Work

Co-production of a consensus-based inclusivity checklist to promote inclusion and diversity in clinical research: a multi-method study

Year: 2026

Type: article

Abstract: 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.

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-127636