Coverart for item
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, (electronic 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, (electronic resource)

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
Subject
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
  • 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
  • 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
  • Annotation:
Cataloging source
DNLM
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.
NLM call number
  • 2014 I-979
  • QU 550
http://bibfra.me/vocab/lite/organizationName
Institute of Medicine (U.S.)
http://library.link/vocab/relatedWorkOrContributorName
  • Lenzi, Rebecca N
  • Altevogt, Bruce M
  • Gostin, Lawrence O.
http://library.link/vocab/subjectName
  • National Institutes of Health (U.S.)
  • Gene Transfer Techniques
  • Genetic Research
  • Advisory Committees
  • Clinical Trials as Topic
Summary expansion
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
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, (electronic resource)
Instantiates
Publication
Note
Title from PDF title page
Bibliography note
Includes bibliographical references
Contents
Gene transfer research : the evolution of the clinical science -- Oversight of gene transfer research -- Evolution of oversight of emerging clinical research
Control code
OCM1bookssj0001219050
Dimensions
unknown
Isbn
9780309296625
Note
Electronic reproduction. Palo Alto, Calif. : ebrary, 2014. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.
Specific material designation
remote
System control number
(WaSeSS)bookssj0001219050
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, (electronic resource)
Publication
Note
Title from PDF title page
Bibliography note
Includes bibliographical references
Contents
Gene transfer research : the evolution of the clinical science -- Oversight of gene transfer research -- Evolution of oversight of emerging clinical research
Control code
OCM1bookssj0001219050
Dimensions
unknown
Isbn
9780309296625
Note
Electronic reproduction. Palo Alto, Calif. : ebrary, 2014. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.
Specific material designation
remote
System control number
(WaSeSS)bookssj0001219050

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