Inclusivity Checklist for Clinical Research

Background

People who participate in clinical trials are not representative of the general population with medical conditions. Women, people who are not White, are elderly, disabled or have multiple long-term conditions and people who live in less favourable social and economic circumstances are less likely to be recruited. This means that trial results may not apply to them. People from these under-represented groups have poorer health, less access to healthcare, and are more likely to experience poor outcomes. 

The National Cardiac Surgery Clinical Trials Initiative aims to improve and widen participation from under-represented groups in clinical research. We have created a Checklist of strategies to promote greater inclusion and diversity in clinical research, titled 'Inclusivity Checklist for Clinical Research'.

How we developed the Inclusivity Checklist

Review of the literature to identify studies that investigated why people from under-represented groups are less likely to participate in research and which strategies researchers can use to promote their inclusion.

Survey with UK Clinical Trials Units (specialised units that design, conduct, analyse and publish research studies) to find out which strategies they use to improve inclusivity in their research studies

Community Outreach with the NIHR Biomedical Research Centre Dance and Health Programme and AGE UK in and around Leicester to ask about barriers and facilitators to research participation within these groups

Consensus Workshop with multiple stakeholders to determine the final content of the Checklist

Ongoing Development

The Inclusivity Checklist is now undergoing pilot testing and evaluation.  We welcome any feedback and experience you may have in using the Inclusivity Checklist in your own research. 

Contact

heartsurgerypsp@leicester.ac.uk

Downloads

• Inclusivity Checklist (fillable PDF, 210kb) Last update Version 2.0 2025/03/25
• Full guidance on using the Inclusivity Checklist (PDF, 775k), including case studies and additional resources in cardiovascular research)

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