Reporting Research Inclusion

Embedding Research Inclusion within NIHR's research, systems and culture is a strategic focus as set out in Best Research for Best Health: The Next Chapter. NIHR recognises in order for everyone in the UK to benefit from research, there needs to be an understanding of how interventions work on different groups of people and how the research is conducted.

As of autumn 2024, the NIHR therefore requires all applicants for domestic programme awards to detail how they will ensure inclusion is considered and built into the whole research lifecycle.  More information can be found at the following link Inclusive research design to become an NIHR condition of funding.

In support of this commitment, as a Journals Library author, you are expected to report on research inclusion within your Journals Library publications, and it is a mandatory heading within your Synopsis or Extended Research Article. You should also report research inclusion in your Research Articles if and when appropriate. You should describe how EDI has been considered and incorporated into the research award and how it has been reflected within your award team and authors. 

Why ‘research inclusion’?

We use research inclusion to highlight NIHR’s mission of addressing inequalities related to various characteristics. Beyond the protected characteristics of the Equality Act 2010, we include disparities linked to socio-economic status, geographic location, and access to health and care. Considering all relevant characteristics is key to our goal of improving the nation's health and wealth through research. At NIHR, research inclusion means applying an inclusive lens throughout the research process. The Journals Library are committed to publishing research that:

• tackles long-standing structural barriers that hinder certain groups from contributing to, participating in, and delivering research
• reduces health and care inequalities
• is inclusively designed and analysed, with methods suited to the target participants; and
• addresses the needs of diverse, under-served, under-represented groups, or those with the highest needs.

Research inclusion is a broad topic, and the Journals Library will continually review and update the guidance in line with its stakeholders. Please see below suggested areas for you to consider as part of your manuscript write up.

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 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 demographics 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 participants 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 the 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

• What demographic data or other data relevant to research inclusion was collected?
• Have you specified the planned analysis of inclusion data in your statistical analysis plan?
• 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?

To aid with the writing of this section please utilise the following frameworks that the NIHR has developed to help our studies be more inclusive. There are also a multitude of resources on these sites for you and your award team's own development around equality, diversity and inclusion.

The INCLUDE Framework – Provides a road map showing when it might be possible to include under-served groups during the course of research

The INCLUDE ETHNICITY Framework - Aims to help study teams think carefully about which ethnic groups should be included in their study for its results to be widely applicable, and what challenges there may be to making this possible.

Other useful guidelines you may want to consider are:

Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use - Reporting of sex and gender information in study design, data analyses, results and interpretation of findings.