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Medicine and Health Sciences

Georgetown University Law Center

Series

2014

Genetic therapy

Articles 1 - 1 of 1

Full-Text Articles in Law

Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope Jan 2014

Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope

Georgetown Law Faculty Publications and Other Works

The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. Gene transfer research continues to be subjected to multiple layers of review: the Food and Drug Administration (FDA), institutional review boards, institutional biosafety committees, and the RAC. It is within the context of overlapping …