Additional file 2 of Evaluating a tool to improve engagement and recruitment of under-served groups in trials

Additional file 2. Guidance for researchers to involve patient, public and community contributors in the INCLUDE Ethnicity Framework

Additional file 1 of Evaluating a tool to improve engagement and recruitment of under-served groups in trials

Additional file 1. The participant flow diagram

Evaluating a tool to improve engagement and recruitment of under-served groups in trials

Despite substantial awareness that certain groups (e.g. ethnic minorities) are under-represented and under-served in trials, limited progress has been made in addressing this. As well as a public service and ethical duty to recruit and engage under-served groups in relevant research, importantly, there are clear scientific benefits, for example, increased generalisability. The key aims of the current study were to explore the following: general barriers and facilitators to enhancing the recruitment of under-served groups into trials, the usability and value of a specific tool (INCLUDE Ethnicity Framework) to support engagement and recruitment of under-served groups, and ways of engaging diverse patient, public and community involvement and engagement (PCIE) groups. Firstly, researchers completed a brief survey in relation to a specific trial in which they were involved (N = 182, 38% response rate). A second stage involved sampling survey respondents and asking them to complete the INCLUDE Ethnicity Framework and then a remote semi-structured interview (N = 15). Qualitative data were analysed using thematic analysis. Finally, we conducted a consultation process with PCIE contributors primarily to develop guidelines for discussing the INCLUDE Ethnicity Framework with PCIE representatives. Researchers recognised the importance of increasing engagement and recruitment of under-served groups within trials, but varied in their knowledge, ability and commitment to implementation in practice. The INCLUDE Ethnicity Framework was described by some as raising their awareness of how inclusion could be improved. Respondents highlighted a need for shared resources and wider structural change to facilitate such engagement. PCIE was identified, in the survey and interviews, as the most common method of trying to improve recruitment of under-served groups. However, researchers also commonly highlighted that PCIE groups were sometimes not very diverse. There is a need for researchers to consider the funding and time resources required for diverse and inclusive recruitment to trials and for funders to enable this. The INCLUDE Ethnicity Framework can help to raise awareness of inclusion challenges. This study indicates that it is important to take proactive steps to involve relevant under-served groups in PCIE and practical suggestions are made to facilitate this.</p

The views of ethnic minority and vulnerable communities towards participation in COVID-19 vaccine trials.

The COVID-19 pandemic has disproportionately affected Black, Asian and minority ethnic populations and vulnerable groups.1 Ethnic minority communities have 10–50% higher mortality risk compared with those of white ethnicity in the UK and USA.2,3 Those with mental health conditions, homeless people and vulnerable migrants are also at high risk.4,5 If successful, vaccination will provide protection and management of COVID-19, and to ensure optimal uptake and efficacy of vaccination programmes, the involvement of high-risk groups in vaccine trials is crucial. Ethnic minority individuals are, however, generally underrepresented in medical research, and researchers are actively seeking approaches to include more ethnic minorities in COVID-19 vaccine trials.6 There is, therefore, a pressing need to explore perceptions towards participation in vaccine trials amongst ethnic minority and vulnerable communities towards achieving higher recruitment rates