Co-production of a consensus-based inclusivity checklist to promote inclusion and diversity in clinical research: a multi-method study
5 affiliations
- 1Department of Cardiovascular Sciences, University of Leicester, Leicester, UK
- 2Queen Mary University of London, London, UK
- 3Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
- 4NIHR, London, UK
- 5University of Bristol, Bristol, UK
Abstract
Objectives: To co-produce a consensus-based inclusivity checklist for widening inclusion of under-represented groups and standardising reporting of inclusivity activities in clinical research.
Design: Formal consensus methodology including use of existing frameworks, scoping review, survey, community outreach and consensus development workshop, conducted in line with the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network guidance for reporting guideline development.
Setting: UK clinical research environment, including Clinical Trials Units (CTUs), academic institutions, healthcare settings and community groups.
Participants: Patient and public contributors, including members of under-represented communities, researchers, clinicians, trial managers, CTU staff, funder and equality, diversity and inclusion experts.
Methods: We updated a rapid scoping review of barriers and strategies to increase inclusion in adult clinical trials (MEDLINE, 2021–2024), undertook a national survey of UK Clinical Research Collaboration (UKCRC)-registered CTUs and conducted in-depth discussions with five under-represented community groups. Findings were synthesised using a conceptual framework spanning levels (participant, researcher, organisational, societal) and stages of the research lifecycle. A prototype checklist was developed and refined through iterative stakeholder review and finalised at a 1 day national consensus workshop using structured discussion.
Results: We included 98 articles in the scoping review, identifying a broad but heterogeneous evidence base with limited high-quality evaluations of inclusion strategies. 37 respondents from 21 CTUs completed the survey (41% CTU response rate). The most effective inclusion strategies were perceived to be translation, videos or information in easy to read or visual formats and paying travel costs (32%, 30% and 24% of respondents, respectively). Most respondents stated that budgets were not enough to cover the activities required to recruit people from under-represented groups (64%). The final consensus-based checklist comprises 26 items across six domains: research priority setting, research inclusion planning, study design, delivery, data collection and reporting and dissemination and engagement. Most items were designated core, with optional items to allow flexibility across study contexts.
Conclusions: We developed a practical, consensus-based inclusivity checklist that operationalises existing high-level guidance and supports researchers to embed inclusivity systematically throughout the research lifecycle. The checklist addresses a critical gap between principle and practice and provides a foundation for improving transparency, consistency and equity in clinical research participation.
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- Privilege breeds privilege: a descriptive analysis of medical students’ ethno-racial identity and capital to inform diversity, equity and inclusion in Canadian medical education
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BibTeX
@article{cheng2026coproduction,
title = {{Co-production of a consensus-based inclusivity checklist to promote inclusion and diversity in clinical research: a multi-method study}},
author = {Ann Cheng and Hardeep Aujla and Robert Grant and Chibuzo Mowete and Ali Alhashimi and Jeremy Dearling and Sarah Murray and Sue Page and Esther Mukuka and Gavin Murphy and Maria Pufulete},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-127636},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-127636},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Co-production of a consensus-based inclusivity checklist to promote inclusion and diversity in clinical research: a multi-method study
AU - Ann Cheng
AU - Hardeep Aujla
AU - Robert Grant
AU - Chibuzo Mowete
AU - Ali Alhashimi
AU - Jeremy Dearling
AU - Sarah Murray
AU - Sue Page
AU - Esther Mukuka
AU - Gavin Murphy
AU - Maria Pufulete
PY - 2026
DA - 2026/10/27
JO - BMJ Open
DO - 10.1136/bmjopen-2026-127636
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-127636
AB - Objectives: To co-produce a consensus-based inclusivity checklist for widening inclusion of under-represented groups and standardising reporting of inclusivity activities in clinical research. Design: Formal consensus methodology including use of existing frameworks, scoping review, survey, community outreach and consensus development workshop, conducted in line with the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network guidance for reporting guideline development. Setting: UK clinical research environment, including Clinical Trials Units (CTUs), academic institutions, healthcare settings and community groups. Participants: Patient and public contributors, including members of under-represented communities, researchers, clinicians, trial managers, CTU staff, funder and equality, diversity and inclusion experts. Methods: We updated a rapid scoping review of barriers and strategies to increase inclusion in adult clinical trials (MEDLINE, 2021–2024), undertook a national survey of UK Clinical Research Collaboration (UKCRC)-registered CTUs and conducted in-depth discussions with five under-represented community groups. Findings were synthesised using a conceptual framework spanning levels (participant, researcher, organisational, societal) and stages of the research lifecycle. A prototype checklist was developed and refined through iterative stakeholder review and finalised at a 1 day national consensus workshop using structured discussion. Results: We included 98 articles in the scoping review, identifying a broad but heterogeneous evidence base with limited high-quality evaluations of inclusion strategies. 37 respondents from 21 CTUs completed the survey (41% CTU response rate). The most effective inclusion strategies were perceived to be translation, videos or information in easy to read or visual formats and paying travel costs (32%, 30% and 24% of respondents, respectively). Most respondents stated that budgets were not enough to cover the activities required to recruit people from under-represented groups (64%). The final consensus-based checklist comprises 26 items across six domains: research priority setting, research inclusion planning, study design, delivery, data collection and reporting and dissemination and engagement. Most items were designated core, with optional items to allow flexibility across study contexts. Conclusions: We developed a practical, consensus-based inclusivity checklist that operationalises existing high-level guidance and supports researchers to embed inclusivity systematically throughout the research lifecycle. The checklist addresses a critical gap between principle and practice and provides a foundation for improving transparency, consistency and equity in clinical research participation.
SN - 2044-6055
SN - 2044-6055
ER -