Crs Report for Congress Received through the Crs Web Federal Protection for Human Research Subjects

By Williams, Erin D.

Book Id: WPLBN0000020001
Format Type: PDF eBook
File Size: 0.4 MB
Reproduction Date: 2008

Title:	Crs Report for Congress Received through the Crs Web Federal Protection for Human Research Subjects
Author:	Williams, Erin D.
Volume:
Language:	English
Subject:	Government publications, Legislation., Government Printing Office (U.S.)
Collections:	Government Library Collection
Historic Publication Date:
Publisher:	Government Printing Office


Citation APA MLA Chicago Williams, E. D. (n.d.). Crs Report for Congress Received through the Crs Web Federal Protection for Human Research Subjects. Retrieved from http://www.gutenberg.us/

Excerpt
Summary: The Common Rule (45 CFR 46, Subpart A) governs research that is conducted on human beings if it is funded by one of 18 federal agencies. It requires a review of proposed research by an Institutional Review Board (IRB), the informed consent of research subjects, and institutional assurances of compliance with the regulations. In 1974, 45 CFR 46 was published following some cases of harm to human subjects, such as those caused by thalidomide drug trials and the United States Public Health Service syphilis study in Tuskeegee, Alabama. The regulations had their roots in numerous international agreements, such as the Nuremberg Code and the Declaration of Helsinki, and domestic policies, such as those put forth by the Department of Health, Education and Welfare (DHEW; now the Department of Health and Human Services, HHS). In 1991, 16 federal agencies adopted 45 CFR 46, Subpart A, which then became known as the Common Rule...

Table of Contents
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Assurance of Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 The Common Rule and 45 CFR 46 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Other Federal Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Concerns About the Common Rule . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Proposed Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Report Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 History of the Common Rule and Current Regulations . . . . . . . . . . . . . . . . . . . . 12 Issues, Recommendations, and Proposed Legislation . . . . . . . . . . . . . . . . . . . . . 16 Scope of the Common Rule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Non-Federally Funded Research and Federally Funded Research Outside the Scope of the Common Rule . . . . . . . . . . . . . . . . . . . 18 Clinical Trials in Developing Nations . . . . . . . . . . . . . . . . . . . . . . . . . 19 Human Biological Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Social and Behavioral Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Proposed Legislation affecting the Scope of the Common Rule . . . . . 24 Inclusion and Protection of Vulnerable Populations . . . . . . . . . . . . . . . . . . 25 Minorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Children who are Wards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Prisoners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Pregnant Women, Human Fetuses, and Neonates . . . . . . . . . . . . . . . . 32 Diminished Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Proposed Legislation Affecting the Inclusion and Protection of Vulnerable Populations in Research . . . . . . . . . . . . . . . . . . . . . . 34 Institutional Review Boards (IRBs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 IRB Membership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 IRB Duties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 IRB Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Defining and Weighing Risks and Potential Benefits . . . . . . . . . . . . . 37 IRB Shopping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Proposed Legislation Affecting IRBs . . . . . . . . . . . . . . . . . . . . . . . . . 42 Mistakes and Misconduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Conflicts of Interest Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Accreditation of IRBs, Researchers and Institutions . . . . . . . . . . . . . . 45 Adverse Event Reporting and Multisite Research . . . . . . . . . . . . . . . . 48 Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Monitoring of Ongoing Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Proposed Legislation Affecting the Prevention of Mistakes and Misconduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53