Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews
| Autor: | Daniel E. Hall, Ulrike Feske, Bruce S. Ling, Robert M. Arnold, Susan Zickmund, Ali F. Sonel, Min-Fu Tsan, Michael J. Fine, Roslyn A. Stone |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Scrutiny Social Psychology Computer science media_common.quotation_subject 0603 philosophy ethics and religion Article Education 03 medical and health sciences IRB Approval Office for Human Research Protections 0302 clinical medicine Common Rule medicine Humans Quality (business) Medical physics 030212 general & internal medicine health care economics and organizations media_common Protocol (science) Communication 06 humanities and the arts Review procedure Institutional review board humanities 060301 applied ethics Ethics Committees Research |
| Zdroj: | J Empir Res Hum Res Ethics |
| ISSN: | 1556-2654 1556-2646 |
| DOI: | 10.1177/1556264620956795 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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