Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences

2014 ◽  
Keyword(s):  
Social Sciences ◽  
Human Subjects ◽  
Common Rule ◽  
The Common ◽  
Protection Of Human Subjects

Vexed Again: Social Scientists and the Revision of the Common Rule, 2011-2018

2019 ◽  
Vol 47 (2) ◽  
pp. 254-263 ◽  
Author(s):  
Zachary M. Schrag
Keyword(s):  
Human Subjects ◽  
Social Scientists ◽  
Revision Process ◽  
Common Rule ◽  
Social Sciences And Humanities ◽  
The Social ◽  
Final Rule ◽  
Advance Notice ◽  
The Common ◽  
Protection Of Human Subjects

In revising the Federal Policy for the Protection of Human Subjects (Common Rule) between 2009 and 2018, regulators devoted the vast bulk of their attention to debates over biomedical research. They lacked both expertise in and concern about the social sciences and humanities, yet they imposed their will on experts in those fields. The revision process was secretive, spasmodic, and unrepresentative, especially compared to rulemaking in Canada, where social scientists participate in the process, and revisions take place every few years. The result was a final rule that offers some wins for social science and the humanities, but that fails to solve the problems identified by Ezekiel Emanuel and in the 2011 advance notice of proposed rulemaking.

Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research

2011 ◽  
Vol 39 (3) ◽  
pp. 488-501 ◽  
Author(s):  
Ana S. Iltis
Keyword(s):  
United States ◽  
Human Subjects ◽  
United States Public Health ◽  
The United States ◽  
National Commission ◽  
Human Research ◽  
Common Rule ◽  
Department Of Health ◽  
The Common ◽  
Protection Of Human Subjects

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study.

Currents in Contemporary Ethics

2005 ◽  
Vol 33 (1) ◽  
pp. 154-159 ◽  
Author(s):  
Mark A. Rothstein
Keyword(s):  
Privacy Protection ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Common Rule ◽  
Privacy Rule ◽  
Institutional Review ◽  
The Common ◽  
Protection Of Human Subjects ◽  
Privacy Issues

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects (Common Rule). As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards (IRBs). In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research.

The Invisible Vulnerable: The Economically and Educationally Disadvantaged Subjects of Clinical Research

2003 ◽  
Vol 31 (1) ◽  
pp. 149-153 ◽  
Author(s):  
T. Howard Stone
Keyword(s):  
Human Subjects ◽  
Disabled Persons ◽  
Federal Regulations ◽  
Research Subjects ◽  
Undue Influence ◽  
Common Rule ◽  
Educationally Disadvantaged ◽  
Mentally Disabled ◽  
The Common ◽  
Protection Of Human Subjects

U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.

Biobanking Research and Privacy Laws in the United States

2016 ◽  
Vol 44 (1) ◽  
pp. 106-127 ◽  
Author(s):  
Heather L. Harrell ◽  
Mark A. Rothstein
Keyword(s):  
Human Subjects ◽  
The United States ◽  
Common Rule ◽  
State Laws ◽  
Privacy Rule ◽  
Biobank Research ◽  
Privacy Laws ◽  
The Us ◽  
Protection Of Human Subjects ◽  
Hipaa Privacy Rule

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

Learning Health Systems and the Revised Common Rule

2019 ◽  
Vol 47 (2) ◽  
pp. 238-246 ◽  
Author(s):  
Joshua A. Rolnick
Keyword(s):  
Public Policy ◽  
Quality Improvement ◽  
Health Systems ◽  
Human Subjects ◽  
Minimal Risk ◽  
Human Subjects Research ◽  
Common Rule ◽  
Quality Improvement Process ◽  
Improvement Process ◽  
The Common

Quality improvement (QI) is an important function of learning health systems, and public policy should promote QI activities. Use of systematic methodologies in QI has prompted substantial confusion regarding when QI is human subjects research under the Common Rule, and this confusion persists with the revised Rule. Difficulty distinguishing research from QI imposes costs on the quality improvement process. I offer guidance to IRBs to mitigate these costs and suggest a new regulatory exclusion for minimal risk quality improvement activities.

scholarly journals Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?

2013 ◽  
Vol 41 (2) ◽  
pp. 440-453 ◽  
Author(s):  
Brett A. Williams ◽  
Leslie E. Wolf
Keyword(s):  
Human Services ◽  
Human Subjects ◽  
Regulatory System ◽  
Research Subjects ◽  
Human Subjects Research ◽  
Common Rule ◽  
Department Of Health ◽  
Initial Interaction ◽  
Research Protections ◽  
The Common

The U.S. Department of Health and Human Services (HHS) has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking (ANPRM), entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers.

Redefining the Common Rule and Easing Investigator Burden in the Social Sciences

PsycCRITIQUES ◽  
2015 ◽  
Vol 60 (15) ◽  
Author(s):  
Richard F. Ittenbach ◽  
Jeremy J. Corsmo
Keyword(s):  
Social Sciences ◽  
Common Rule ◽  
The Social ◽  
The Common
Sign in / Sign up

Export Citation Format

Share Document