Allina Health IRB Submissions

What must be submitted to Quorum Review IRB?

Studies to Submit to Quorum
Submit Industry-sponsored research that requires full board review to Quorum Review IRB.

How do I submit studies to Quorum Review IRB?

Initial Submissions

• Step 1: Access the appropriate Quorum Review IRB submission forms.

• Step 2: Complete Quorum Review IRB submission forms, including the Allina Health- Quorum Institution Cover Page and the Allina Health Study Personnel Roster.

• Step 3: Submit the following forms to the Allina Health IRB staff at :

ü Allina Health-Quorum Institution Cover Page

ü Allina Health Study Personnel Roster

ü Study-Specific HIPAA Authorization (Researchers are required to use Allina

Health’s HIPAA Authorization Template.)

ü Allina Health – Required Consent form Elements (Researchers must include the following Consent Form Elements.)

ü SPA approval email

ü Conflict of Interest information, if applicable

• Step 4: IRB staff will review the Allina-specific forms, sign the Institution Cover Page, and return a scanned copy to you.

IRB staff will review the submissions on the following points:

ü Are the researchers’ educational certifications current?

Allina Health’s Institutional Review Boards require training for research personnel in the protection of human research subjects. Documentation of this training is required before any new study will be approved by the IRB and for all ongoing studies at the time of continuing review. Please see the Training Information Sheet for the IRB's requirements regarding researcher training.

ü Do any of the researchers on the study have a significant financial interest in the sponsoring company?

• Step 5: Submit the appropriate forms to Quorum Review IRB.

Respond to requests for additional information from Quorum Review IRB to secure approval.

Maintaining Approval and Ongoing Submissions

Once the initial submission is approved, the Principal Investigator is responsible for submitting all necessary forms to Quorum Review IRB including the following:

• Changes in Research (Amendments)

• Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs)

• Continuing Reviews

• Study Closures