Related Experiment Video
Updated: Dec 9, 2025

Qualitative and Quantitative Validation of Tools with Rating Scales Aimed at Assessing the Quality of University Service-Learning
Published on: August 29, 2025
Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews
Min-Fu Tsan1, Bruce Ling2,3,4, Ulrike Feske2
1McGuire Research Institute, Richmond, VA, USA.
Abstract:
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.
Related Concept Videos
Ethics in Research
Quality Assurance
Types of Records II: Educational and Administrative Records
SBAR II: Application of SBAR
SBAR Report from a Nurse to a Health Care Provider
S: "Hello, Dr. Smith. This is Jane, RN, from the Med Surg unit. I am calling to tell you about Ms. White in Room 210, who is experiencing increased pain and redness at her incision site. Her recent...
Purpose of Health Records I
Here's a breakdown of how health records serve these purposes:
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...

