JHH Nursing Research Approval
June 2005

Guidance:

 Human research projects conducted in the Johns Hopkins Hospital that require the use of nursing time and effort must be reviewed and approved by the Director of Nursing (DON) for the involved Functional Unit(s). The PI must complete a request for Approval of Research Involving Nursing or Nursing Resources form [Request for Approval of Nursing Research], obtain the appropriate Director of Nursing (DON) signature of approval, and submit the application and protocol to Nursing Administration.  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 appropriate. Approval must be obtained in writing before initiating a protocol that involves nursing staff.  The policy and forms are available at http://www.insidehopkinsmedicine.org/nursing/nr/NURSING_RESEARCH.html or  from Nursing Administration.   This signed approval does not have to be submitted to the JHM IRB as part of the IRB application.

Note: Approaches to nursing research can take many forms.  It is important to keep several considerations in mind when planning for and seeking approval for a project. 

• 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 can assist you with linking with the appropriate individuals if needed. 
  
• This policy is intended for the conduct of research, and is not intended for clinical performance improvement activity.  

Processing Procedure:

Form: Request for Approval of Nursing Research Source: Nursing Administration

1.1 Applicant notifies the involved unit’s Manager, and /or Assistant Director and receives support for the initiative.  The Manager or Assistant Director will inform the Functional Unit Director of Nursing of the potential research project.

1.2 Applicant reviews the research plan with Functional Unit and managers, staff, or other appropriate disciplines.

1.3 Applicant completes the appropriate Johns Hopkins Medicine Institutional Review Board forms as directed by the IRB guidelines.  The Nurse Researcher or the Office of the Johns Hopkins Medicine Institutional Review Board (IRB) can be consulted related to which studies require IRB review.  The applicant, co-investigators and study team members  need to complete Human Subjects Training prior to submitting the study for IRB approval.

1.4 Applicant completes the Approval of Research Involving Nursing or Nursing Resources  (Attachment A) and attaches the research protocol, or Johns Hopkins Medicine IRB application.

1.5 Applicant reviews the research plan with the appropriate Functional Unit Director(s) of Nursing involved and obtains their approval signature(s) on the Approval of Research Involving Nursing or Nursing Resources (Attachment A).

1.6 Applicant submits completed packets to the Nurse Researcher at least one week before approval is needed by the grant deadline if the project will be submitted for funding.

1.7 The Nurse Researcher will sign off on the protocol or notify the applicant of issues that require resolution before approval.  Once the protocol is complete, the Nurse Researcher will forward it to the Director of Practice, Education, and Research for approval and signature.

1.8 The Nurse Researcher will notify the applicant by phone when all signatures are obtained.

1.9 The applicant will submit the Johns Hopkins Medicine Institutional Review Board application per IRB guidelines after completing the Nursing Research Approval Process.

1.10 The applicant may submit the protocol to outside funding sources or initiate the project after approval from the Department of Nursing and the Johns Hopkins Medicine Institutional Review Board.  Written approval must be obtained from the Department of Nursing before applying for outside funding.