Please note: In order to keep Hive up to date and provide users with the best features, we are no longer able to fully support Internet Explorer. The site is still available to you, however some sections of the site may appear broken. We would encourage you to move to a more modern browser like Firefox, Edge or Chrome in order to experience the site fully.

Supporting your high street Find out how »
Oversight and Review of Clinical Gene Transfer Protocols : Assessing the Role of the Recombinant DNA Advisory Committee, Paperback / softback Book

Oversight and Review of Clinical Gene Transfer Protocols : Assessing the Role of the Recombinant DNA Advisory Committee Paperback / softback

Edited by Lawrence O. Gostin, Bruce M. Altevogt, Rebecca N. Lenzi

Paperback / softback

Available to Order - This title is available to order, with delivery expected within 2 weeks

Description

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 ContentsFront MatterSummary1 Introduction2 Gene Transfer Research: The Evolution of the Clinical Science3 Oversight of Gene Transfer Research4 Evolution of Oversight of Emerging Clinical ResearchAppendix A: Data Sources and MethodsAppendix B: Historical and Policy Timelines for Recombinant DNATechnologyAppendix C: Committee Biographies

Information

Other Formats

Save 4%

£37.00

£35.45

Available to Order - This title is available to order, with delivery expected within 2 weeks
Add to Basket
Sign in to add to wishlist
 
Free Home Delivery

on all orders

 
Pick up orders

from local bookshops

Information