Delineating the role of a cohort of clinical research nurses in a pediatric cooperative clinical trials group.
OBJECTIVE
To describe the roles and responsibilities of the clinical research nurse (CRN).


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


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


METHODS
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.


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


RESULTS
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.


CONCLUSIONS
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.
Nagel
Kim
K
Pediatric Hematology/Hemophilia/Thrombosis Department, McMaster Children's Hospital, Hamilton, Ontario, Canada. nagel@hhsc.ca
Gender
Jamie
J
Bonner
Ann
A
D000328:Adult; D000368:Aged; D001291:Attitude of Health Personnel; D002170:Canada; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000451:nursing*; D003625:Data Collection; D006801:Humans; D007258:Informed Consent; D008875:Middle Aged; D024802:Nurse's Role / Q000523:psychology; D009730:Nursing Assessment; D015404:Nursing Methodology Research; D009740:Nursing Staff / Q000458:organization & administration* / Q000523:psychology; D009859:Oncology Nursing / Q000458:organization & administration*; D010347:Patient Care Planning; D018579:Patient Selection; D010371:Pediatric Nursing / Q000458:organization & administration*; D017009:Professional Autonomy; D012108:Research Personnel / Q000458:organization & administration* / Q000523:psychology; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D014481:United States