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The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety.
Adv Exp Med Biol. 2015; 871:31-47.AE

Abstract

The National Institutes of Health (NIH) oversight of human gene transfer research, which is defined as the deliberate transfer of recombinant and/or synthetic nucleic acid molecules to humans, originates with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Guidelines, which were first published in the Federal Register almost 40 years ago, have been amended numerous times to remain responsive to scientific progress and to clearly define the responsibilities of NIH, the Recombinant DNA Advisory Committee (RAC), investigators, and institutions. Human gene transfer trials conducted at clinical sites in the United States (USA) are subject to the NIH Guidelines if they are conducted at, or sponsored by, an institution that receives any support for recombinant or synthetic nucleic acid research from the NIH. Human gene transfer trials conducted either in the USA or abroad are also subject to the NIH Guidelines if the investigational agent was developed with NIH funds and the institution that developed the investigational materials sponsors or participates in these projects. Trials are registered with the NIH Office Biotechnology Activities (OBA) and there are ongoing reporting requirements. Each new trial is reviewed by the RAC, and those that are novel or raise unique ethical or social issues are selected for review at quarterly public RAC meetings. The RAC also advises the NIH on policy and other matters relating to clinical gene transfer research and biosafety.

Authors+Show Affiliations

Program on Biosecurity and Biosafety Policy, Office of Science Policy, National Institutes of Health, Bethesda, MD, USA.Office of Biotechnology Activities, Office of Science Policy, Office of the Director, National Institutes of Health, Bethesda, MD, USA.Office of Biotechnology Activities, Office of Science Policy, Office of the Director, National Institutes of Health, Bethesda, MD, USA.Office of Biotechnology Activities, Office of Science Policy, Office of the Director, National Institutes of Health, Bethesda, MD, USA.Office of Biotechnology Activities, Office of Science Policy, Office of the Director, National Institutes of Health, Bethesda, MD, USA.Office of Biotechnology Activities, Office of Science Policy, Office of the Director, National Institutes of Health, Bethesda, MD, USA.Office of Biotechnology Activities, Office of Science Policy, Office of the Director, National Institutes of Health, Bethesda, MD, USA. corrigaja@nhlbi.nih.gov.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26374211

Citation

O'Reilly, Marina, et al. "The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety." Advances in Experimental Medicine and Biology, vol. 871, 2015, pp. 31-47.
O'Reilly M, Jambou R, Rosenthal E, et al. The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety. Adv Exp Med Biol. 2015;871:31-47.
O'Reilly, M., Jambou, R., Rosenthal, E., Montgomery, M., Hassani, M., Gargiulo, L., & Corrigan-Curay, J. (2015). The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety. Advances in Experimental Medicine and Biology, 871, 31-47. https://doi.org/10.1007/978-3-319-18618-4_2
O'Reilly M, et al. The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety. Adv Exp Med Biol. 2015;871:31-47. PubMed PMID: 26374211.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety. AU - O'Reilly,Marina, AU - Jambou,Robert, AU - Rosenthal,Eugene, AU - Montgomery,Maureen, AU - Hassani,Morad, AU - Gargiulo,Linda, AU - Corrigan-Curay,Jacqueline, PY - 2015/9/17/entrez PY - 2015/9/17/pubmed PY - 2015/12/30/medline KW - Adverse event database KW - Clinical trials KW - Delivery system KW - GeMCRIS KW - Human gene transfer KW - Informed consent KW - Institute of Medicine KW - NIH Guidelines KW - National Institutes of Health KW - Office of Biotechnology Activities KW - Office of Science Policy KW - Recombinant DNA Advisory Committee KW - Safety data KW - Scientific review SP - 31 EP - 47 JF - Advances in experimental medicine and biology JO - Adv. Exp. Med. Biol. VL - 871 N2 - The National Institutes of Health (NIH) oversight of human gene transfer research, which is defined as the deliberate transfer of recombinant and/or synthetic nucleic acid molecules to humans, originates with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Guidelines, which were first published in the Federal Register almost 40 years ago, have been amended numerous times to remain responsive to scientific progress and to clearly define the responsibilities of NIH, the Recombinant DNA Advisory Committee (RAC), investigators, and institutions. Human gene transfer trials conducted at clinical sites in the United States (USA) are subject to the NIH Guidelines if they are conducted at, or sponsored by, an institution that receives any support for recombinant or synthetic nucleic acid research from the NIH. Human gene transfer trials conducted either in the USA or abroad are also subject to the NIH Guidelines if the investigational agent was developed with NIH funds and the institution that developed the investigational materials sponsors or participates in these projects. Trials are registered with the NIH Office Biotechnology Activities (OBA) and there are ongoing reporting requirements. Each new trial is reviewed by the RAC, and those that are novel or raise unique ethical or social issues are selected for review at quarterly public RAC meetings. The RAC also advises the NIH on policy and other matters relating to clinical gene transfer research and biosafety. SN - 0065-2598 UR - https://www.unboundmedicine.com/medline/citation/26374211/The_National_Institutes_of_Health_Oversight_of_Human_Gene_Transfer_Research:_Enhancing_Science_and_Safety_ L2 - https://dx.doi.org/10.1007/978-3-319-18618-4_2 DB - PRIME DP - Unbound Medicine ER -