ArticleBMJ open2016
Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.
Article in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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.
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.
Who cites it
9 citing papers in PubMed.
- Decision Letters from a Kyrgyz Research Ethics Committee (2018-2022): An Empirical Review of Transparency, Rigor, and Communication.Journal of empirical research on human research ethics : JERHRE · 2026Article
- Ethics review or compliance check? an empirical analysis of 6740 requests for information in Belgian clinical trial evaluations (2017-2024).BMC medical ethics · 2025Article
- Fitting a square peg in a round hole? A mixed-methods study on research ethics and collaborative health and social care research involving 'vulnerable' groups.Health research policy and systems · 2025Article
- Towards a common European ethical and legal framework for conducting clinical research: the GATEKEEPER experience.NPJ digital medicine · 2024Article
- Ethics committees for clinical experimentation at international level with a focus on Italy.Acta bio-medica : Atenei Parmensis · 2020Review
- Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.BMC medical ethics · 2019Article
- Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013-2016): a descriptive analysis of the start-up of a new research ethics committee (REC).BMC medical ethics · 2018Article
- Effects of Regulatory Support Services on Institutional Review Board Turnaround Times.Journal of empirical research on human research ethics : JERHRE · 2017Article
- The high costs of getting ethical and site-specific approvals for multi-centre research.Research integrity and peer review · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
objectiveFrustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views.
designMixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis.
participants6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants.
resultsRates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. LIMITATIONS: This study was a non-randomised comparison cohort study. Some data were missing.
conclusionsAn ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision.
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