The Clinical Research Nurse: A Global Perspective on Role, Value and Leadership

Clinical research nursing is “the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol.” (International Association of Clinical Research Nurses (IACRN), 2012). Description of nurse involvement in clinical research is present in the literature, however, not until the last two decades has significant progress been made in role description and awareness of the specialty practice of the CRN (Fedor, 2009;Watmough, Flynn, & Wright, 2010; Nagel, Gender, & Bonner, 2010). Clinical research nursing is an emerging specialty within the nursing field that has gained attention internationally for its contributions to the safe and ethical care of patients and the accurate, efficient collection of quality clinical research data (Ledger, Pulfrey, & Luke, 2008; Poston & Buescher, 2010; Spilsbury et al., 2008).

The role of the CRN is gaining increased importance globally in light of clinical and translational science becoming a global priority. The CRN is able to focus beyond the research related tasks to continually balance the needs of the participant with that of the protocol (Hastings et al. 2012) thus assuming a leadership role in advancing novel therapeutics and quality patient outcomes.  

The specialty of clinical research nursing incorporates 5 domains of practice, (1) human subject protection; (2) care coordination and continuity; (3) contribution to clinical science; (4) clinical practice; and (5) study management throughout a variety of professional roles, practice settings, and clinical specialties (US Department of health and Human Services, 2009). The value of the contributions that CRNs make to the research enterprise within these domains of specialty practice is not well articulated, therefore in order to move the specialty practice of clinical research nursing forward it is essential that CRNs begin to describe first qualitatively and then quantitatively the value they bring to the domains of the specialty practice and the leadership roles they assume. Mueller 2001, goes one step further and suggests that CRNs need to “empirically demonstrate that the skills and knowledge they bring to clinical research as nurses are qualitatively and quantitatively different, and therefore more beneficial, than those provided by other occupational groups”.

In an effort to begin to clearly articulate the contributions of the CRN to the clinical research enterprise important findings from a recent focus group study of CRNs will be presented and discussed. To add further insight, perspectives from international CRNs will be presented. CRNs are valued members of interprofessional teams practicing globally in culturally diverse settings, all guided by Good Clinical Practice guidelines and sharing the common goals of patient safety and advocacy, quality data collection and protocol fidelity. As CRN specialty practice advances contributions to establishing global standards for CRN practice will be vital. Educational forums are being held globally to educate nurses and other clinical research professionals in an effort to improve the care of the research subject and improve the integrity of clinical research. 

The purpose of this presentation is to provide the learner with (1) a definition of the specialty practice of the Clinical Research Nurse (CRN), (2) a discussion of the role of the CRN, including a global perspective, (3) a presentation of the findings from a recent focus group study describing CRN's perception of the value of their practice on the care of patients enrolled in clinical research and implementation of clinical research and (4) a discussion of strategic initiatives for advancement of the role globally.

References:

Fedor, C.A. (2009).  A trend in nursing:  Professional growth and development of clinical research coordinators.  The Monitor (23)5, pp. 19-21. Retrieved from http://www.nxtbook.com/nxtbooks/acrp/monitor_200909/index.php#/23/OnePage

International Association of Clinical Research Nurses. (2012) "Enhancing Clinical Research Quality and Safety Through Specialized Nursing Practice". Scope and Standards of Practice Committee Report. Retrieved from http://iacrn.memberlodge.org/aboutus

Hastings C, Fisher C, McCabe M. (2011). Clinical Research Nursing: A Critical Resource in the National Research Enterprise. Nursing Outlook, 60: 149-156.  PMCID: PMC22172370

Ledger, T., Pulfrey, A., & Luke, J. (2008). Developing clinical research nurses.  Nursing Management, 15(2), 28-33. 

Nagel, K., Gender, J., & Bonner, A. (2010). Delineating the role of a cohort of clinical research nurses in pediatric cooperative clinical trials group. Oncology Nursing Forum, 37(3), E180-185.

Poston, R.D. & Buescher, C.R. (2010). The essential role of the clinical research nurse (CRN).  Urologic Nursing, 30(1), 55-77.

Spilsbury, K., Petherick, E., Cullum, N., Nelson, A., Nixon, J., & Mason, S. (2008). The role and potential contribution of clinical research nurses to clinical trials. Journal of Clinical Nursing, 17, 549-557. doi: 10.111/j.1365-2702.2006.01972.x

U.S. Department of Health and Human Services, National Institutes of Health Clinical Center, Nursing Patient Care Services. (2009). Building the Foundation for Clinical Research Nursing: Domain of Practice for the Specialty of Clinical Research Nursing. Retrieved from http://www.cc.nih.gov/nursing/crn/DOP_document.pdf

Watmough, S., Flynn, M., Wright, A. & Fry, K. (2010). Research nurse or nurse researcher? British Journal of Cardiac Nursing, 5(8), 396-399.