Clinical Research Directory

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.

CO-creating Novel, Feasible, and Inclusive Research Methods

The lessons researchers learn and evidence researchers discover from research studies are limited by who volunteered as participants in each research study. Currently, research studies do not represent the full diversity of the American people. Community engagement is one method to increase research participation. But, there is a lack of evidence for recommending a particular level of community engagement over others. This team of scientists, physicians, and community members developed an innovative approach to increase full participation of participants in research studies. The proposed project, Co-creating Novel, Feasible, and Inclusive Research Methods (CONFIRM), is designed to test if researchers can increase research participation by creating methods in partnership with the research participants themselves. As the team has conducted research around breast cancer, these researchers have repeatedly encountered Black women who see the importance of the overall topic and want to help people like them. But when they hear about what exactly they have to do as part of the study, they do not volunteer. This team wants to change that. Researchers plan to recruit participants to answer research questions, and then with those volunteers, researchers will decide together on the tasks and activities volunteers will complete in the study. In contrast to how researchers usually do science, this innovative approach switches the order of design and participant recruitment. Researchers enroll and engage volunteers before methods are selected. This team engages research participants as "co-researchers." This word emphasizes the act of carrying out research with/by participants who are not professional researchers, instead of to/about/for them. The team proposes that participants will design a method that is acceptable, feasible, and relevant to themselves and their community. Researchers will recruit 240 participants from community sites, such as health fairs, retail stores, churches, and schools, who will be divided into two groups based on where they signed up for the study. Half of the participants will complete research procedures (survey, health measurements, blood draw) as the research team designed them before the study started. The other half of participants will work with the research team to adjust the procedures to be acceptable and relevant to the participants before completing the revised procedures. Researchers predict that the group of participants who co-design procedures will have a higher completion rate of inidividual items and stay in the study for longer than the group of participants who complete the pre-designed procedures. By demonstrating the effectiveness of this innovative approach, researchers aim to empower people to become more involved in research.