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HSRC Forms
Follow these steps to select the correct forms.

Step 1:






Use this form to determine which type of research review to request. If you believe your project does not involve human subjects, their records, or data in any way, you may call the Center for Research (734-432-5666) to discuss it with the Director or HSRC Chair to determine if an application is needed.

Submit completed form with your application to the Center for Research.
  •  Checklist for Type of Research Review

Step 2: Complete Appropriate Application Form.
               •  Application A: Exempt Review Request
               •  Application B: Expedited or Full Review Request
               •  Application C: TET or FPD Review Request
               •  Application D: Semester Only Project Review Request 
               •  Application E: Umbrella Application for Exemption (Instructor's form)

Step 3: Complete Appropriate Appendices indicated in the Application form (Step 2).
               Guidance Documents
               •  HIPPAA Rules
               •  HIPPAA Identifiers
               •  Guidance for Consent – Exempt
               •  Consent templates
                -  Exempt
                -  Expedited or Full
 
               Appendices

               •  Appendix A: Agency Permission
               •  Appendix B: HIPPAA Waiver
               •  Appendix C: Deception
               •  Appendix D1: Waiver or Alteration of Consent Process
               •  Appendix D2: Waiver of Consent Documentation
               •  Appendix E: Decisionally Impaired
               •  Appendix F: Pregnant Women & Neonates
               •  Appendix G: Non-English Speaking Participants
               •  Appendix H: Children

Step 4: Obtain required signatures and approvals.

Step 5: Follow instructions on first page of Application for bundling and naming documents.

Step 6: Submit Completed Application with all documents to CenterForResearch@madonna.edu.

Additional Forms
These forms may be used when the investigator needs IRB review at two or more institutions.  All human subject research done at Madonna University must be reviewed/approved by MU Human Subjects Review Committee (HSRC) through initial review using forms above (for MU students and faculty) or agreement using forms below.
MU IRB of Record Authorization Agreement (used when MU approves proposal but research is to be conducted at another institution with OHRP-approved IRB with FWA)
External IRB of Record Collaboration Agreement (used when investigators from two or more institutions with OHRP-approved IRB with FWA, including MU, are involved)
External IRB of Record Authorization Agreement (used when proposal approved by another OHRP-approved IRB with FWA but research is to be conducted at MU)

HSRC approval expires after one year. Use this form to reapply and extend approval. (Investigators with research given an exempt approval are not required to resubmit.)
•  Application for Renewal of HSRC approval

Research Integrity and Misconduct
•  Report of Research Misconduct



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