International Analysis of Institutional Review Boards Registered with the U.S. Office for Human Research Protections

2008 ◽  
Vol 3 (4) ◽  
pp. 49-56 ◽  
Author(s):  
Edward E. Bartlett
Keyword(s):  
Institutional Review Boards ◽  
Human Research ◽  
Institutional Review ◽  
Research Protections ◽  
The U.S ◽  
Review Boards

scholarly journals Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews

2020 ◽  
Vol 15 (5) ◽  
pp. 407-414
Author(s):  
Min-Fu Tsan ◽  
Bruce Ling ◽  
Ulrike Feske ◽  
Susan Zickmund ◽  
Roslyn Stone ◽  
...  
Keyword(s):  
Human Subject ◽  
Institutional Review Boards ◽  
Human Research ◽  
Institutional Review ◽  
Review Procedure ◽  
Research Protections ◽  
And Performance ◽  
Board Review ◽  
Protocol Review ◽  
Review Boards

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

Symposium on Human Subjects Research: Redux

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.

The Institutional Review Board and Protecting Human Subjects: 10 Frequently Asked Questions

2005 ◽  
Vol 15 (3) ◽  
pp. 291-295
Author(s):  
Sheldon Zink ◽  
Laura Kimberly ◽  
Stacey Wertlieb
Keyword(s):  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Human Research ◽  
Institutional Review Board Approval ◽  
Institutional Review ◽  
Human Research Subjects ◽  
Review Boards

It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

scholarly journals Supporting the Creation of New Institutional Review Boards in Developing Countries: The U.S. Naval Medical Research Center Detachment Experience

2008 ◽  
Vol 173 (10) ◽  
pp. 975-977 ◽  
Author(s):  
A. Roxana Lescano ◽  
David L. Blazes ◽  
Silvia M. Montano ◽  
Tadeusz Kochel ◽  
Zoe Moran ◽  
...  
Keyword(s):  
Developing Countries ◽  
Medical Research ◽  
Research Center ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
The Creation ◽  
The U.S ◽  
Review Boards
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