Validating the Clinical Research Nursing Domain of Practice

Abstract

Purpose/Objectives To develop and validate a taxonomy for the domain of clinical research nursing. Design Survey. Setting Clinical research settings in the United States. Sample A purposefully selected expert panel of 22 nurses who were actively practicing or supervising in a clinical research environment. Methods A study team consisting of nurses with experience in clinical research synthesized peer-reviewed articles, academic curricula, professional guidelines, position descriptions, and expert opinion. Using the Delphi technique, three rounds of surveys were conducted to validate the taxonomy. The three sequential questionnaires were completed over five months. Main Research Variables Activities performed by nurses in a clinical research setting. Findings A taxonomy for clinical research nursing was validated with five dimensions and 52 activities: Clinical Practice (4 activities), Study Management (23 activities), Care Coordination and Continuity (10 activities), Human Subjects Protection (6 activities), and Contributing to the Science (9 activities). Conclusions This study validated activities for direct care providers and nurses with the primary focus of research coordination. The findings identify a variety of activities that are unique to nurses in a clinical research setting. Implications for Nursing Nurses play an integral role in the clinical research enterprise. Validating a taxonomy for the specialty of clinical research nursing allows for roles to be compared across settings, competency requirements to be defined, and nursing organizations to be guided in the development of specialty certification.

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

“…Other nurses are employed by investigators or clinical research companies and are charged with coordinating single or multiple clinical research protocols. Castro et al (2011) defined clinical research nursing practice as having "a focus on the care of clinical research participants and management of a clinical research protocol" (p. 8). Research nurse coordinators manage the operation of an average of six protocols and the care of 80 or more study patients annually (Getz, 2013;Getz, 2009).…”

“…An expert committee of clinical research nurses identified and validated five dimensions that constitute the domain of clinical research nursing practice: (a) clinical practice, (b) care coordination and continuity, (c) study management, (d) human subject protection, and (e) contributing to the science (CRN2010 Clinical Research Nurse Domain of Practice Committee, 2009). 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.…”

Using a Shared Governance Structure to Evaluate the Implementation of a New Model of Care

“…The cornerstone of CRN is the provision and coordination of nursing care for participants in clinical research studies (1). A strategic plan and team structure engaging all leadership in nursing and nursing shared governance, called Clinical Research Nursing 2010 (CRN 2010 ), was established, and groups worked for 4 years to create and validate concept documents, communicate through nursing management and advanced practice nursing structures, and discuss them with staff shared governance (SG) leaders (2). Nursing leadership then turned from the application of the specialty of CRN to the process of planning, delivering, coordinating and evaluating care provided to research participants in the CC.…”

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.…”

“…20,21 Comparative research that demonstrates the RN-CRC contributions (e.g., quality indicators) to informed consenting, eligibility, safety, and endpoint assessment is lacking. 16 Moreover, as the complexity of patient populations, clinical research studies and assessments increase, the requirements for hiring RN-CRCs should be increasing, rather than decreasing. To bridge the gap in research, this pilot study compares quality and safety variables based on the frequency of protocol deviations by RN-CRCs to unlicensed CRCs.…”