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How Do I Submit Items for IRB Review?


New Studies

Before a research study involving human subjects can begin, the IRB must review and approve it. To submit an application for review, please consult the instructions on the IRB/SPA Submission System (eProtocol) page. Note that, to gain access to the system, you must first sign and submit a user agreement. (Instructions for submitting the user agreement appear at the end of the form.)

In addition, Allina Health’s Institutional Review Boards require training for research personnel in the protection of human research subjects. The IRB must receive documentation of this training before it will approve a new study or an ongoing study at the time of continuing review. Please see the Training Information Sheet for the IRB's requirements regarding researcher training.

HIPAA Submission Requirements

Investigators must follow state and federal regulations regarding the use and disclosure of Protected Health Information for research purposes. The following links to guidance regarding what is required to be submitted and why:

Instructions for Submitting Post-Approval Forms

After the IRB has approved the research study or project, it is the investigator's responsibility to report the following:

Study Closures

When a study has been completed or terminated, investigators should submit a Final Report Form (accessed through eProtocol) to close their studies. A study is ready to be closed if the answer to all the following questions is "Yes":

  • Have you submitted all required reports to the IRB? (Note that once you open a Final Report Form in eProtocol, you will be unable to open any other forms.)
  • Have all the subjects completed all research-related interventions?
  • Have all the subjects completed all research-related follow-up?
  • Have you completed all data analysis?
  • Has your sponsored project (funding) been closed?

IRB Review Process Flowcharts

These flowcharts walk you through the review process for each of the following:


 

 

IRB Administrative Office

Mailing Address:
Mail Route 10105
PO Box 43
Minneapolis, MN 55440-0043

Phone: 612-262-4920
Fax: 612-262-4953

Office Location:
Allina Commons at Midtown Exchange
Mail Route 10105
2925 Chicago Avenue
Minneapolis, MN 55407-1321