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

This PhD explores the views of clinical research nurses (CRNs) and research-patients as they take part in clinical research within their respective roles, i.e., as a specialised staff member and as a patient volunteer. Clinical research is supported by NHS England as the best way to improve patient care by finding out whether a new treatment is better than what is available. CRNs are specialist nurses who manage and coordinate clinical research. CRNs are responsible for the safe running of research; they ensure the right information is collected for the research/trial to be successful. CRNs support the well-being of research-patients, by taking note of any new, or existing healthcare needs of research-patients while they take part in research. CRNs coordinate the activities that research requires, biological samples, scans, documentation. Balancing their responsibility towards research-patients, on the one hand, and research management, on the other, can bring unique challenges for the CRN. CRNs can feel conflicted between these two responsibilities, e.g., when they think that a drug trial, or the research activities in a study is at odds with the research-patient's best interest despite the research-patient's consent to take part in research. CRNs are tasked with maintaining/facilitating recruitment of research-patients, this can be a challenging aspect of their role especially if they feel pressured to approach patients to take part in research. Currently, we know little about how CRNs balance these two responsibilities, or what other problems CRNs have in their everyday role when balancing these responsibilities. Finding out more about these aspects of the CRN role is important because it may not only improve job experience but can also give a better understanding of what can be changed to improve how CRN perform their role which could ultimately improve research-patients' experience of taking part in research. To address this issue, this PhD will explore CRNs and research-patients' views about clinical research, the challenges CRNs face, how CRNs balance their responsibilities, and what role does the relationship between CRNs, and research-patients play overall in what they say about their experience of taking part in clinical research. The researcher will interview and shadow CRNs and research-patients at a central NHS Hospital. This is a LISS/ESRC funded PhD at King's College London and supported by Guy's and St Thomas NHS Foundation Trust.

Inclusion Criteria: INCLUSION CRITERIA FOR RESEARCH-PATIENTS * Research-patients aged above 18 years old. * Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over) at GSTT. * Research-patients who are willing and able to provide informed consent. INCLUSION CRITERIA FOR CRNS Clinical research nurses (CRNs) currently working in adult clinical research at Guys and St Thomas' NHS Foundation Trust. • CRN willing and able to give consent. Exclusion Criteria: EXCLUSION CRITERIA FOR RESEARCH-PATIENTS * Patients who showed an interest in taking part in research but were not recruited, e.g. due to screen failure, or ineligibility. * Research-patients recruited to research via proxy consent, e.g., next of kin. * Patients unable to provide informed consent, e.g., lacking mental capacity. * Research-patients considered vulnerable or at risk of harm, by the research team * Research-patients taking part in mental health or maternity trials or studies * Research-patients not fluent in English or not able to converse well in English EXCLUSION CRITERIA FOR CRNS * Clinical research midwives and clinical research nurses working in mental health, maternity, and paediatric research are excluded from this study. * CRNs not willing or unable to give consent.