These local review boards provide an opportunity for the general public to become involved in the decisions made about research involving gene therapy for human patients. Further, the NIH Guidelines for Research Involving Recombinant DNA Molecules encourage research facilities to open their IBC meetings to the public. At the national level, the Director of the NIH must approve each human gene therapy proposal. The initial review of the proposal is performed by the RAC's Human Gene Therapy Subcommittee, which is guided by the Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA into the Genome of Human Subjects , discussed later in this document. The general public is represented on the RAC and the Human Gene Therapy Subcommittee, as well as on the local review boards.
All meetings are to be open to the press and the public.
The NIH has authority only over certain federally funded research. However, many private companies that do not receive federal support voluntarily submit proposals to NIH for review. Since the 1970s, general interest in human gene therapy has increased both here and abroad, along with awareness of the need for oversight and regulation. The Guidelines for Research Involving Recombinant DNA Molecules were published in 1976. In 1978, the Guidelines were revised, relaxing many of the requirements for recombinant DNA experiments.