An Institutional Review Board (IRB) is the group or committee that is given the responsibility of reviewing an institution's research projects which include human study participants. The primary purpose of the IRB review is to protect the safety, rights and welfare of the participants.  The following list includes items that Fairview investigators shall consider as part of preparing the application for IRB approval.

1. Identify Study Staff: coordinator, principal and co-investigators

2. Begin thinking about contract and budget considerations
Budget and contract considerations can be completed at the same time the IRB application is being prepared and reviewed.  Budget-Contract Process

3. Complete the Education Requirement
Fairview-employed Principal Investigators, Sub-Investigators, Unaffiliated Investigators and other key personnel conducting research with Fairview patients, records, specimens, systems and resources who are involved with recruiting, consenting or data collection/abstraction need to complete the Investigator Education training once every three years and must be current upon submission of an IRB application packet to Research Administration.  The Principal Investigator has the responsibility to verify that all applicable Study Staff have completed the education requirements.  This is a federal requirement.  Training items available here
  

4. Complete Conflict of Interest Form   This is a federal requirement.  (Not required for unfunded studies)  (Available here).  

5. Complete Unaffiliated Investigator Agreement  (Required only for investigators who are not Fairview employees)  (Available here)

6. Complete IRB Application
Determine whether you are applying for a full, expedited, or exempt review.  Fairview uses the University IRB.  Check their website for instructions and forms.  UMN_IRB.  Follow all instructions carefully, include all Appendices, and get approval from all appropriate committees.  IRB accepted templates and samples are available for review:
Informed Consent Form (Link to Adult Medical & Health Study template.  Other Consent information and templates available here.)
HIPAA Authorization (Link to basic HIPAA template.  Other HIPAA information and templates available here.)

7. Send IRB application and Study documents to Research Administration  
Completed IRB applications must be reviewed for compliance with Fairview policies.  Research Administration will forward the application to the IRB for its review.
A $2000 check, payable to the University of Minnesota, required as part of the IRB application  included with study documents.

A checklist is available for your convenience Checklist