ArticleResearch integrity and peer review2016
The high costs of getting ethical and site-specific approvals for multi-centre research.
Article in Research integrity and peer review, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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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
12 citing papers in PubMed.
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- Monitoring performance and improving outcomes: characteristics and outputs of Australian clinical registries.Health information management : journal of the Health Information Management Association of Australia · 2026Article
- Enriching Data Science and Health Care Education: Application and Impact of Synthetic Data Sets Through the Health Gym Project.JMIR medical education · 2024Article
- Neuro-Urology and Biobanking: An Integrated Approach for Advancing Research and Improving Patient Care.International journal of molecular sciences · 2023Review
- Aortic Stenosis: Haemodynamic Benchmark and Metric Reliability Study.Journal of cardiovascular translational research · 2023Article
- Retrospective Impact Evaluation Continuing to Prove Challenging Irrespective of Setting: A Study of Research Impact Enablers and Challenges Cloaked as an Impact Evaluation? Comment on "'We're Not Providing the Best Care If We Are Not on the Cutting Edge of Research': A Research Impact Evaluation at a Regional Australian Hospital and Health Service".International journal of health policy and management · 2023Article
- The challenges of keeping clinicians unaware of their participation in a national, cluster-randomised, implementation trial.BMC medical ethics · 2022Article
- Difficulties experienced by endodontics researchers in conducting studies and writing papers.Restorative dentistry & endodontics · 2022Article
- How ethics committees and requirements are structuring health research in the Philippines: a qualitative study.BMC medical ethics · 2021Article
- Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.BMC medical ethics · 2019Article
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Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMulti-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.
methodsWe collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.
resultsThe total costs of gaining approval were 38 % of the budget for a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.
conclusionsImprovements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked.
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