Clinical Research Nursing Landmark Documents
Domain of Practice | Model of Care
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. The goal was 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 patients. In addition to providing and coordinating clinical care, clinical research nurses have a central role in assuring patient safety, ongoing maintenance of informed consent, integrity of protocol implementation, accuracy of data collection, data recording and follow up. Care received by research patients 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 included 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 patients. 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 included two parallel efforts:
- A careful and thorough documentation and clarification of the practice of clinical research nursing here at the Clinical Center, and
- The formal development and consensus around steps leading to possible national certification.
Both efforts used a team structure that included all leadership members of the Nursing Department Leadership as well as nursing Shared Governance chairs and co-chairs. 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 patient 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 Clinical Center and Institute nurses as well as nurses in clinical research from across the country.
In 2016, the American Nurses Association recognized Clinical Research Nursing as a specialty practice and published the Clinical Research Nursing: Scope and Standards of Practice.