Washington

The US Department of Health and Human Services is to augment the panoply of government regulatory bodies by setting up a Secretary's Advisory Committee on Xenotransplantation (SACX) to oversee the technology.

The new committee will review proposed clinical trials and monitor ongoing trials, much as the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health (NIH) endorses novel gene-therapy protocols and monitors ‘adverse events’ in trials already under way.

But the role of the SACX in deciding which trials go ahead remains unclear. “There's been no decision yet on how it will work in terms of reviewing protocols,” says Mary Groesch, a policy officer at the NIH's Office of Biotechnology Activities who is handling nominations for the SACX.

The Food and Drug Administration (FDA) will have the final say in approving clinical trials. In gene therapy, it is the NIH director, and ultimately the FDA, which has the last word.

In the early 1980s, the RAC approved the first human clinical gene-therapy trial. By the 1990s, its responsibility was restricted to approving new types of protocol (see Nature 384, 297; 1996).

More recently, some critics have called for the RAC to stop examining new protocols altogether to focus on education, as the oversight of gene therapy by both the FDA and NIH has led to confusion, especially over reporting adverse events.

Researchers hope that, by sticking to a narrow mission, the SACX will attract less critical flak than the RAC.