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Author Institute of Medicine (U.S.). Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee, author

Title 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
Published Washington, D.C. : National Academies Press, [2014]
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Description 1 online resource (1 PDF file (xviii, 116 pages : illustrations))
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
Notes Title from PDF title page
Bibliography Includes bibliographical references
Notes 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
Description based on version viewed July 9, 2014
Subject National Institutes of Health (U.S.). Recombinant DNA Advisory Committee.
Genetic transformation -- Research -- Health aspects -- United States.
Genetic transformation -- Research -- Moral and ethical aspects -- United States.
Genetics -- Research -- Health aspects -- United States.
Genetics -- Research -- Moral and ethical aspects -- United States.
Institutional review boards (Medicine) -- United States -- Evaluation.
Recombinant DNA -- Research -- Health aspects -- United States.
Recombinant DNA -- Research -- Moral and ethical aspects -- United States.
Gene Transfer Techniques -- standards.
Advisory Committees -- standards.
Clinical Trials as Topic -- standards.
Genetic Research.
Genre/Form Guideline.
Form Electronic book
Author Altevogt, Bruce M., editor
Gostin, Lawrence O. (Lawrence Ogalthorpe), editor
Lenzi, Rebecca N., editor
ISBN 0309296625
0309296633
9780309296625
9780309296632