Oversight and review of clinical gene transfer protocols : assessing the role of the Recombinant DNA Advisory Committee

Resource Information

The work Oversight and review of clinical gene transfer protocols : assessing the role of the Recombinant DNA Advisory Committee represents a distinct intellectual or artistic creation found in University of Missouri-Kansas City Libraries. This resource is a combination of several types including: Work, Language Material, Books.

Label

Oversight and review of clinical gene transfer protocols : assessing the role of the Recombinant DNA Advisory Committee

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

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

Contributor

• Altevogt, Bruce M.
• Gostin, Lawrence O., (Lawrence Ogalthorpe)
• Lenzi, Rebecca N.

Author

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

Editor

• Gostin, Lawrence O., (Lawrence Ogalthorpe)
• Lenzi, Rebecca N.
• Altevogt, Bruce M.

Subject

• Advisory Committees -- standards
• Clinical Trials as Topic -- standards
• Clinical Trials as Topic -- standards
• Electronic books
• Gene Transfer Techniques -- standards
• Gene Transfer Techniques -- standards
• Genetic Research
• Genetic Research
• 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
• Guideline
• Guideline
• Institutional review boards (Medicine) -- United States -- Evaluation
• National Institutes of Health (U.S.), Recombinant DNA Advisory Committee
• National Institutes of Health (U.S.), Recombinant DNA Advisory Committee
• Recombinant DNA -- Research | Health aspects -- United States
• Recombinant DNA -- Research | Moral and ethical aspects -- United States
• SCIENCE -- Life Sciences | Evolution
• United States
• Genetics -- Research | Moral and ethical aspects -- United States
• Advisory Committees -- standards

Genre

• Guideline
• Electronic books

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

Member of

• Ebook Central Academic Complete

Cataloging source

NLM

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.

Illustrations

illustrations

Index

no index present

LC call number

QH448.4

Literary form

non fiction

Nature of contents

• dictionaries
• bibliography
• technical reports

NLM call number

• 2014 I-979
• QU 550