ArticleClinical trials (London, England)2015
The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials.
Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 4 of them syntheses that pooled it.
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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
41 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Eligibility Criteria of Randomized Clinical Trials in Critical Care Medicine.JAMA network open · 2025Pooled it
- Preparing for pandemics: a systematic review of pandemic influenza clinical management guidelines.BMC medicine · 2022Pooled it
- The effectiveness of COVID-19 vaccines in reducing the incidence, hospitalization, and mortality from COVID-19: A systematic review and meta-analysis.Frontiers in public health · 2022Pooled it
- Applications of Blockchain in the Medical Field: Narrative Review.Journal of medical Internet research · 2021Pooled it
- Combining value of information analysis and ethical argumentation in decisions on participation of vulnerable patients in clinical research.BMC medical ethics · 2018Trial
- Strengthening Indigenous community engagement in clinical research: a formative evaluation in Northern British Columbia.BMJ global health · 2026Article
- Bridging disciplinary siloes: a scoping review on the inclusion and exclusion of pregnant and lactating populations in clinical research.BMJ public health · 2026Article
- Barriers and Facilitators for Equitable Clinical Research Among Pragmatic Trialists: A Qualitative Study.Pragmatic and observational research · 2026Article
- "The hardest part of what we're doing": research staff perspectives on engaging marginalized populations in substance use trials.Substance abuse treatment, prevention, and policy · 2025Article
- Article
- Are pragmatism and ethical protections in clinical trials a zero-sum game?Clinical trials (London, England) · 2025Article
- Application of Quantitative Systems Pharmacology Approaches to Support Pediatric Labeling in Rare Diseases.Handbook of experimental pharmacology · 2025Review
- Will artificial intelligence widen the therapeutic gap between children and adults?Pediatric investigation · 2024Article
- Algorithmic identification of persons with dementia for research recruitment: ethical considerations.Informatics for health & social care · 2024Article
- Establishing a Pregnancy Lyme Disease Biobank.Methods in molecular biology (Clifton, N.J.) · 2024Article
- IRBs and the Protection-Inclusion Dilemma: Finding a Balance.The American journal of bioethics : AJOB · 2023Article
- Establishing the safety of selective digestive decontamination within the ICU population: a bridge too far?Trials · 2023Article
- Concordance of neonatal critical condition data between secondary databases: Florida and Texas birth certificate Linkage with medicaid analytic extract.BMC medical research methodology · 2023Article
- Ethical analysis of vulnerabilities in cluster randomized trials involving people living with dementia in long-term care homes.Journal of the American Geriatrics Society · 2023Article
- Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems.Learning health systems · 2022Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
Policies have been developed to protect vulnerable populations in clinical research, including the US federal research regulations (45 Code of Federal Regulations 46 Subparts B, C, and D). These policies generally recognize vulnerable populations to include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. The aim has been to protect these populations from harm, often by creating regulatory and ethical checks that may limit their participation in many clinical trials. The recent increase in pragmatic clinical trials raises at least two questions about this approach. First, is exclusion itself a harm to vulnerable populations, as these groups may be denied access to understanding how health interventions work for them in clinical settings? Second, are groups considered vulnerable in traditional clinical trials also vulnerable in pragmatic clinical trials? We argue first that excluding vulnerable subjects from participation in pragmatic clinical trials can be harmful by preventing acquisition of data to meaningfully inform clinical decision-making in the future. Second, we argue that protections for vulnerable subjects in traditional clinical trial settings may not be translatable, feasible, or even ethical to apply in pragmatic clinical trials. We conclude by offering specific recommendations for appropriately protecting vulnerable research subjects in pragmatic clinical trials, focusing on pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.
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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.