Evidence map›Paper›PMID 32917103›Full record

ArticleJournal of empirical research on human research ethics : JERHRE2020

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

Min-Fu Tsan, Bruce Ling, Ulrike Feske, Susan Zickmund, Roslyn Stone, Ali Sonel, Robert M Arnold, Michael Fine, Daniel E Hall

Abstract read
In one paragraph

Article in Journal of empirical research on human research ethics : JERHRE, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Protecting human subjects participating in research.American journal of translational research · 2023
    Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Min-Fu TsanMcGuire Research Institute, Richmond, VA, USA.ORCID 0000-0002-0142-1873
Bruce LingVA Pittsburgh Healthcare System, PA, USA.
Ulrike FeskeVA Pittsburgh Healthcare System, PA, USA.
Susan ZickmundVA Pittsburgh Healthcare System, PA, USA.
Roslyn StoneVA Pittsburgh Healthcare System, PA, USA.
Ali SonelVA Pittsburgh Healthcare System, PA, USA.
Robert M ArnoldUniversity of Pittsburgh, PA, USA.
Michael FineVA Pittsburgh Healthcare System, PA, USA.
Daniel E HallVA Pittsburgh Healthcare System, PA, USA.

Funding

HSRD VA I01 HX000839
6 · The paper itself

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.

Indexed as

Ethics Committees, ResearchHumansexempt protocolsexpedited reviewfull board reviewinstitutional review boardlevels of review

Identifiers

PMID32917103
PMCPMC8823949

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.