Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS (SHARE)

The purpose of this study is to explore how research patients and Clinical Research Nurses (CRNs) describe their experiences of participating in clinical research within their respective roles.

The study involves two main activities:

1. Interviewing CRNs and research-patients via online (separately). Semi-structured interviews will be conducted using an interview guide based on themes identified in the existing literature. The guide will be refined and finalised based on feedback from Patient and Public Involvement and Engagement (PPIE), as discussed in the PPI section of the IRAS application.
2. Observations of research activities at research departments including research consultations between CRNs and research-patients.

Research activities refer to various assessments or tasks carried out to generate data for a research protocol. The CRN's role includes conducting these activities, which may involve obtaining patient consent, collecting biological samples (e.g., blood, urine), or dispensing experimental drugs as part of a clinical trial. These activities typically occur during 'research visits' which are appointments or consultations between the CRN and the research patient.

The researcher will observe research activity taking place in research departments by way of "observer placements" for up to five days. Placements can occur in any of the following research departments: gastrointestinal, liver, surgical, respiratory, diabetes and endocrinology, neurology, renal, gynaecology, rheumatology, cardiovascular imaging, and lupus, ageing and health. This wide range of departments has been intentionally selected to provide a broad perspective and to maximise exposure to diverse research activities across different disease specialities. These observation placements will allow the researcher to directly observe interactions between CRNs and research-patients during research activities. Observational data will provide insight into the real-world context in which CRNs and research patients communicate their understandings, expectations, and perceptions of research participation.

Combining observational data with interview data will support triangulation during reflexive thematic analysis.

The number of placements will depend on the opportunities available for the researcher to undertake observations during the PhD data collection period. While the total number of observations is flexible, it is anticipated that this will be in the region of 10-15 due to the overall timeline for completing the PhD. The final number will be informed by guidance from the academic supervisory team during the analysis phase, which will take place concurrently with ongoing data collection. The sample size will be guided by the principle of 'information power'.

Organisation of the observer placements within research departments will be supported by the research leads (research matrons) with whom the researcher has already made prior contact, discussed the aim of the study, and who are supportive and will help to facilitate the project's objectives.