ArticleBMC medical ethics2017
Measuring inconsistency in research ethics committee review.
Article in BMC medical ethics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Blood pressure categories defined by the 2017 ACC/AHA guideline and all-cause mortality: a national cohort study in China and meta-analysis.Journal of human hypertension · 2022Pooled it
- Advancing health research practices among forcibly displaced populations: A multidisciplinary stakeholder workshop.Health research policy and systems · 2026Article
- A Scoping Review of Empirical Research on Research Ethics Board Membership and Expertise.Journal of empirical research on human research ethics : JERHRE · 2025Article
- Perspectives of Artificial Intelligence Use for In-House Ethics Checks of Journal Submissions.Journal of Korean medical science · 2025Review
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- Enablers and Barriers of Research Engagement Among Clinician Researchers: Nursing, Allied Health and Medical Professionals.Journal of multidisciplinary healthcare · 2024Article
- Evidence from UK Research Ethics Committee members on what makes a good research ethics review, and what can be improved.PloS one · 2023Article
- Electronic informed consent criteria for research ethics review: a scoping review.BMC medical ethics · 2022Article
- Article
- Clarifying how to deploy the public interest criterion in consent waivers for health data and tissue research.BMC medical ethics · 2020Article
- Article
- Research approvals iceberg: helping it melt away.BMC medical ethics · 2019Article
- Participants' awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.BMC medical ethics · 2019Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called "Shared Ethical Debate" (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes.
methodsWe present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published "mystery shopper" exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise.
resultsOur analysis highlights qualitative differences between the ShED 19, ShED 20 and "mystery shopper" exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises.
conclusionsShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be.
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Registered trials
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.