Recombinant DNA Advisory Committee


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Recombinant DNA Advisory Committee

 [re-kom´bĭ-nant]
RAC, a committee composed of scientists and ethicists, set up to review human gene therapy research in order to protect patients from unethical practices, procedures, and research. All research involving human gene therapy must comply with both the Common Federal Rule and the RAC.
Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. © 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved.
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(4.) Department of Health and Human Services, National Institutes of Health Recombinant DNA Advisory Committee, minutes of meeting at Bethesda, Maryland, 11-12 March 1999; available at www4.od.nih.gov/oba/rac/minutes/3-99RAC.htm; C.S.
The National Institutes of Health (NIH) and its Recombinant DNA Advisory Committee (RAC), which are part of the Department of Health and Human Services, provide public oversight to gene therapy research.
These recognitions led first to a pause in the research and second to the development of various regulations and committees to oversee and regulate the research.(4) The main federal committee, the Recombinant DNA Advisory Committee, is still in existence and has been instrumental in shaping the direction of gene therapy.
In June, the National Institutes of Health Recombinant DNA Advisory Committee gave Lotze permission to pursue IL12 gene therapy.
To address the public's concerns about gene therapy and to provide guidance to gene therapy researchers, the human gene therapy subcommittee of NIH's Recombinant DNA Advisory Committee (RAC) devised a set of guidelines.
Not so for a few select groups of researchers in the field of gene therapy whose protocols were recently approved by the National Institutes of Health's Recombinant DNA Advisory Committee. These groups all use in vivo--"in the body"--to describe their novel strategies for treating cystic fibrosis (CF).
Speaking at a hearing of the National Institute of Health's (NIH) Recombinant DNA Advisory Committee (RAC), Kathryn Zoon, PhD, director of the FDA's Center for Biologics Evaluation and Research, said 17-year-old Jesse Gelsinger's elevated blood ammonia levels were indicative of liver failure, thus disqualifying him from participating in the University of Pennsylvania gene therapy experiments.
The NIH Recombinant DNA Advisory Committee (RAC) also approved second anti-AidS protocol, bringing to six the number of preliminary genetherapy trials against AIDS it has reviewed (SN: 6/12/93, p.372).
Two of 13 gene therapy protocols approved by the NIH Recombinant DNA Advisory Committee target HIV infection.
Wilson and his colleagues received approval last year from the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) to administer liver cells containing added LDL receptor genes to three patients with familial hypercholesterolemia (SN: 10/12/91, p.230).
The National Institutes of Health's Recombinant DNA Advisory Committee (RAC) voted to allow each team to squirt solutions of genetically engineered cold viruses into the nasal passages and lungs of patients.
Roth and his colleagues received approval from the NIH Recombinant DNA Advisory Committee to use the new gene-therapy procedure to treat 14 patients with advanced lung cancer.

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