Evidence map›Paper›PMID 27565086›Full record

ArticleThe Journal of surgical research2016

Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards.

Patrick R Varley, Ulrike Feske, Shasha Gao, Roslyn A Stone, Sijian Zhang, Robert Monte, Robert M Arnold, Daniel E Hall

Abstract read
In one paragraph

Article in The Journal of surgical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Evaluating IACUCs: Previous Research and Future Directions.Journal of the American Association for Laboratory Animal Science : JAALAS · 2020
    Pooled it
  2. Ethics Committees: Structure, Roles, and Issues.Journal of Korean medical science · 2023
    Review
  3. Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.Journal of empirical research on human research ethics : JERHRE · 2020
    Article
  4. Review
  5. The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time.Journal of empirical research on human research ethics : JERHRE · 2018
    Article
  6. The IRB structure and medical research reform.Clinical and translational medicine · 2018
    Article
  7. Article
  8. Effects of Regulatory Support Services on Institutional Review Board Turnaround Times.Journal of empirical research on human research ethics : JERHRE · 2017
    Article
  9. Article
  10. 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

8 authors.

Patrick R VarleyDepartment of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
Ulrike FeskeCenter for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.
Shasha GaoCenter for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.
Roslyn A StoneCenter for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.
Sijian ZhangCenter for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.
Robert MonteVeterans Engineering Resource Center, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.
Robert M ArnoldDepartment of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
Daniel E HallDepartment of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania; Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania. Electronic address: hallde@upmc.edu.

Funding

HSRD VA CDA 08-281HSRD VA SDR 11-399
6 · The paper itself

Abstract

backgroundDespite perceptions that institutional review boards (IRBs) delay research, little is known about how long it takes to secure IRB approval. We retrospectively quantified IRB review times at 10 large Veterans Affairs (VA) IRBs.

methodsWe collected IRB records pertaining to a stratified random sample of research protocols drawn from 10 of the 26 largest VA IRBs. Two independent analysts abstracted dates from the IRB records, from which we calculated overall and incremental review times. We used multivariable linear regression to assess variation in total and incremental review times by IRB and review level (i.e., exempt, expedited, or full board) and to identify potential targets for efforts to improve the efficiency and uniformity of the IRB review process.

resultsIn a sample of 277 protocols, the mean review time was 112 d (95% confidence interval [CI]: 105-120). Compared with full-board reviews at IRB 1, average review times at IRBs 3, 8, 9, and 10 were 27 (95% CI: 6-48), 37 (95% CI: 11-63), 45 (95% CI: 20-69), and 24 (95% CI: 2-45) d shorter, and at IRB 6, times were 56 (95% CI: 28-84) d longer. Across all IRBs, expedited reviews were 44 (95% CI: 30-58) d shorter on average than were full-board reviews, with no significant difference between exempt and full-board reviews. However, after subtracting the time required for Research and Development Committee review, exempt reviews were 21 (95% CI: 1-41) d shorter on average than were full-board reviews.

conclusionsIRB review times differ significantly by IRB and review level. Few VA IRBs approach a consensus panel goal of 60 d for IRB review. The unexpectedly longer review times for exempt protocols in the VA can be attributed to time required for Research and Development Committee review. Prospective, routine collection of key time points in the IRB review process could inform IRB-specific initiatives for reducing VA IRB review times.

Indexed as

Ethics Committees, ResearchTime FactorsUnited StatesUnited States Department of Veterans AffairsEfficiencyEthics committeeQuality improvement

Identifiers

PMID27565086
PMCPMC7224356

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.