NIH provides guidelines for investigators & institutions (such as universities & hospitals) to follow when conducting clinical trials with gene therapy.
B.
These guidelines state that clinical trials at institutions receiving NIH funding for this type of research must be registered with the NIH Office of Biotechnology Activities.
C.
The protocol, or plan, for each clinical trial is then reviewed by the NIH Recombinant DNA Advisory Committee (RAC) to determine whether it raises medical, ethical, or safety issues that warrant further discussion at one of the RAC's public meetings.
D.
NIH does not regulate gene therapy trials that are not funded by NIH.