New Gene Policy, Loss of RAC May Necessitate Greater Local Expertise

Now that NIH has officially disbanded (reconstituted, it says) a long-standing gene research review board that had recently become virtually inactive, institutional oversight panels will take on greater significance and their roles likely will need to be revised.

On April 26, NIH published a Federal Register notice announcing “final action” regarding research involving recombinant or synthetic nucleic acid molecules to “streamline oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within the existing regulatory framework.” The notice finalized draft changes announced in August.

Although there were other important ones, the primary change was to eliminate review by the Recombinant DNA Advisory Committee (RAC), which had been operational since 1974. NIH ceased reviews in August when the revisions were proposed.

Other changes, which went into effect with publication of the notice, redefine the role of the institutional biosafety committees (IBCs) and may place greater responsibility on institutional review boards (IRBs), according to Daniel Kavanagh, scientific lead in the Institutional Biosafety Committee of WIRB-Copernicus Group.

Along with the Food and Drug Administration, NIH introduced new guidelines that “remove the requirement to register and report on human gene therapy protocols,” referring to RAC reviews. The agency added that “[r]obust oversight continues under the FDA, which has regulatory oversight of all human gene therapy clinical trials. In addition, NIH-funded human gene therapy research remains subject to the usual NIH oversight that applies to all NIH-funded research, and oversight by local authorities,” for example, IBCs and IRBs.

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