The Resource 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

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

Label
Oversight and review of clinical gene transfer protocols : assessing the role of the Recombinant DNA Advisory Committee
Title
Oversight and review of clinical gene transfer protocols
Title remainder
assessing the role of the Recombinant DNA Advisory Committee
Statement of responsibility
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
Creator
Contributor
Author
Editor
Subject
Genre
Language
eng
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
Cataloging source
DNLM
Dewey number
576.5
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
Index
no index present
LC call number
QH448.4
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Label
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
Publication
Note
Title from PDF title page
Bibliography note
Includes bibliographical references
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
black and white
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
Gene transfer research : the evolution of the clinical science -- Oversight of gene transfer research -- Evolution of oversight of emerging clinical research
Control code
ocn881654717
Dimensions
unknown
Extent
1 online resource (1 PDF file (xviii, 116 pages
Form of item
online
Isbn
9780309296632
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations))
http://library.link/vocab/recordID
.b35587635
Specific material designation
remote
System control number
  • (OCoLC)881654717
  • pebcs0309296625

Library Locations

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