CE: Original Research: The Clinical Research Nurse: Exploring Self-Perceptions About the Value of the Role

Background: Clinical research nursing is an emerging specialty practice. Clinical research nurses (CRNs) work to make protocol-related care safe for the research subjects while simultaneously maintaining protocol fidelity. They must continuously balance the needs of the research subjects and the study requirements. Purpose: The purpose of this qualitative study was to describe CRNs' perceptions of the value of their role. Methods: Two focus groups were conducted with a purposive sample of 18 CRNs. An interview guide consisting of eight open-ended items was used. Data analysis used critical elements from Krueger's systematic steps for analyzing focus group data. Results: Five major themes emerged from 168 coded statements contained within the focus group transcripts: comprehensive nursing care of research subjects, training and education of research subjects and staff, contributions to clinical science, unique combination of clinical and critical thinking skills, and CRN practice attributes. Subcategories were also identified. In general, participants felt strongly about the value they added. Clinical research nursing requires the use of a variety of abilities and skills, including critical thinking and problem solving, as well as clinical and research knowledge. The CRNs in this study described incorporating these and other elements into their practice, which they associated with their specialized role. The five themes that emerged help elucidate the importance and utility of including CRNs on research teams. Conclusions: The unique combination of applied research knowledge and expert clinical skills sets the specialty of clinical research nursing apart. The study findings, in particular the five themes, provide an evidence-based framework that will be useful in the development of competencies for CRN specialty practice. In helping to bring research findings to bear on clinical care, the impact of CRNs' practice extends beyond the individual patient to larger patient populations.