Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee

Type: Consensus Study
Topics: Biomedical and Health Research, Diseases
Board: Board on Health Sciences Policy

Activity Description

Following the recommendations of scientists concerned about new research involving recombinant DNA (rDNA) technology in the 1970’s, the National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC). One of the first actions of the RAC was to develop guidelines for rDNA research conducted by NIH laboratories or by other institutions receiving NIH funding for such research.

Since its creation, the roles and responsibilities of the RAC have changed as the science evolved and as experience with RAC and other oversight accumulated. Studies involving new genetic technologies like gene transfer research, which refers to the deliberate administration of genetic material into a human patient with the intent of correcting a specific genetic defect, continue to be within the purview of the RAC.

This IOM study will evaluate if gene transfer research in general or in selected areas can still considered novel science that is worthy of the special protocol oversight undertaken by the RAC. The IOM committee's evaluation of the RAC will consider the current regulatory environment and policy context, including the roles of other entities overseeing gene transfer research as well as the scientific, safety, ethical and other concerns that would justify a special level of oversight. If the committee determines that RAC oversight is still warranted, it will recommend criteria to guide when the RAC should review this research. The committee’s evaluation should assist in informing future discussions of how and when emerging fields of investigation in the life sciences warrant special levels of oversight.

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