What are the “NIH Guidelines” and how do they guide the process of NIH oversight of human gene transfer trials?
The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) set forth the principles for NIH and institutional oversight of recombinant DNA research, including human gene transfer trials. The NIH Guidelines were first published in 1976 as an outcome of a public process by which scientists developed standards to address the risks associated with recombinant DNA research. The NIH Guidelines articulate standards for investigators and institutions to follow to ensure the safe handling and containment of recombinant DNA and products derived therefrom. They outline requirements for institutional oversight, including Institutional Biosafety Committees (IBCs), and describe the procedures of the Recombinant DNA Advisory Committee.
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