Defining Clinical Research Nursing Practice: Results of a Role Delineation Study

Abstract

Clinical research nursing is a specialty nursing practice focused on the care of research subjects and implementation of clinical research. A five-dimensional model (Clinical Practice [CP], Study Management, Care Coordination and Continuity, Contributing to the Science [CS], Human Subjects Protection) has been validated nationally to represent the domain of clinical research nursing practice. The purpose of this study was to describe the frequency and importance of activities within each dimension as performed by nurses in clinical research and to describe differences between roles. One thousand and four nurses from the NIH Intramural Campus in Bethesda, Maryland, were invited to participate in an anonymous web-based survey. Participants (N = 412) were predominantly female (90%) with ≥11 years research experience (70%). Two hundred eighty-eight respondents (70%) identified themselves as clinical research nurses (CRNs) and 74 (18%) as research nurse coordinators (RNCs). CP activities were reported most frequent and important whereas CS activities were least frequent and important. CRN and RNC activity frequency differed across all dimensions (p < 0.001) with CRNs reporting significantly higher levels of CP activities and significantly lower levels in other dimensions. Delineating specialty activities and practice across roles enhances the understanding of nurses’ role in clinical research and provides groundwork for role-based training.

Participation of nurses in the execution of clinical research protocol about technological innovation

“…Among the activities of this dimension, the most important was predicting adverse events, monitoring and planning of actions of direct care to the event (9) , which corroborates with the actions developed in this report.…”

“…They also add that nurses who provide health care or coordinate studies can, according to their expertise, improve the efficiency of investigation, safety of participants and quality of data (8,9) . This was observed in our research.…”

A retrospective pilot study comparing data from monitoring reports to identify staffing influence on protocol deviation rates

“…[15][16][17] The American Nurses Association (ANA) and the International Association of Clinical Research Nurses have copublished Scopes and Standards of Clinical Research Nurses. 18 ANA formally recognized clinical research nursing as a professional nursing specialty.…”

Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators

“…Castro et al (2011) conducted a study to describe the specific role activities performed in each of these five domains. Bevans et al (2011) further differentiated the role activities of nurses working as clinical research nurses, clinical research coordinators (CRCs), and nurse practitioners in clinical research settings.…”

“…Nurses attending a national conference of clinical research nurses were surveyed to explore clinical research nurse perceptions about the activities of nurse clinical research coordinators (NCRCs) and nonnurse clinical research coordinators (NNCRCs), validated the nursing role delineation work of Bevans et al (2011), and also raised concerns about the delegation of clinical activities typically requiring nursing licensure to unsupervised non-nurses (Jones & Wilson, 2014). Findings from this survey additionally suggested role conflict among the NCRC respondents and the need for further research on the delegation of clinical research activities to non-nurse research personnel (Jones & Wilson, 2013).…”