Institutional review board : management and function / [edited by] Elizabeth A. Bankert, Bruce G. Gordon, Elisa A. Hurley, Sharon P. Shriver, Public Responsibility in Medicine & Research (PRIM&R).

Format:

Book

Contributor:

Bankert, Elizabeth A., editor.

Gordon, Bruce G., editor.

Hurley, Elisa A., editor.

Shriver, Sharon P., editor.

Public Responsibility in Medicine and Research (Association), issuing body.

Frances C. Thielbar Memorial Fund.

Standardized Title:

Institutional review board (Amdur)

Language:

English

Subjects (All):

Institutional review boards (Medicine)--Management.

Institutional review boards (Medicine).

Ethics Committees, Research--organization & administration.

Medical Subjects:

Ethics Committees, Research--organization & administration.

Physical Description:

xxvi, 1086 pages : illustrations ; 28 cm

Edition:

Third edition.

Place of Publication:

Burlington, Massachusetts : Jones & Bartlett Learning, [2021]

Summary:

"The National Institutes of Health (NIH) invests over $37 billion per year in support of research to improve human health. All research funded by NIH that involves human subjects is subject to regulatory oversight, requiring institutions to staff and manage Institutional Review Boards (IRBs). IRB members, chairs, and the many associated human subjects protections oversight professionals who support the work of the IRB must navigate complex federal regulations issued by multiple agencies. This book is the industry standard reference work for the research oversight community, providing comprehensive, understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical best-practices guidelines for effectively implementing regulatory oversight"-- Provided by publisher.

Contents:

Ethical and Historical Background

Organizing the IRB Office

Organizing the IRB Committee

Single/Central IRBs

Review of Research

Informed Consent

IRB Review of Approved Protocols

Administration, Education, and Regulatory Issues

Considerations Based on Study Population

Issues Based on Study Design or Category

Research Regulated by FDA and Other Agencies

Special Topics

Reference Material.

Notes:

Previous edition: 2006.

Includes bibliographical references and index.

Local Notes:

Acquired for the Penn Libraries with assistance from the Frances C. Thielbar Memorial Fund.

ISBN:

9781284181159

1284181154

OCLC:

1198988816