Background and Overview
In January, 2007, Clinical Center Nursing at the National Institutes of Health launched a four-year strategic plan to lead an international effort to define the specialty practice of clinical research nursing. Our goal is to take this definition to the level of detail and consensus required to create a certification process for nurses practicing in clinical research. This initiative is called Clinical Research Nursing 2010, or CRN2010.
Clinical research nursing is nursing practice with a specialty focus on the care of research participants. In addition to providing and coordinating clinical care, clinical research nurses have a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation , accuracy of data collection, data recording and follow up. Care received by research participants is driven by study requirements and the collection of research data as well as clinical indications. Study procedures may include administration of investigational drugs, performance of an experimental or investigational surgical or radiological procedure, detailed clinical assessment or phenotyping to characterize the natural history and etiology of a disease, or delivery of a psychosocial intervention. Additional nursing care may be necessitated by the response of the participant to the study intervention.
The scope of CRN2010 includes two the main roles assumed by nurses practicing in clinical research settings. Clinical research nurses are clinical staff nurses with a central focus on care of research participants. They support study implementation within the context of the care delivery setting and are primarily located in dedicated clinical research settings, such as the NIH Clinical Center and clinical research units located in academic medical centers across the country. These clinical nurses are part of the permanent infrastructure of the research unit and are available to any investigator accessing the facility. Research nurse coordinators are primarily responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting. Research nurse coordinators are often hired by and report to a principal investigator for support of a specific study or group of studies. They may rely on clinical staff to deliver “hands on” care including administration of investigational drugs or interventions.
Developing tools to support the specialty practice of clinical research nursing includes two parallel efforts: (1) a careful and thorough documentation and clarification of the practice of clinical research nursing here at the Clinical Center, and (2) the formal development and consensus around steps leading to possible national certification. Both efforts have used a team structure that includes all leadership members of Nursing and Patient Care Services Leadership as well as nursing Shared Governance chairs and co-chairs. Each year since 2007, “2010 Teams” have been charged with specific outcomes that have moved us towards our goal.
Examination of the Clinical Center practice of clinical research nursing began with a clarification of our model of nursing care delivery, roles across the department and several key processes of clinical care such as research participant education and clinical documentation. Development of a specialty identity which can lead to certification began with a clarification of the domain of practice. This is similar to the steps taken by various specialty groups ranging from oncology nursing to informatics nursing. The CRN domain includes 5 dimensions and about 50 individual activities which make up the full range of practice of both clinical nurses providing research-based patient care and study coordinators managing studies. This domain description was validated in 2008 with the assistance of a consensus panel representing CC and IC nurses as well as nurses in clinical research from across the country. We now have eight 2009 CRN2010Teams charged with taking the domain to the next level of application, including competency assessment, course development and a framework for clinical documentation.
To date, CRN2010 has been moved forward by the leadership group within Clinical Center Nursing. This year we are extending the effort to include nursing colleagues from the institutes and Clinical Center departments as well as colleagues from other disciplines. We are also undertaking a systematic and thorough communication and dissemination process to take the results from our efforts so far to the clinical research staff here and across the country for feedback, validation and possible implementation.
Here at the Clinical Center the dissemination process will begin with a thorough validation though our nursing shared governance process of the proposed Model of Care for Clinical Research Nursing. This model represents a recommitment to the principles that have supported a 30+ year history of primary nursing within our organization as well updating the application of those principles for our current practice environment. Our goal is to reach every nurse in clinical research practice at the Clinical Center. We want each nurse to have an opportunity to provide input and gain an understanding of all the roles of clinical research nurses in providing, planning and managing care for our patient volunteers as they move throughout our setting, from ambulatory clinics, to day hospitals to procedure areas, inpatient units and critical care. Validation and implementation of the Model of Care will be launched in April, 2009 and will be a major focus for the rest of the year.
Clare Hastings, RN, PhD, FAAN
Chief Nurse Officer
NIH Clinical Center