ArticleClinical trials (London, England)2022
Practical steps to identifying the research risk of pragmatic trials.
Article in Clinical trials (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Parent perspectives on neonatal research without prior consent: a mixed-methods interview study.BMC medical ethics · 2026Article
- Reflections on a Principal of Research Ethics: Tom Beauchamp, Moral Specification, and Waivers of Informed Consent.The American journal of bioethics : AJOB · 2026Article
- What constitutes risk in implementation research? Perspectives from a qualitative key-informant study.Implementation science communications · 2026Article
- Ethical considerations in implementation research: a scoping review of key principles, unintended consequences, and emerging ethical guidance.Implementation science communications · 2025Review
- Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials.Journal of medical ethics · 2025Article
- Landscape of informed consent practices and challenges in point-of-care clinical trials.Learning health systems · 2025Article
- Ethical considerations for sharing aggregate results from pragmatic clinical trials.Clinical trials (London, England) · 2025Article
- Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers.BMJ open · 2025Review
- Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent.Clinical trials (London, England) · 2024Article
- Ethical issues in implementation science: perspectives from a National Heart, Lung, and Blood Institute workshop.Implementation science : IS · 2024Article
- Design, implementation, and inferential issues associated with clinical trials that rely on data in electronic medical records: a narrative review.BMC medical research methodology · 2023Review
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2 authors.
Funding
Abstract
backgroundPragmatic randomized clinical trials that compare two or more purportedly "within the standard of care" interventions attempt to provide real-world evidence for policy and practice decisions. There is considerable debate regarding their research risk status, which in turn could lead to debates about appropriate consent requirements. Yet no practical guidance for identifying the research risks of pragmatic randomized clinical trials is available.
methodsWe developed a practical, four-step process for identifying and evaluating the research risk of pragmatic trials that can be applied to those pragmatic randomized clinical trials that compare two or more "standard of care" or "accepted" interventions.
resultsUsing a variety of examples of standard of care pragmatic randomized clinical trials (ranging from trials comparing: insurance coverage conditions, patient reminders for health screens, intensive care unit procedures, post-stroke interventions, and drugs for life-threatening conditions), we illustrate in a four-step process how any pragmatic randomized clinical trial purportedly comparing standard interventions can be evaluated for their research risks.
conclusionAlthough determining the risk status of a standard of care pragmatic randomized clinical trial is only one necessary element in the ethical oversight of such pragmatic randomized clinical trials, it is a central element. Our four-step process of pragmatic randomized clinical trial risk determination provides a practical, transparent, and systematic approach with likely low risk of bias.
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