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Human research studies conducted at The Johns Hopkins Hospital that require the use of nursing time and effort that are incremental to the usual or routine standard of care, shall be reviewed and approved by the Director of Nursing (DON) for the involved Functional Unit(s). The Principal Investigator (PI) shall complete a request for Approval of Research Involving Nursing or Nursing Resources form and obtain the appropriate DON signature of approval. If more than one Functional Unit is included in the study, each DON will need to approve.
The DON will assess and determine if and how nurses' participation may impact the delivery of safe and appropriate care. This assessment will include a dialogue with the PI, and any involved managers, staff, or other disciplines as appropriate. Approval must be obtained in writing before initiating a protocol that involves nursing staff.
Forward the completed application with the DON(s) signature(s) and a protocol summary to the Nurse Researcher, Billings Administration 220.
The Department of Nursing Nurse Researcher will sign off on the protocol or notify the applicant of issues that require resolution before approval. Once the application is completed, the Nurse Researcher will forward it to the Director of Nursing, Practice, Education, & Research for final approval and signature.
The Nurse Researcher will notify the applicant by phone or email when all signatures are obtained (allow one week).This signed approval does not have to be submitted to the JHM IRB as part of the IRB application.
Note: It is important to keep several considerations in mind when planning for and seeking approval for a research study.
- Contact the key individuals in the approval process early in the planning of the project to develop a realistic time frame.
- Various research consultants are available within the Hospital and the University. The Nurse Researcher (410-614-2805) can assist you with referrals to the appropriate individuals if needed.
- This policy is intended for the conduct of research, and is not intended for clinical performance improvement activity.