Validating the Clinical Research Nursing Domain of Practice: A Delphi Technique Study

Researchers in Bethesda, United States have developed and validated a taxonomy for the domain of clinical research nursing through a study involving expert panels and surveys. The study aimed to identify the activities performed by nurses in a clinical research setting and validate a taxonomy for the specialty. The findings revealed five dimensions and 52 activities, including clinical practice, study management, care coordination, human subjects protection, and contributing to science. These dimensions and activities provide a framework for comparing roles across settings, defining competency requirements, and guiding nursing organizations in the development of specialty certification.

Key Takeaways:

  • The study involved a purposefully selected expert panel of 22 nurses who were actively practicing or supervising in a clinical research environment.
  • The research team synthesized peer-reviewed articles, academic curricula, professional guidelines, position descriptions, and expert opinion to develop the taxonomy.
  • The Delphi technique was used to validate the taxonomy through three sequential questionnaires completed over five months.
  • The validated taxonomy consists of five dimensions: 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).
  • The study identified nursing activities that are unique to clinical research settings and highlighted the integral role of nurses in the clinical research enterprise.
  • The validated taxonomy 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.

Statistics:

  • 22 expert nurses participated in the study, including those who were actively practicing or supervising in a clinical research environment.
  • Three sequential questionnaires were completed over a period of five months using the Delphi technique.
  • The validated taxonomy consists of 52 activities across five dimensions: 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).

Sources:

  • Castro, K., et al. (2011). Validating the Clinical Research Nursing Domain of Practice. Oncology Nursing Forum, 38(2), 215.
  • National Cancer Institute. (n.d.). Clinical Research.
  • Oncology Nursing Society. (n.d.). Oncology Nursing Forum.