Federal Protection for Human Research Subjects : An Analysis of the Common Rule and Its Interactions with FDA Regulations and the HIPAA Privacy Rule.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Accidents--Prevention.

Accidents.

Administrative agencies.

Developing countries.

Physical Description:

1 online resource (80 pages, digital, PDF file)

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2005.

System Details:

text file

Summary:

Examines issues with the Common Rule that governs research conducted on human beings funded by Federal agencies. Provides brief overview and history of Common Rule and its regulation, and examines issues, recommendations, and proposed legislation related to scope of the Common Rule, including extending to non-federally funded research, trials in developing countries, and research involving human tissues and cells, inclusion and protection of specific vulnerable population groups, institutional review boards, mistakes and misconduct, research-related injuries, and the future of human research subjects protections. Also examines interaction of Common Rule with FDA regulations and Health Insurance Portability and Accountability Act of 1996.

Notes:

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Dec. 2010). Reuse except for individual research requires license from ProQuest, LLC.

CRS Report.

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. Federal Protection for Human Research Subjects

Access Restriction:

Restricted for use by site license.