자료유형  

 단행본

Control Number  

n881654717

International Standard Book Number  

9780309296632 electronic bk.

International Standard Book Number  

0309296633 electronic bk.

International Standard Book Number  

9780309296625

International Standard Book Number  

0309296625

Library of Congress Call Number  

QH448.4

Dewey Decimal Classification Number  

576.5-23

Main Entry-Corporate Name  

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

Physical Description  

1 online resource (1 PDF file (xviii, 116 pages : illustrations))

General Note  

Title from PDF title page.

Bibliography, Etc. Note  

Includes bibliographical references.

Summary, Etc.  

요약Gene 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.

Funding Information Note  

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.

Subject Added Entry-Corporate Name  

National Institutes of Health (U.S.). Recombinant DNA Advisory Committee

Subject Added Entry-Topical Term  

Gene Transfer Techniques standards Guideline

Subject Added Entry-Topical Term  

Advisory Committees standards Guideline

Subject Added Entry-Topical Term  

Clinical Trials as Topic standards Guideline

Subject Added Entry-Topical Term  

Genetic Research Guideline

Subject Added Entry-Corporate Name  

National Institutes of Health (U.S.). Recombinant DNA Advisory Committee

Subject Added Entry-Topical Term  

Institutional review boards (Medicine) United States Evaluation

Subject Added Entry-Topical Term  

Genetics Research Moral and ethical aspects United States

Subject Added Entry-Topical Term  

Genetics Research Health aspects United States

Subject Added Entry-Topical Term  

Recombinant DNA Research Moral and ethical aspects United States

Subject Added Entry-Topical Term  

Recombinant DNA Research Health aspects United States

Subject Added Entry-Topical Term  

Genetic transformation Research Moral and ethical aspects United States

Subject Added Entry-Topical Term  

Genetic transformation Research Health aspects United States

Subject Added Entry-Topical Term  

SCIENCE / Life Sciences / Evolution

Added Entry-Personal Name  

Lenzi, Rebecca N.

Added Entry-Personal Name  

Altevogt, Bruce M.

Added Entry-Personal Name  

Gostin, Lawrence O.((Lawrence Ogalthorpe))

Additional Physical Form Entry  

Print version Oversight and review of clinical gene transfer protocols. Washington, D.C. : National Academies Press, 2014 0309296625 (OCoLC)875999370

Electronic Location and Access  

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Control Number  

joongbu:441687