Title: Developing an inclusive health research system: a realist evaluation of participation in health research with people of African-Caribbean heritage in the UK.
Funder: Health Education England

Abstract: Background People of diverse ethnic and cultural backgrounds in health research are under-served. The INCLUDE project suggests that people are under-served when they have lower inclusion in research and there is a lack of research specifically designed for groups with poorer health outcomes12. This is a serious issue demanding urgent action, recognised by the NIHR. People of African-Caribbean heritage are at greater risk of long-term diseases, poorer health outcomes and experience higher mortality rates. Greater representation is needed to ensure outcomes improve, findings of health research are valid and generalisable, and resources and services are distributed fairly. Without this, there is an incomplete picture of how symptom presentation, disease progression and treatment effectiveness may differ. There is a lack of evidence to inform research funding, policy, design and delivery on what works, for whom, how and under what circumstances around the experience of participation in health research with this group. The term 'people of African-Caribbean heritage' recognises the history, heritage and existence of those who identify as Caribbean and trace their ancestry partially, or fully to Sub-Saharan Africa. Over-arching Aim: Co-produce principles, recommendations and resources facilitating the development of an inclusive health research system. Research questions (RQs): RQ 1. What experiences do people of African-Caribbean heritage have of participating in health research and how can these be improved? RQ 2. What are the perceived barriers and facilitators to participation in health research for people of African-Caribbean heritage? RQ 3. What should inclusive health research look like for people of African-Caribbean heritage? Methods and analysis Taking a realist approach, this study comprises five work packages (WP): (WP1 months 1-36) establishing and embedding co-production to enable the voices of people from an African-Caribbean background (WP 2 months 2-12) conducting a realist review to identify (C) context (M) mechanism (O) outcome (CMO) configurations to develop an initial programme theory (IPT) around experiences of participation in health research (WP 3 months 13-29) refine and test Initial Programme Theory through realist interviews and focus groups (WP 4 months 29-33) carry out four workshops to create a conceptual model of final programme theory to inform the co-design of principles, resources and recommendations, which will be piloted resources with stakeholders. (WP 5 months 2-36) work with communities and collaborators to disseminate the evidence and implement the principles, recommendations and resources.Anticipated impact and dissemination The NIHR Fast Track toolkit will structure planning and delivery of impact through community engagement, scientific and policy-level engagement. A co-produced, conceptual framework will inform the development of principles, recommendations and resources to make adaptations required at each level of the health research system. This will support the NIHR's ambitions for equality, diversity and inclusion, aligning with the work of the INCLUDE project, Race Equality Public Action Group (REPAG), whilst feeding into the evidence base of the NHS Race and Health Observatory. Delivery timeline Co-production (WP1), impact and dissemination (WP5) will be woven throughout the project, whilst Work Packages 3 to 5 will lead to achieving the over-arching aim (see Timeline upload).

Lay abstract: (This summary has been co-written with the Applicant's Patient Public Mentor.) People of African-Caribbean heritage are not well represented in health research.. This includes people who identify as Caribbean, tracing some, or all of their ancestry to Sub-Saharan Africa. The lack of inclusion of African-Caribbean people in health research can have serious consequences on the safety of treatments, and how well they may work. Little is known about their experience of participation in health research. Aim The aim is for people of African-Caribbean heritage to tell the researcher what works, what does not work, and what affects their decision-making, to make research more inclusive. Background It is unknown how many people of African-Caribbean heritage take part in research. Researchers have not routinely collected this information .There is some evidence to suggest it is not very many. Possible reasons like mistrust, stigma, lack of cultural appropriateness and experiences of racism in the NHS affect the decision to take part in health research. There are also reasons that may be hidden. There is not enough known about the experience of health research that people of African-Caribbean heritage may have. If more people of African-Caribbean heritage were included in health research it would develop understanding of how diseases and treatments affect them. This is important because, compared to the rest of the population, they experience a higher risk of death from many diseases, such as COVID-19, cancer, heart disease, stroke, type 2 diabetes, high blood pressure, chronic kidney disease and serious mental health conditions. This makes it more important that services meet their needs. Design and methods used This research will help to answer the research question: What experiences do people of African-Caribbean heritage have of participating in health research and how can these be improved?Using realist evaluation, a method of research, is a way to find out how something works and what is needed to make something work e.g. participation in health research. Patient and Public InvolvementThe researcher will work with people of African-Caribbean heritage and other key people, bringing the community to the table' - lay person from the African-Caribbean community. Everyone in the group will have a say in how the research is carried out. This is called co-production. This work will be guided by the National Institute for Health Research principles on co-production 33. The best way to understand the experiences of participation in health research with people of African-Caribbean heritage will be through interviews and focus groups. They will allow the researcher to hear people's own voices and their own words, to uncover issues that really matter. It will be important to hear from people who have, and do not have experience of participation in research. Interviews will be carried out with: people of African-Caribbean heritage who have taken part in health research community leaders who work with people of African-Caribbean heritage church leaders of African-Caribbean heritage researchers with experience of working with people of African-Caribbean heritageand the following individuals, preferably of African-Caribbean heritage: people who deliver health research, like Research Nurses policymakers ethics committee members funders Focus groups will be carried out with people of African-Caribbean heritage who have not taken part in health research to understand their views towards research. Sharing of resultsResults will be shared through community engagement events, social media, study website, scientific journals and conferences. This research will make a difference by creating resources that empower people of African-Caribbean heritage; educate researchers and research delivery staff; provide guidance and recommendations for policymakers and funders of research to adapt the health research environment, improving how we serve African-Caribbean people.

Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: GENERIC HEALTH RELEVANCE