Gaps in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: a citation analysis reveals a need for updated ethics guidelines
Identifying 24 gaps reveals a need to update the Ottawa Statement. Alongside additional gaps identified in ongoing empirical work and through engagement with our patient and public partners, the gaps identified through this citation analysis should be considered in the forthcoming Ottawa Statement update.
Authors
- Julia F Shaw (ORCID: https://orcid.org/0000-0002-9768-1177)
- Emily A. Largent (ORCID: https://orcid.org/0000-0002-7536-5077)
- Sandra Eldridge (ORCID: https://orcid.org/0000-0001-5638-2317)
- Lawrence C. E. Mbuagbaw (ORCID: https://orcid.org/0000-0001-5855-5461)
- Ariella Binik (ORCID: https://orcid.org/0000-0002-1557-9735)
- Peter Tugwell (ORCID: https://orcid.org/0000-0001-5062-0556)
- Vivian Welch (ORCID: https://orcid.org/0000-0002-5238-7097)
- Karla Hemming (ORCID: https://orcid.org/0000-0002-2226-6550)
- Fernando Althabe (ORCID: https://orcid.org/0000-0002-7024-8701)
- Maureen E. Smith (ORCID: https://orcid.org/0000-0001-9480-1092)
- Alex John London (ORCID: https://orcid.org/0000-0002-6450-0309)
- Rieke van der Graaf (ORCID: https://orcid.org/0000-0003-4907-7044)
- Cory E. Goldstein (ORCID: https://orcid.org/0000-0002-0229-5039)
- Mira Johri (ORCID: https://orcid.org/0000-0001-5642-787X)
- Jessica du Toit
- Monica Taljaard (ORCID: https://orcid.org/0000-0002-3978-8961)
- Charles Weijer (ORCID: https://orcid.org/0000-0002-5510-1074)
- Katie Gillies (ORCID: https://orcid.org/0000-0001-7890-2854)
- Jamie Brehaut (ORCID: https://orcid.org/0000-0002-4213-1143)
- Shaun P. Treweek (ORCID: https://orcid.org/0000-0002-7239-7241)
- Nicholas B. Murphy (ORCID: https://orcid.org/0000-0003-0137-9238)
- Stuart G. Nicholls (ORCID: https://orcid.org/0000-0003-0485-9069)
- Scott Y. H. Kim (ORCID: https://orcid.org/0000-0002-9444-4627)
- Bruno Giraudeau (ORCID: https://orcid.org/0000-0003-3031-8258)
- Rashida A Ferrand
- Lars G Hemkens
- Susan L. Mitchell
Institutions
- Université de Tours (FR)
- Western University (CA)
- University Health Network (CA)
- University of Ottawa (CA)
- Inserm (FR)
- Queen Mary University of London (GB)
- University of Basel (CH)
- University of Toronto (CA)
- University of Aberdeen (GB)
- Birmingham Community Healthcare NHS Trust (GB)
- Ottawa Hospital (CA)
- University Hospital of Basel (CH)
- Cal Humanities (US)
- London School of Hygiene & Tropical Medicine (GB)
- Centre Hospitalier Universitaire de Tours (FR)
- Biomedical Research and Training Institute (ZW)
- Clinical Investigation Center Plurithematic Tours (FR)
- Instituto de Efectividad Clínica y Sanitaria (AR)
- Hebrew SeniorLife (US)
- Public Health Ontario (CA)
- Centre Hospitalier de l’Université de Montréal (CA)
- Bruyère (CA)
- Sciences, Philosophie, Histoire (FR)
- Innovative Research (United States) (US)
- National Institutes of Health Clinical Center (US)
- St. Joseph’s Healthcare Hamilton (CA)
- Université de Montréal (CA)
- Carnegie Mellon University (US)
- University of Pennsylvania (US)
- University of Birmingham (GB)
- Stanford University (US)
- Nantes Université (FR)
- McMaster University (CA)
Publication Details
- Journal
- Research Integrity and Peer Review
- Published
- 2025-06-17
- DOI
- https://doi.org/10.1186/s41073-025-00166-y
- Citations
- 1
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 1.88
Funders
- Canadian Institutes of Health Research