Evidence map›Paper›PMID 25406085›Full record

ArticlePloS one2014

Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.

Pornpimon Adams, Jaranit Kaewkungwal, Chanthima Limphattharacharoen, Sukanya Prakobtham, Krisana Pengsaa, Srisin Khusmith

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 14% of its field
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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Evaluating IACUCs: Previous Research and Future Directions.Journal of the American Association for Laboratory Animal Science : JAALAS · 2020
    Pooled it
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  16. A Rare Opportunity: Examining the Experience of a New Institutional Review Board.Journal of empirical research on human research ethics : JERHRE · 2019
    Article
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  20. A Case-Study of the Resources and Functioning of Two Research Ethics Committees in Western India.Journal of empirical research on human research ethics : JERHRE · 2016
    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

6 authors at 2 institutions in 1 country.

Pornpimon AdamsOffice of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Jaranit KaewkungwalDepartment of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Chanthima LimphattharacharoenOffice of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Sukanya PrakobthamOffice of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Krisana PengsaaDepartment of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Srisin KhusmithDepartment of Microbiology and Immunology, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Mahidol University · THMahidol Oxford Tropical Medicine Research Unit · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an "IRB Metrics" was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010-September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with positive outcomes for all parties involved in the conduct of human-subject research.

Indexed as

FacultyTropical MedicineUniversitiesBiomedical ResearchEfficiency, OrganizationalEthics Committees, ResearchHumansResearch PersonnelSelf-AssessmentThailand

Identifiers

PMID25406085
PMCPMC4236196
OpenAlexW2031735707

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.