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
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.
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.
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
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.
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.