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Evaluating the feasibility and usability of the INCLUDE framework

What are we trying to do?

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


We are investigating the feasibility and usability of the INCLUDE Ethnicity Framework and the perspectives of researchers on the likely effectiveness of the Ethnicity Framework.


A sub-focus of the work is on the feasibility and usability of the ‘generic’ INCLUDE questions (these are also part of the Ethnicity Framework, but do not focus on ethnic minorities to enable researchers to consider inclusion of a range of under-served groups).



Why is it important?

Some groups of people are under-represented in health and social care research. Under-representation is characterised by lower levels of inclusion in research than population estimates; high healthcare burden that is not matched by the volume of research; and important differences in how a group responds or engages to interventions, services or research. Inclusive research involves under-served groups that the results of the research could apply to; for example, identifying which individuals from under-served groups should be able to access an intervention or treatment that is being evaluated.


Inclusive research also takes proactive steps to involve these under-served individuals and groups.  As well as a public service and ethical duty to include under-served groups, there are also clear scientific benefits to inclusive research.  For example, ensuring trial results are generalisable to the relevant wider population and that important findings specific to different populations are not missed.


Therefore, trial teams need to do everything possible to make their research relevant to the people for whom the results are intended to apply (often patients) and those expected to apply them (often healthcare professionals).


How will we do it?

We will address four research questions:


  1. What activities do researchers currently undertake to consider under-served groups in their trials?
  2. How feasible and useable do researchers find application of the INCLUDE Ethnicity Framework to their particular study?
  3. What are researcher views on the potential usefulness and effectiveness of the INCLUDE Ethnicity Framework in terms of meeting the overall aims of engaging with, and improving inclusion of, under-served groups in clinical research?
  4. What additional content or resources do researchers think could enhance the INCLUDE Ethnicity Framework’s comprehensiveness and usability (e.g. tips, links to other resources)? 


To address the four research questions we are using a short electronic survey of Chief Investigators of relevant research studies, by this we mean randomised controlled trials that are either being prepared for, or funded by the NIHR Research for Patient Benefit (RfPB),  Invention for Innovation (I4I), Efficacy and Mechanism Evaluation (EME) and Health Technology Assessment (HTA) funding streams. We will ask questions about how Chief Investigators  currently consider under-served groups in their study planning.


We will also ask respondents to indicate whether they are willing to pilot the use of the INCLUDE Ethnicity Framework in their current study. If they agree, they will be contacted again to take part in a modified think aloud assessment of their INCLUDE Ethnicity Framework use and a short qualitative interview.


Who are we working with?



For more information:

If you would to know more about this work, please contact Ross Atkinson (Programme Manager)