Language and Terminology

• How have you used language and terminology to make the research inclusive? What principles have you taken in your approach to enable inclusivity and why?

Consideration of the disease burden, epidemiology, presentation and outcomes the population groups and any differences in the application of existing preventative, screening or diagnostic strategies and treatments.

• What were the characteristics/demographics of the population which your research looked to serve?
• Did the target of research (disease, disorder or intervention) impact or affect different groups in a different way? What data did you review to investigate this?
• Do the existing preventative, screening or diagnostic strategies and treatments impact or affect different groups in a different way? What data did you review to investigate this?

Generalisability and transferability of evidence

• Describe the generalisability/transferability of evidence on safety and effectiveness across the population groups considered in the study design and study population, endpoints, expected geographic location of trials/studies, language or literacy considerations for resources and research team.
• What evidence do you have that your intervention is feasible and accessible to a broad range of patients in the populations that your research seeks to serve?

Participant representation

• Reflect on the important population characteristics for your study. What active steps were taken to optimise participation, retention of relevant people/groups and sustained community engagement (e.g., community advisory boards and navigators, community health workers, patient advocacy groups, local healthcare providers, etc.)? 
• What was your inclusion/exclusion criteria to enable your trial population to match the population that you aim to serve?
• Was the participant population inclusive? Explain further: what worked well? What (if any) were the specific barriers to inclusion? What were the underlying causes of these barriers? What action(s) were taken to overcome these barriers? How could this be addressed in future research?
• If applicable, provide comments on how gaps in representation in prior evidence/data were identified and how these were addressed during the project. Did this research uncover any gaps in knowledge/data during the project? How could this be addressed in future research?

Enrol and retain diverse participants

• How did you reduce burden on participants related to trial/study design/conduct (e.g. number/frequency of study-related procedures, use of local laboratory/imaging, telehealth, consideration of language, literacy, accessibility, transport, community engagement)? 
• How have you made sure text and pictures used as part of participant and public engagement were inclusive and accessible and not discouraging to under-represented groups?
• What metrics did you use to ensure that diverse participants enrolment goals are achieved? Specify actions implemented during the conduct of the trial(s) or studies if planned enrolment goals were not met?
• Who were the under-served groups within your delivery area? (e.g. geographical or disease area that the delivery team operates in)

Participant data

• Have you disaggregated your data (evidence collected) to investigate any differences in the target of research on any of these groups?

Reflections on your research team and wider involvement

• Does your research team include those from groups who are generally under-represented in your field of study? If not, please state why this is the case. 
• Was there a range of experience and expertise across the research team? 
• How were development opportunities provided, particularly for more junior members of the team? 
• Were participants and members of the public involved representative of the disease and geographic areas? What role/s did they provide and how did they benefit the project?