Significant Changes to Institutional Review Boards Proposed: Government May Issue First Changes in Decades to the Common Rule on Human Subjects Research

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.

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The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research

Accountability in Research ◽

10.1080/08989620802201866 ◽

2008 ◽

Vol 15 (3) ◽

pp. 188-204 ◽

Cited By ~ 11

Author(s):

Jason Borenstein

Keyword(s):

Human Subjects ◽

Institutional Review Boards ◽

Human Subjects Research ◽

Institutional Review ◽

Review Boards

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Human Subjects Research: A Handbook for Institutional Review Boards

JAMA ◽

10.1001/jama.1983.03330320063042 ◽

1983 ◽

Vol 249 (8) ◽

pp. 1065

Author(s):

George J. Annas

Keyword(s):

Human Subjects ◽

Institutional Review Boards ◽

Human Subjects Research ◽

Institutional Review ◽

Review Boards

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Symposium on Human Subjects Research: Redux

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2002.tb00403.x ◽

2002 ◽

Vol 30 (3) ◽

pp. 358-360

Author(s):

Jesse A. Goldner

Keyword(s):

Quality Improvement ◽

Human Subjects ◽

Institutional Review Boards ◽

Human Subjects Research ◽

Institutional Review ◽

New Directions ◽

Short Run ◽

Research Protections ◽

Review Boards

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections (OHRP), directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member.

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Comment on the Proposed Institutional Review Board Retrospective Review of Research

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264620908153 ◽

2020 ◽

Vol 15 (3) ◽

pp. 229-231 ◽

Cited By ~ 1

Author(s):

Min-Fu Tsan

Keyword(s):

Retrospective Review ◽

Human Subjects ◽

Institutional Review Board ◽

Human Subjects Research ◽

Common Rule ◽

Institutional Review ◽

The Common

Investigators of nonexempt human subjects research conducted without prior institutional review board (IRB) approval often have difficulties in publishing data obtained from such research. Retrospective review and approval of such research has been suggested as a potential pathway for an IRB to help these investigators to publish those data. However, under the Common Rule, an IRB has no authority to retrospectively review and approve human subjects research. Prevention remains the best strategy to ensure that no nonexempt human subjects research is initiated prior to IRB approval.

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