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Oversight and review of clinical gene transfer protocols assessing the role of the Recombinant DNA Advisory Committee [electronic resource]
Lenzi, Rebecca N
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| 자료유형 | E-BOOK |
|---|---|
| 서명/저자사항 | Oversight and review of clinical gene transfer protocols [electronic resource]: 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. |
| 개인저자 | Lenzi, Rebecca N, Altevogt, Bruce M, Gostin, Lawrence O.(Lawrence Ogalthorpe), |
| 단체저자명 | Institute of Medicine (U.S.). Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee,author. |
| 발행사항 | Washington, D.C.: National Academies Press, [2014]. |
| 형태사항 | 1 online resource (1 PDF file (xviii, 116 pages): illustrations. |
| 기타형태 저록 | Print version: Oversight and review of clinical gene transfer protocols. Washington, D.C. : National Academies Press, 2014 0309296625 |
| ISBN | 9780309296632 0309296633 |
| 일반주기 |
Title from PDF title page.
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| 서지주기 | Includes bibliographical references. |
| 요약 | 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. |
| 기금정보주기 | 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. |
| 주제명(단체명) | National Institutes of Health (U.S.). --Recombinant DNA Advisory Committee. National Institutes of Health (U.S.). --Recombinant DNA Advisory Committee. |
| 일반주제명 | Gene Transfer Techniques --standards --Guideline. Advisory Committees --standards --Guideline. Clinical Trials as Topic --standards --Guideline. Genetic Research --Guideline. Institutional review boards (Medicine) --United States --Evaluation. Genetics --Research --Moral and ethical aspects --United States. Genetics --Research --Health aspects --United States. Recombinant DNA --Research --Moral and ethical aspects --United States. Recombinant DNA --Research --Health aspects --United States. Genetic transformation --Research --Moral and ethical aspects --United States. Genetic transformation --Research --Health aspects --United States. SCIENCE / Life Sciences / Evolution |
| 언어 | 영어 |
| 바로가기 | URL |
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