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Oversight and Review of Clinical Gene Transfer Protocols - Assessing the Role of the Recombinant DNA Advisory Committee (Paperback)
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Oversight and Review of Clinical Gene Transfer Protocols - Assessing the Role of the Recombinant DNA Advisory Committee (Paperback)
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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.
Table of Contents Front Matter Summary 1 Introduction 2 Gene
Transfer Research: The Evolution of the Clinical Science 3
Oversight of Gene Transfer Research 4 Evolution of Oversight of
Emerging Clinical Research Appendix A: Data Sources and Methods
Appendix B: Historical and Policy Timelines for Recombinant DNA
Technology Appendix C: Committee Biographies
General
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