12-19-2016

Regarding: University of Chicago Medicine Nursing Policy 1247,

Clinical Research Involving Nursing Staff and/or Nursing Care

Policy

Nursing Research Council Review is required for all research protocols meeting any one of the following criteria:

  1. A nurse is identified as key study personnel*
  2. The department of nursing is anticipated to provide nursingresources for the research such as equipment, medical supplies,or patient care beyond standard nursing care (e.g. additional procedures, increased monitoring of patient)
  3. Nurses are identified in the protocol as research subjects

Nursing Research Council Review Determination

The intent of the Nursing Research Council (NRC) Review is to ensure that research involving nurses and/or nursing care has adequate oversight. Studies which do not involve use of nursing resources (nursing labor, nursing supplies), nurses as research subjects, or nurses as lead investigators are exempt from NRC review. To determine if a study requires NRC review, answer the following questions.

  1. Are nurses research subjects in the study?
  2. Yes –NRC review required
  3. No –continue to #2

Example: A study is proposed to determine if using a checklist during rounds improves MD to RN communication. The investigators plan to survey nurses and physicians before and after the intervention regarding their communication surrounding daily patient goals. In this example the answer to question 1 is Yes, so NRC review is required.

Contrary case: A study is proposed to examine patients’ perceptions of nursing care. Only patients are interviewed. In this example, the answer to question 1 is no, so NRC review is not required.

  1. Are nursing resources required beyond standard patient care (nursing workforce, nursing supplies)
  2. Yes –NRC review required
  3. No –continue to #3

Example: A clinical trial requires nursing staff to monitor patient vital signs every 15 minutes for two hours. The standard of care within the organization is to assess vital signs every 4 hours. In this example, the answer to question 2 is yes, so NRC is required.

Contrary case: A clinical trial requires nursing staff to obtain one additional blood specimen during routine lab draws for the patient. In this example, the answer to question 2 is no, so NRC is not required.

  1. Is a nurse lead or co-investigator?
  2. Yes –NRC review required
  3. No –continue to #3

Example: A proposal is submitted with a nurse as PI. In this example, the answer to question 3 is yes, so NRC is required.

Contrary case: A proposal is submitted with a nurse listed as study personnel. The nurse will be responsible for assisting with data collection within her role on the research team. In this example, the answer to question 3 is no, so NRC is not required.

Cynthia LaFondPhD, RN, CCRN

Chair, Nursing Research Council

University of Chicago Medical Center

5841 South Maryland Avenue

Chicago, Illinois 60637

773 702-6082

*Excludes nurses who were hired as study coordinators or research assistants, unless they are conducting research independent of the coordinator/assistant role