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, 1976U.S. Government Printing Office, 1977 - 160 páginas |
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activities agencies AMETA bacteria BALTIMORE believe bioassay testing biohazards biological containment Carcinogenesis Program cells Chairman chemicals coli committee concern CONGRESS THE LIBRARY containment facilities contract dangerous David Baltimore Director discuss disease drug industry Edward environment environmental experiments FCRC Federal FREDRICKSON genes genetic going Government hearings human important Institutes of Health interagency involved issue Javits knowledge LIBRARY OF CONGRESS Litton Bionetics member firms ment molecular monitoring National Cancer Institute National Institutes NIH guidelines organisms patent Paul Berg personnel plasmid potential hazards Practice and Procedure prime contractor problems protection public health question radiation safety officer recombinant DNA molecules recombinant DNA research recombinant research responsibility risks safety procedures Saffiotti science policy scientific community scientists sector Senator KENNEDY Senator SCHWEIKER Sinsheimer specific staff statement STETLER stringent Subcommittee on Health subcontractor laboratories testimony tion Tracor Tracor Jitco virus ZINDER
Passagens conhecidas
Página 124 - 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 WOULD NOT BE AVAILABLE FOR EK~1 AND EK-2 HOST VECTOR SYSTEMS. MANY OF OUR MEMBER FIRMS NOW ROUTINELY USE Pl AND P-2 PHYSICAL CONTAINMENT FACILITIES IN THEIR RESEARCH OPERATIONS AND IT IS NOT UNCOMMON TO FIND FACILITIES IN THE DRUG INDUSTRY THAT CORRESPOND VERY CLOSELY TO THE SPECIFICATIONS FOR P-3...
Página 130 - ONE HAND, AND THE NEED FOR PEER REVIEW AND COMPLIANCE WITH VOLUNTARY CONTROLS ON THE OTHER. WE BELIEVE THAT THESE TWO CONCEPTS ARE COMPATIBLE AND ARE ACCEPTED BY RESPONSIBLE SCIENTISTS AND MANAGEMENT IN THE DRUG INDUSTRY AND BY OTHER ELEMENTS OF THE SCIENTIFIC COMMUNITY. To THIS END, IT IS OUR OPINION THAT A GOOD START HAS BEEN MADE IN THE "GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES", PUBLISHED IN THE FEDERAL REGISTER ON JULY 7 BY THE NATIONAL INSTITUTES OF HEALTH.
Página 123 - Register on July 7 by the National Institutes of Health. As you may be aware, representatives of the drug industry took part in a meeting called by the Director of NIH on June 2 of this year. On that occasion, as the PMA spokesman, I said that our member firms would respond to the request for critical review of the guidelines and that immediate steps would be taken to convene a panel of experts for that purpose. That panel has since studied the question and, in addition, we have requested comments...
Página 16 - 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 manner for better or worse? I think not...
Página 20 - ... BY DR. DONALD S. FREDRICKSON, DIRECTOR NATIONAL INSTITUTES OF HEALTH ON RECOMBINANT DNA RESEARCH BEFORE THE SUBCOMMITTEE ON HEALTH SENATE COMMITTEE ON LABOR AND PUBLIC WELFARE SEPTEMBER 22, 1976 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....
Página 55 - NIH guidelines. In response, the NIH Recombinant Advisory Committee (formally "NIH Recombinant DNA Molecule Program Advisory Committee") was established in October 1974 to advise the Secretary of HEW, the Assistant Secretary for Health, and the Director of NIH to accomplish these tasks. The several meetings at which the Recombinant Advisory Committee developed its proposed guidelines in 1975 were announced in the Federal Register and were open to the public. The committee, after working several draft...
Página 57 - A meeting was held with representatives of relevant 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...
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 130 - REGISTER ON JULY 7 BY THE NATIONAL INSTITUTES OF HEALTH. AS YOU MAY BE AWARE, REPRESENTATIVES OF THE DRUG INDUSTRY TOOK PART IN A MEETING CALLED BY THE DIRECTOR OF NIH ON JUNE 2 OF THIS YEAR. ON THAT OCCASION, AS THE PMA SPOKESMAN, I SAID THAT OUR MEMBER FIRMS WOULD RESPOND TO THE REQUEST FOR CRITICAL REVIEW OF THE GUIDELINES AND THAT IMMEDIATE STEPS WOULD BE TAKEN TO CONVENE A PANEL OF EXPERTS FOR THAT PURPOSE, THAT PANEL HAS SINCE STUDIED THE QUESTION.. AND, IN ADDITION, WE HAVE REQUESTED COMMENTS...
Página 1 - 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 this matter. But it, can and should take the lead in assuring that these issues are discussed publicly, and by as broad a segment of the population as possible.