J 
PREFACE 
On Wednesday, June 23, 1976, the National Institutes of Health 
issued guidelines to govern NIH-supported research on recombinant DNA 
molecules. These guidelines, governing research at laboratories of NIH 
and of its grantees and contractors, delineate stringent safeguards for 
the conduct of experiments involving the production of recombinant DNA 
molecules and their insertion into organisms such as bacteria. The NIH 
guidelines replaced the recommendations from the 1975 Asilomar 
Conference on Recombinant DNA Molecules, which permitted research 
under less strict conditions. 
Recombinant DNA molecules are formed in the test tube from recom- 
bination of segments of deoxyribonucleic acid, the material that 
determines the hereditary characteristics of all living cells. These 
techniques, permitting genetic information from quite different organ- 
isms to be combined, have a remarkable potential for furthering the 
understanding of fundamental biochemical processes of lower and higher 
organisms, and promise to revolutionize molecular biology. They often 
involve potential hazards, however, which dictate that the research 
proceed with considerable caution. 
Accompanying the guidelines was a document describing in detail 
the issues which I considered in reaching the decision, as Director 
of NIH, to release the guidelines developed in the light of many expert 
judgments. My decision was based on the documents and correspondence 
contained in the present report. Included is the transcript of a special 
meeting of the Director's Advisory Committee held at NIH on February 9 
and 10, 1976, for the purpose of reviewing proposed courses of action. 
The guidelines they considered were developed by an NIH Advisory 
Committee and submitted to the Director of NIH in December 
1975. 
The meeting of the Director's Advisory Committee afforded an 
opportunity for the scientific community and the public to comment on 
the proposed guidelines. Members of the committee represented not 
only science but such other disciplines as law, ethics, and consumer 
affairs. The issues raised at that hearing and in the correspondence 
addressed to me on this matter were carefully reviewed, and my decision, 
based on this record, examines each of the substantive issues presented. 
The final guidelines contain a number of revisions based on that analysis. 
This report is intended to be the first in a series that will provide 
the basis for further decisions as the guidelines evolve. On July 7, 1976, 
NIH published the guidelines in the Federal Register, inviting further 
public comment. NIH has also undertaken an environmental impact 
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