Panel approves gene trial for "normals"
Marshall, E.
Science 275(5306): 1561
1997
ISSN/ISBN: 0036-8075 PMID: 9072819 Document Number: 475533
The Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health has approved a gene trial for healthy people. Before making its decision, the RAC scrutinized the safety and scientific justification of the proposal by Ron Crystal of New York Hospital-Cornell Medical Center to study how the immune systems of healthy people would respond to engineered genes. In order to test an adenovirus vector used in cystic-fibrosis therapy, Crystal proposed injecting a version of the vector carrying an active bacterial gene into the skin of between 20 and 25 healthy adults. The decision was RAC's final act as safety enforcer, and it indicated how it might handle the new role that NIH director Harold Varmus envisioned for the committee--as a forum for debates on ethical issues.