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Oversight and review of clinical gene transfer protocols : assessing the role of the Recombinant DNA Advisory Committee / Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee ; Board on Health Sciences Policy ; Rebecca N. Lenzi, Bruce M. Altevogt, Lawrence O. Gostin, editors ; Institute of Medicine of the National Academies

Corporate Author
Institute of Medicine (U.S.). Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee
Published
Washington, D.C. : National Academies Press, [2014]
Physical Description
1 online resource (1 PDF file (xviii, 116 pages : illustrations
Additional Creators
Lenzi, Rebecca N., Altevogt, Bruce M., and Gostin, Lawrence O. (Lawrence Ogalthorpe)
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Contents
Gene transfer research : the evolution of the clinical science -- Oversight of gene transfer research -- Evolution of oversight of emerging clinical research.
Summary
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.
Subject(s)
ISBN
9780309296625
0309296625
9780309296632
0309296633
Note
Title from PDF title page.
Bibliography Note
Includes bibliographical references.
Funding Information
This project was supported by Contract/Grant No. HHSN263201200074I between the National Academy of Sciences and the National Institutes of Health. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project.
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