Oversight Hearing on Implementation of NIH Guidelines Governing Recombinant DNA Research: Joint Hearing Before the Subcommittee on Health of the Committee on Labor and Public Welfare and the Subcommittee on Administrative Practice and Procedure of the Committee on the Judiciary, United States Senate, Ninety-fourth Congress, Second Session ... September 22, 1976

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Página 69 - This concludes my prepared remarks, and I will be happy to answer any questions you might have.
Página 20 - ... It is a pleasure to appear before you today to discuss the NIH guidelines on recombinant DNA research. In June, the National Institutes of Health, with the approval of the Secretary of HEW and the Assistant Secretary for Health, issued guidelines to govern NIH-supported research on recombinant DNA molecules. Accompanying the guidelines was a document describing in detail the issues which the Director of NIH considered in reaching the decision to release the guidelines. These guidelines, governing...
Página 16 - He also has pointed out that scientists have ignored "the potential broader social or ethical implications of initiating this line of research — of its. role as a possible prelude to longer range, broader scale genetic engineering of the fauna and flora of the planet, including, ultimately, man " In a philosophic sense Sinsheimer has said, "Would we wish to claim the right- of individual scientists to be free to create novel selfperpetuating organisms likely to spread about the planet in an uncontrollable...
Página 59 - Sciences created a committee that organized an international conference at Asilomar Conference Center in California, held February 1975. The committee also called on the NIH to establish an advisory committee to draft guidelines for the conduct of this research. At Asilomar, temporary guidelines were issued pending issuance of NIH guidelines. In response, the NIH Recombinant Advisory Committee (formally "NIH Recombinant DNA Molecule Program Advisory Committee") was established in October 1974 to...
Página 61 - HEW agencies and other departments of the Federal Government on April 8. The purpose was to exchange information on recombinant DNA research and to discuss the applicability of NIH guidelines to research or regulatory activities of other departments and agencies. A meeting was also held on June 2 with representatives of private industry to provide them with full information about the guidelines and to help determine the present and future interest of industrial laboratories in this type of research....
Página 20 - With your permission, I would like to submit my complete statement for the record and highlight the points I believe will be of particular interest to the subcommittee.
Página 139 - PROVISIONS OF THE NIH GUIDELINES MILITATE AGAINST RESEARCH AND DEVELOPMENT THAT WOULD POSE SUCH A THREAT TO SOCIETY. IN THE CASE OF THE DRUG INDUSTRY, IT IS HIGHLY UNLIKELY THAT RESEARCH AND DEVELOPMENT WOULD INVOLVE ORGANISMS IN CLASSES 3, 4 AND 5 AS ESTABLISHED BY THE OFFICE OF BlOSAFETY OF THE CENTER FOR DISEASE CONTROL OF THE US PUBLIC HEALTH SERVICE IN ITS PUBLICATION ENTITLED "CLASSIFICATION OF ETIOLOGIC AGENTS ON THE BASIS OF HAZARD...
Página 128 - ... provisions of the NIH guidelines militate against research and development that would pose such a threat to society. In the case of the drug industry, it is highly unlikely that research and development would involve organisms in classes 3, 4, and 5, as established by the Office of Biosaf ety of the Center for Disease Control of the US Public Health Service in its publication entitled "Classification of Etiologic Agents on the Basis of Hazard," or that adequate biological containment procedures...
Página 1 - As long as the development of technology outstrips man's capacity to understand the implications of that technology, the chances for serious errors in judgment are increased and the possibility for serious societal disruption is very real. Thus, I believe the debate over genetic engineering must go on. Scientists must tell us what they are capable of doing, but we as members of society must decide how it should be or whether it should be applied. Congress cannot legislate an appropriate answer in...
Página 6 - NIH guidelines arc necessary to protect the public in Federally funded research, it is clear they are necessary for privately funded research and application as well. The President Page Three Given the high potential risks of this research, it seems imperative that every possible measure be explored for assuring that the NIH guidelines are adhered to in all sectors of the research community. We urge you to implement these guidelines immediately wherever possible by executive directive and/or rulemaking,...

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