title: NIH oversight of human gene transfer research involving retroviral, lentiviral, and adeno-associated virus vectors and the role of the NIH recombinant DNA advisory committee.
abstract: In response to public and scientific concerns regarding human gene transfer research, the National Institutes of Health (NIH) developed a transparent oversight system that extends to human gene transfer protocols that are either conducted with NIH funding or conducted at institutions that receive NIH funding for recombinant DNA research. The NIH Recombinant DNA Advisory Committee (RAC) has been the primary advisory body to NIH regarding the conduct of this research. Human gene transfer research proposals that are subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) must be submitted to the NIH Office of Biotechnology Activities (OBA), and protocols that raise novel scientific, safety, medical, ethical, or social issues are publicly discussed at the RAC's quarterly public meetings. OBA also convenes gene transfer safety symposia and policy conferences to provide a public forum for scientific experts to discuss emerging issues in the field. This transparent system of review promotes the rapid exchange of important scientific information and dissemination of data. The goal is to optimize the conduct of individual research protocols and to advance gene transfer research generally. This process has fostered the development of retroviral, lentiviral, and adeno-associated viral vector mediated gene delivery.
authors.affiliation: Office of Biotechnology Activities, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Marina
authors.initials: M
authors.lastname: O'Reilly
authors.forename: Allan
authors.initials: A
authors.lastname: Shipp
authors.forename: Eugene
authors.initials: E
authors.lastname: Rosenthal
authors.forename: Robert
authors.initials: R
authors.lastname: Jambou
authors.forename: Tom
authors.initials: T
authors.lastname: Shih
authors.forename: Maureen
authors.initials: M
authors.lastname: Montgomery
authors.forename: Linda
authors.initials: L
authors.lastname: Gargiulo
authors.forename: Amy
authors.initials: A
authors.lastname: Patterson
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Corrigan-Curay
mesh_terms: D026683:Advisory Committees / Q000706:statistics & numerical data; D000818:Animals; D002986:Clinical Trials as Topic; D004274:DNA, Recombinant / Q000235:genetics*; D000229:Dependovirus / Q000235:genetics; D018014:Gene Transfer Techniques; D015316:Genetic Therapy / Q000379:methods / Q000592:standards*; D005822:Genetic Vectors; D006801:Humans; D009316:National Institutes of Health (U.S.); D017410:Practice Guidelines as Topic; D012190:Retroviridae / Q000235:genetics; D014481:United States
chemical_list: D004274:DNA, Recombinant