Future Oversight of Recombinant DNA Research: Recommendations of an Institute of Medicine Committee

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 (rDNA).1 Jesse Gelsinger’s death during a genetic therapy trial in 1999 further galvanized societal apprehensions.2 The RAC—a federal advisory committee to the NIH director—performs multiple functions: reviewing all gene transfer protocols, selecting specific protocols for public review, and acting as a national forum for rDNA research.3 Through its Gene Transfer Safety Assessment Board the RAC also surveils, aggregates, and analyzes adverse events across all human gene transfer trials.

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