NIH Issues Statement on Reduced Special Review of Gene Therapy Clinical Trials

Eric Dorman

With recent advances in gene therapy and general public support for genetic research, it’s easy to forget that only a few decades ago genetic testing was highly controversial. Concerns over the ethical issues at stake in these clinical trials led to the creation of the Recombinant DNA Advisory Committee (RAC) in 1974, which provided extra oversight of genetic research. However, forty years of experience and advances in research methods have combined with an increased desire to reduce redundancies in the approval process to bring about a reconsideration of RAC’s role.

In a May 22 statement from NIH Director Francis S. Collins, he announced that with the exception of special cases, additional approval from RAC will not be necessary for gene therapy clinical trials. The decision is based on an NIH-commissioned study by the Institute of Medicine (IOM), which concluded that gene therapy clinical trials were subject to unnecessarily overlapping oversight processes. Advocates for the change also argue that these clinical trials are usually no different from other clinical trials that require less oversight.

Read the NIH statement here.

Read more from Science here.