Invited Peer Commentary: Min-Fu Tsan: Improving the Quality and Performance of Institutional Review Boards in the U.S. Through Performance Measurements

2021 ◽  
pp. 155626462110437
Author(s):  
Ryan Spellecy
Keyword(s):  
Institutional Review Boards ◽  
Performance Measurements ◽  
Institutional Review ◽  
And Performance ◽  
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.

Improving the Quality and Performance of Institutional Review Boards in the U.S.A. Through Performance Measurements

2021 ◽  
pp. 155626462110186
Author(s):  
Min-Fu Tsan
Keyword(s):  
Quality Improvement ◽  
Performance Measurement ◽  
Measurement Data ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Performance Measurements ◽  
The Past ◽  
Institutional Review ◽  
And Performance

Performance measurement leads to quality improvement, because performance measurement can identify areas of vulnerability to guide quality improvement activities. Recommendations from empirical institutional review board (IRB) performance measurement data on research approval criteria, expedited review protocols, exempt protocols, and IRB continuing review requirements published over the past 10 years are reviewed here to improve the quality and efficiency of IRBs. Implementation of these recommendations should result in improvements that can be evaluated by follow-up performance measurements.

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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