Validating the Clinical Research Nursing Domain of Practice

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.