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Author: Organisation for Economic Co-operation and Development. Ad Hoc Group on Safety and Regulations in Biotechnology Publisher: Organisation for Economic Co-operation and Development ; Washington, D.C. : OECD Publications and Information Centre ISBN: Category : Science Languages : en Pages : 80
Author: Organisation for Economic Co-operation and Development. Ad Hoc Group on Safety and Regulations in Biotechnology Publisher: Organisation for Economic Co-operation and Development ; Washington, D.C. : OECD Publications and Information Centre ISBN: Category : Science Languages : en Pages : 80
Author: Organisation for Economic Co-operation and Development. Committee for Scientific and Technological Policy Publisher: ISBN: Category : Languages : en Pages : 69
Author: Federal Interagency Committee on Recombinant DNA Research. Subcommittee on International Issues Publisher: ISBN: Category : DNA. Languages : en Pages : 140
Author: Institute of Medicine Publisher: National Academies Press ISBN: 030929665X Category : Medical Languages : en Pages : 78
Book Description
Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.
Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology Publisher: ISBN: Category : DNA. Languages : en Pages : 88
Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology Publisher: ISBN: Category : DNA. Languages : en Pages : 680
Author: Organisation for Economic Co-operation and Development. Ad Hoc Group on Safety and Regulations in Biotechnology
Author: Organisation for Economic Co-operation and Development. Ad Hoc Group on Safety and Regulations in Biotechnology
Author: Organisation for Economic Co-operation and Development. Committee for Scientific and Technological Policy
Author: Organización de Cooperación y Desarrollo Económico
Author: Economic and Social Committee of the European Communities
Author: Federal Interagency Committee on Recombinant DNA Research. Subcommittee on International Issues
Author: Institute of Medicine
Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology
Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology
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