Nursing Service Contract Approval for Research at the VA ECHCS, Denver
COMIRB Protocol # ______VA Investigator: ______
Title: ______
A contract with nursing service is required for all human subjects’ research in the VA Eastern Colorado Health Care System, Denver. Your contract will need to address the following elements:
1) What activities will be done by a nurse? (note: this includes activities such as assessment, surveillance, education, documentation, medication administration, phlebotomy, etc.)
2) Which of those activities will be done by study personnel and which will be performed by VA unit/clinic nursing staff?
3) Of those activities to be performed by VA unit/clinic nursing staff, you must either:
i) Document that you have verified that the study activities will not exceed the amount of the scope of care usually provided as part of standard nursing practice for this patient. Documentation includes 1.) the name of and confirmatory email from the VA nurse manager who provided the information; 2.) Name of and confirmatory email from the ACNS responsible for the unit in which the study will be implemented.
OR
ii) Describe how you will compensate or otherwise recognize the extra service provided by nursing staff.
4) For all studies, describe your plan for educating the nursing staff in the clinical area about the study (background and objectives, hypotheses, design and methods, analysis plan) and about the study protocol (what nursing staff need to know to provide safe and appropriate care for the patient).
5) For all studies, describe your plan for notifying nursing service with the names of VA patients who have been enrolled in the study.
6) For all studies, e-mail the contract and protocol/protocol summary to Judith Burke with the VA form for review and signature.
Your nursing service contact:
Sarah (Sarry) Moscatel, RN, PhD
Ext. 3010, Room 3C115, MS 118
______
VA Investigator Signature Date
Revised 1/10/13