Understanding Barriers and Facilitators for Ethnic Minority Groups to Audio Recording Recruitment Discussions in Clinical Trials: A Participatory Approach to Improving Informed Consent and Participation

Introduction
Fully informed consent is essential for ethical trial conduct, yet gaps in participant comprehension and recall can occur, particularly among underserved groups, for example, ethnic minorities. This Patient and Public Involvement and Engagement (PPIE) project explored the engagement of ethnic minority communities in trial recruitment discussions, particularly their views about audio recording discussions with healthcare professionals.

Methods
This PPIE project engaged ethnic minority communities in Bristol, collaborating with community partners to facilitate access to then foster dialogue among Somali, South Asian and Chinese groups. Separate workshops for men and women from these ethnic groups were held to introduce community members to clinical trial processes. Discussions, both audio recorded and not, simulated real recruitment scenarios. To ensure cultural relevance and accessibility, discussions were partly facilitated by our PPIE community partners in native languages.

Results
The insights gained during workshops were organised into key themes. Gaps in understanding regarding clinical trial participation were highlighted. A key finding was that trust played an important role and was facilitated by engaging community leaders and ensuring cultural and linguistic sensitivity during discussions. To address gaps in knowledge about trials and streamline the educational process, we developed storyboards and multilingual video resources. These explained the importance of clinical trials generally and the importance of recruiting diverse patient populations in particular. The materials were co-created with community partners and refined through iterative feedback to ensure accuracy and cultural appropriateness. The challenge of language barriers necessitated skilled interpreters, especially when discussions were audio recorded, to optimise understanding among people from diverse ethnic backgrounds. The video, available in English, Urdu, Mandarin, Cantonese and Bangla, facilitates understanding of trial purposes and processes, with the aim of widening trial participation in these groups.

Conclusion
Our PPIE activities highlighted gaps in understanding, the critical role of trust and the challenge of language barriers. The co-created resources have been made available for those wanting to address and overcome some of these issues. The initial feedback from the clinical trials community on the video resources has been promising, underscoring their potential to impact future recruitment efforts and PPIE activities.

Patient or Public Contribution
To foster a co-creation process, this project included the active involvement of our PPIE collaborators and co-applicants ‘Khaas’ for funding. They also helped us reach contributors from the South Asian community (mainly of Pakistani and Bangladeshi origin) and arrange workshops. Our two PPIE contributors from Somali Resource Centre and Barton Hill Activity Club helped us reach the Somali community at the Wellspring Settlement. Similarly, the Chinese Community Wellbeing Society helped us reach people from the Chinese community. These PPIE partners also helped us run the workshop by providing live translation of discussion. They also helped translate video scripts and do voiceovers in videos. Also, PPIE contributors Tom Yardley and Amanda Roberts helped with the script development.