Protect NIH's DNA Advisory Committee

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The Recombinant DNA Advisory Committee (RAC) was founded at the behest of concerned scientists based on the principle that public trust of advanced technologies must be earned through transparency and expert deliberation. For more than 40 years, the RAC has served as custodian of the National Institutes of Health (NIH) guidelines, with responsibilities in human gene therapy evolving from regulatory to advisory to the NIH and Food and Drug Administration (FDA). However, the NIH director and FDA commissioner have proposed the elimination of RAC review of human gene therapy protocols.

The changes proposed to the NIH guidelines are even broader: “Eliminat[e] references to the RAC, including its roles in [human gene therapy] and biosafety”. The NIH and FDA cited a lack of recent RAC reviews (three in 2 years) as justification for the changes. Yet, since the NIH accepted the Institute of Medicine's recommendations to restrict the RAC's advisory role, NIH itself, not the RAC, is responsible for setting the RAC's agenda. Removing RAC involvement from all aspects of human gene therapy and laboratory biosafety continues a worrisome trend of cutting independent experts and public discussion out of government decision-making.

ClinicalTrials.gov has been proposed as an alternative to the RAC. However, this system does not extend to laboratory research, provides insufficient information about ongoing human gene therapy trials to satisfy the public's interest in transparency, and—unlike the RAC—involves no scientific oversight. Current regulations require only that clinical trial results be posted within 1 year of trial completion , and in practice, this information is rarely posted.



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