Oversight and review of clinical gene transfer protocols : assessing the role of the recombinant DNA advisory committee / Rebecca N. Lenzi, Bruce M. Altevogt, Lawrence O. Gostin, editors ; Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee : Board on Health Sciences Policy.

Format:

Book

Author/Creator:

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

Contributor:

Lenzi, Rebecca N., editor.

Altevogt, Bruce M., editor.

Gostin, Lawrence O. (Lawrence Ogalthorpe), editor.

Institute of Medicine (U.S.)

Language:

English

Subjects (All):

National Institutes of Health (U.S.). Recombinant DNA Advisory Committee.

National Institutes of Health (U.S.).

Genetics--Research--Moral and ethical aspects--United States.

Genetics.

Genetics--Research--Health aspects--United States.

Physical Description:

1 online resource (134 p.)

Edition:

1st ed.

Place of Publication:

Washington, District of Columbia : National Academies Press, 2014.

Language Note:

English

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.

Contents:

""Front Matter""; ""Reviewers""; ""Preface""; ""Contents""; ""Boxes, Figure, and Tables""; ""Acronyms and Abbreviations""; ""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""

Notes:

Description based upon print version of record.

Description based on online resource; title from PDF title page (ebrary, viewed May 5, 2014).

ISBN:

9780309296656

030929665X

9780309296632

0309296633

OCLC:

932320630