Zooming Through Review: RAC Steps Out Of The Way

While scientists debate how the National Institutes of Health should allocate gene therapy dollars, the agency is quietly moving out of routine clinical-protocol review. In December, an ad hoc committee of biomedical experts appointed by NIH director Harold Varmus gave a formal stamp of approval to the changes. NIH's Recombinant DNA Advisory Committee (RAC) is a panel of 14 independent scientists and nine public representatives. For years, RAC has reviewed gene therapy protocols by any research

Kathryn Brown
Feb 18, 1996
While scientists debate how the National Institutes of Health should allocate gene therapy dollars, the agency is quietly moving out of routine clinical-protocol review. In December, an ad hoc committee of biomedical experts appointed by NIH director Harold Varmus gave a formal stamp of approval to the changes.

NIH's Recombinant DNA Advisory Committee (RAC) is a panel of 14 independent scientists and nine public representatives. For years, RAC has reviewed gene therapy protocols by any researcher or organization receiving NIH funding.

But last summer, RAC-under pressure from researchers anxious to speed the regulatory process-decided to stop case-by-case review of gene therapy protocols. Instead, RAC decided to review only those protocols that depart from the familiar-for example, gene therapy attempted in utero or with a new vector.

At the same time, the ad hoc committee, led by geneticist Inder Verma of the Salk Institute in La Jolla, Calif., was working on...