Delineating the role of a cohort of clinical research nurses in a pediatric cooperative clinical trials group.

PURPOSE/OBJECTIVES: To describe the roles and responsibilities of the clinical research nurse (CRN).

DESIGN

A descriptive design was used to reveal the roles of pediatric oncology CRNs.

SETTING

The Children's Oncology Group (COG) password protected Web site.

SAMPLE

85 nurses who performed clinical research associate work within COG.

METHODS

The Clinical Trials Nursing Questionnaire was used to investigate the roles and responsibilities of CRNs.

MAIN RESEARCH VARIABLES

Protocol assessment, protocol planning, subject recruitment, informed consent process, investigational product, implementation and evaluation, data management, and professional nursing role.

FINDINGS

The study found that 55% of respondents (n = 47) were employed in a hospital setting, the majority (81%) had more than five years of oncology experience, and the average age of respondents was 45.56 years (range = 24-65 years). CRNs rated all role components as very important, with the consent process being of greatest importance. Eighty-nine percent reported experiencing autonomy and independence in the role.

CONCLUSIONS

Clinical specialization of RNs has increased significantly in the past several decades. Acknowledging that nurses are responsible for performing many different roles that are critical to the successful completion of clinical trials is crucial.

IMPLICATIONS FOR NURSING

Evaluation of this dual role is still in its infancy, but articulating the role of CRNs in the conduct and context of clinical research is an important first step.