Recombinant DNA Advisory Committee (RAC)

The RAC is a panel of up to 21 national experts in various fields various fields of science, medicine, genetics, ethics, and patient perspectives that considers the current state of knowledge and technology regarding recombinant DNA research. A key role of the RAC is to advise the NIH Director and the NIH Office of Biotechnology Activities (OBA), which is the NIH locus of oversight for recombinant DNA research. In this capacity, the RAC recommends changes to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), which outline responsible research practices in basic and clinical recombinant DNA research.

Another important RAC function is to review research proposals involving human gene transfer research, or "gene therapy" as it is often called. All human gene transfer trials occurring at or sponsored by institutions receiving NIH funds for recombinant DNA research must be submitted to OBA for review by the RAC.

On June 20, 2007, the RAC hearing was met with unanimous Approval. Special Thanks to Drs. Michel Sadelain, Farid Boulad, Chris Ballas and the rest of our researchers and supporters. FDA approval is on the horizon. The Orphan Disease Project Team that appeared before the committee appears below.