Module Components

• Overview
• Assignments

Topics

• Non-Human Subject Research (NHSR)
• NHSR Application Example
• NHSR Application Process
• NHSR Determination

NDNP 811 - DNP Project Development

Module 2:HRPO Submission Process

NON-HUMAN SUBJECT RESEARCH DETERMINATION

The HRPO will communicate their determination by e-mail to the parties included on the application. If a NHSR determination is made – CONGRATULATIONS! Upload your determination letter to Assignments in Blackboard and proceed with the directions below. If the determination is not made, follow the instructions from the HRPO to revise and resubmit your application. This requires close collaboration with your Project Faculty Advisor.

Students are required to consult with the organization/agency where they are conducting their projects to determine if additional ethics or other approvals are required. It is possible that additional IRB measures beyond the NHSR determination from UMB will be required by your project site.

1. Projects within UMMC (Midtown & Downtown)
   
   Faculty project advisors, working with students, must review and submit the CICERO applications by the date indicated on the class schedule in the course syllabus. Once a UMB HRPO NHSR determination has been made, no further site approvals are needed. UMB HRPO NHSR determination meets the requirements for projects conduced at UMMC – NO further UMMC action is required.
   • Students are advised to share the determination letter with the CSR, and upload into your project SmartSheet for documentation.
2. Projects within UMMS Affiliate Institutions (Mt. Washington, BWMC, Charles Regional, Prince Georges MC/Capital Regional, UM Rehabilitation and Orthopedic Institute, UM Shore Regional, St. Joseph’s, UCH)
   
   Faculty project advisors, working with students, must review and submit the CICERO applications by the date indicated in the class schedule in the course syllabus. Once an NHSR determination has been made, students should check with the Clinical Site Representative, Unit Manager or other appropriate persons to determine if additional ethical or other approvals are required. Students should also contact the appropriate person within the organization responsible for IRB or QI related matters, provide the following information, and secure any required additional approvals:
   1. UMB HRPO Determination Letter
   2. Location of project (i.e., specific unit)
   3. DNP Project Faculty Advisor
   4. Title of DNP project
      
      
3. Projects outside UMMC or a UMMS Affiliate Institutions
   
   Faculty project advisors, working with students, must review and submit the CICERO applications by the date indicated in the class schedule in the course syllabus. Once an NHSR determination has been made, students should check with the Clinical Site Representative, Unit Manager or other appropriate persons to determine if additional ethical or other approvals are required. Students should also contact the appropriate person within the organization responsible for IRB or QI related matters, provide the following information, and secure any required additional approvals:
   
   1. UMB HRPO Determination Letter
   2. Location of project (i.e., specific unit)
   3. DNP Project Faculty Advisor
   4. Title of DNP project
      
   If the project site does not have an IRB, HRPO or a review process for QI projects, students are required to obtain signed approval from an Institution Reviewer as an agent of the organizational authorized to provide approval. The CSR is not permitted to provide approval - consider the project sponsor or an organization administrator or execute leadership. Project Faculty are required to sign the completed form
   • First verify with the Project Faculty that use of this approval procedure is appropriate for your site
   • Identify the individual at the site with the authority to provide the approval
   • Obtain a written signature on the Approval of Doctor of Nursing Practice (DNP) Project Proposal for Implementation form (the form is available in Blackboard under Assignments>Class 2) Course Information).
   • Scan to the Project Faculty for signature, and then upload into Blackboard