Dixie D Thompson

Title : Clinical research nursing: Scope and standards of practice – how ANA recognition is elevating clinical research nursing at the University of Utah and at your organization

Abstract:

In 2016 the American Nurses Association (ANA) and the International Association of Clinical Research Nurses (IACRN) co-published the first-ever Clinical Research Nursing (CRN) professional standards. The ANA officially approved Clinical Research Nursing as a specialty, and acknowledged the scope and standards of practice for that specialty. This approval will remain valid until 2021. IACRN aims to leverage this new specialty recognition towards creating a specialty practice certification specific for Clinical Research Nurses.

The publication authoritatively defines five domains of practice for the Clinical Research Nurse: Human Subjects Protection; Care Coordination and Continuity; Contribution to Science in General and Nursing Science/Practice; Clinical Practice; and Study Management. The publication also includes 17 Standards of Professional Performance in Clinical Research Nursing.

Roles for a CRN are increasingly varied and complex. Roles include Clinician, Manager, Educator, Advocate, Regulatory Specialist and Nurse Scientist. Each role requires clinical research registered nursing competencies in each of the 17 professional standards, regardless of role, population or specialty.

The published scope and standards of practice are a scholarly demonstration of the value and specific niche for clinical research registered nursing in clinical trials, and provides competency landmarks for registered nurses working in any aspect of clinical research: from the bedside clinician contributing to performance of a clinical trial to the nurse scientist serving as Principal Investigator. The value of including clinical research registered nurses in clinical research lies in layering the scope and standards of practice over the established critical thinking model known as the nursing process.

The University of Utah Center for Clinical & Translational Science has defined an organization structure and clinical research staffing model that maximizes use of the CRN competencies and licensure; has supplemented staffing with non-licensed personnel in appropriate environments and populations; and is building an annual performance evaluation process around CRN self-assessment of competencies of all 17 standards of CRN practice. Additionally, the published scope and standards of practice are informing quality improvement systems, evaluation of nursing delivery systems, staff position descriptions, and Clinical Research Unit (CRU) policies, procedures, protocols, and educational offerings.

Biography:

Ms. Thompson is Executive Administrative Director of the Liaison Team, Center for Clinical and Translational Science, University of Utah, and program director for the CCTS and the Trial Innovation Center. She is a clinical research management professional with over thirty years’ experience in research nursing, trials performance and research coordination. She is a former CRU Nurse Manager, Clinical Nurse Educator, and Clinical Nurse Specialist. Her role in the Trial Innovation Network as Liaison Team Network Lead includes monthly contact with 64 academic centers and their Liaison Team staff, where she mentors and facilitates bidirectional communications to engage each site with this new Network. Ms. Thompson is a certified Six Sigma Green Belt and was trained in Physician Lean Health Care methodology through University of Utah Health, and loves applying lean methodology to the big questions in clinical research strategy and operations.