RAC retreats a bit on adverse events

WASHINGTON - NIH's Recombinant DNA Advisory Committee (RAC) has stepped back from its demands that investigators immediately report to NIH all serious adverse events that occur in gene transfer trials, backing instead a proposal to require immediate reporting only of serious adverse events that are related to the gene therapy.

However, although the proposal calls for RAC to release the data to the public only in analytical reports, committee members were told last week that the recommended reporting procedures would put information about all serious adverse events from human gene transfer experiments into the public domain...