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Cited by 56Ethics in Clinical ResearchEthics and bioethics in healthcareStatistical Methods in Clinical Trials

The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders

Open access
on behalf of the Ethics of Pragmatic Trials project, Nicholls, Stuart G., Carroll, Kelly, Zwarenstein, Merrick, Brehaut, Jamie C., Weijer, Charles, Hey, Spencer P., Goldstein, Cory E. +5 more·2019·Trials
DOI 10.1186/s13063-019-3899-xPMC PMC6929346
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Abstract

BACKGROUND: There is a concern that the apparent effectiveness of interventions tested in clinical trials may not be an accurate reflection of their actual effectiveness in usual practice. Pragmatic randomized controlled trials (RCTs) are designed with the intent of addressing this discrepancy. While pragmatic RCTs may increase the relevance of research findings to practice they may also raise new ethical concerns (even while reducing others). To explore this question, we interviewed key stakeholders with the aim of identifying potential ethical challenges in the design and conduct of pragmatic RCTs with a view to developing future guidance on these issues. METHODS: Interviews were conducted with clinical investigators, methodologists, patient partners, ethicists, and other knowledge users (e.g., regulators). Interviews covered experiences with pragmatic RCTs, ethical issues relevant to pragmatic RCTs, and perspectives on the appropriate oversight of pragmatic RCTs. Interviews were coded inductively by two coders. Interim and final analyses were presented to the broader team for comment and discussion before the analytic framework was finalized. RESULTS: We conducted 45 interviews between April and September 2018. Interviewees represented a range of disciplines and jurisdictions as well as varying content expertise. Issues of importance in pragmatic RCTs were (1) identification of relevant risks from trial participation and determination of what constitutes minimal risk; (2) determining when alterations to traditional informed consent approaches are appropriate; (3) the distinction between research, quality improvement, and practice; (4) the potential for broader populations to be affected by the trial and what protections they might be owed; (5) the broader range of trial stakeholders in pragmatic RCTs, and determining their roles and responsibilities; and (6) determining what constitutes "usual care" and implications for trial reporting. CONCLUSIONS: Our findings suggest both the need to discuss familiar ethical topics in new ways and that there are new ethical issues in pragmatic RCTs that need greater attention. Addressing the highlighted issues and developing guidance will require multidisciplinary input, including patient and community members, within a broader and more comprehensive analysis that extends beyond consent and attends to the identified considerations relating to risk and stakeholder roles and responsibilities.

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Authors
on behalf of the Ethics of Pragmatic Trials project, Nicholls, S. G., Carroll, K., Zwarenstein, M., Brehaut, J. C., Weijer, C., Hey, S. P., Goldstein, C. E., Graham, I. D., Grimshaw, J. M., McKenzie, J. E., Fergusson, D. A., & Taljaard, M.
Affiliations
  • Ottawa Hospital Research Institute (CA)
  • Western University (CA)
  • University of Ottawa (CA)
Corresponding author
Nicholls, Stuart G.
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2019-12
Volume
20
Issue
1
Pages
765-765
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/s13063-019-3899-x
PMC
PMC6929346
OpenAlex
W2996965444
Cited by
56
References
65
Citations by year
2026: 2 · 2025: 8 · 2024: 5 · 2023: 8 · 2022: 4 · 2021: 15 · 2020: 14
FWCI
7.60
Type
journal article
Language
en
Open access
Licence
Locations
  • Trials (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • Monash University Research Portal (Monash University) (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
  • uO Research (University of Ottawa) (submittedVersion, public-domain)
Funders
Canadian Institutes of Health Research (PJT-153045)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
pragmatic randomized controlled trial, research ethics, informed consent, minimal risk, usual care, stakeholder roles and responsibilities, trial oversight, trial reporting, generalizability of trial results
MeSH terms
Stakeholder Participation, Female, Humans, Informed Consent, Male, Research Design, Research Personnel, Randomized Controlled Trials as Topic, Ethicists, Ethics, Research, Research Subjects, Qualitative Research, Pragmatic Clinical Trials as Topic

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