ABSTRACT

The National Institutes of Health (NIH) responded by developing its Guidelines for Research Involving Recombinant deoxyribonucleic acid (DNA) Molecules. The original NIH guidelines were directed to laboratory research utilizing the recombinant DNA technique, since the earliest applications were laboratory experiments to address and elucidate basic questions in biology. Investigators receiving funds from other sources, including other federal agencies, were not obligated to adhere to the NIH guidelines. The original version of the NIH guidelines issued in 1976 specified that experiments involving "deliberate release into the environment of any organism containing a recombinant DNA molecule" were "not to be initiated at the present time." The guidelines in force at the time the proposal was constructed required Recombinant DNA Advisory Committee review and NIH approval, as well as the approval of the local institutional biosafety committees for the "deliberate release into the environment of organism containing recombinant DNA."