http://www4.od.nih.gov/oba/rac/cover.htmOversight of government-funded experiments involving gene therapy for human patients occurs at both the local and national levels.At the local level, facilities at which experiments would take place are required to have two types of committees. First, hospitals and universities involved in experiments with human subjects are required to have Institutional Review Boards (IRB) to ensure that the research complies with Department of Health and Human Services (DHHS) regulations for protection of human subjects. Second, experiments that involve gene insertion must be approved in advance by an Institutional Biosafety Committee (IBC). 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. The DHHS regulations require that at least one nonscientist serve as a member of each IRB. Further, the NIH Guidelines for Research Involving Recombinant DNA Molecules
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Human Gene Therapy Subcommittee, Gene Therapy Subcommittee