguably redundant."

Collins said he will implement an IOM recommendation that NIH continue to register gene transfer protocols and refer protocols for additional public review only under a few circumstances. According to the IOM recommendation, RAC should continue to review protocols only if the review can't be adequately performed by other regulatory or oversight processes; and then only if the protocol meets at least one of following three criteria: the protocol uses a new vector, genetic material or delivery method that would be first-in-man; the protocol relies on preclinical safety data come from a new preclinical model system; or the vector, gene construct, or method of delivery is associated with possible toxicities. ...