Evidence map›Paper›PMID 21460582›Full record

SynthesisJournal of empirical research on human research ethics : JERHRE2011

A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn.

Lura Abbott, Christine Grady

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of empirical research on human research ethics : JERHRE, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 98 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 2 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

98 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Evaluating IACUCs: Previous Research and Future Directions.Journal of the American Association for Laboratory Animal Science : JAALAS · 2020
    Pooled it
  3. Responses to Commentaries on "Ethics as if Your Life Depended on It".Journal of empirical research on human research ethics : JERHRE · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
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  10. Review
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  13. Review
  14. Article
  15. Socially responsible science: Exploring the complexities.European journal for philosophy of science · 2023
    Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Protecting human subjects participating in research.American journal of translational research · 2023
    Article

38 more citing papers are in PubMed but not listed here.

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

2 authors.

Lura AbbottDepartment of Bioethics, National Institutes of Health, Clinical Center, Building 10/1C118, Bethesda, MD 20892, USA.
Christine Grady

Funding

Intramural NIH HHS Z99 CL999999
6 · The paper itself

Abstract

Institutional review boards (IRBs) are integral to the U.S. system of protection of human research participants. Evaluation of IRBs, although difficult, is essential. To date, no systematic review of IRB studies has been published. We conducted a systematic review of empirical studies of U.S. IRBs to determine what is known about the function of IRBs and to identify gaps in knowledge. A structured search in PubMed identified forty-three empirical studies evaluating U.S. IRBs. Studies were included if they reported an empirical investigation of the structure, process, outcomes, effectiveness, or variation of U.S. IRBs. The authors reviewed each study to extract information about study objectives, sample and methods, study results, and conclusions. Empirical evidence collected in forty-three published studies shows that for review of a wide range of types of research, U.S. IRBs differ in their application of the federal regulations, in the time they take to review studies, and in the decisions made. Existing studies show evidence of variation in multicenter review, inconsistent or ambiguous interpretation of the federal regulations, and inefficiencies in review. Despite recognition of a need to evaluate effectiveness of IRB review, no identified published study included an evaluation of IRB effectiveness. Multiple studies evaluating the structure, process, and outcome of IRB review in the United States have documented inconsistencies and inefficiencies. Efforts should be made to address these concerns. Additional research is needed to understand how IRBs accomplish their objectives, what issues they find important, what quality IRB review is, and how effective IRBs are at protecting human research participants.

Indexed as

Ethics Committees, ResearchMulticenter Studies as TopicUnited States

Identifiers

PMID21460582
PMCPMC3235475

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.