Changes with myIRB and HRPO Processes

Exempt Application Form

The myIRB Exempt application has been revised to improve the efficiency of the IRB submission and review process.  Questions that are not necessary to document eligibility for exempt review have been removed.

Many of the items that were eliminated or edited pertain to biomedical interventional research, which is not eligible for exempt review, for example- clinical trials and studies involving FDA regulated products (with the exception of “Taste and food quality evaluation and consumer acceptance studies.”).

When the revised Exempt Application Form is released, it will also include a new Exempt Information Sheet that includes required language for studies that are subject to any of the following:

  • Health Insurance Portability and Accountability Act (HIPAA)
  • Family Educational Rights and Privacy Act (FERPA)
  • European General Data Protection Regulation (GDPR)

All other consent templates have been removed from the Exempt Application Form because they contain elements that are not required for research eligible for exempt review.  However, researchers may include additional information in the information sheet, if so desired.

Exempt review is limited to human subjects research that fits into one of the exempt categories outlined in the Code of Federal Regulations at 45 CFR 46.104.

 

Stamping Recruitment Materials

The Human Research Protection Office will no longer stamp IRB approved recruitment materials.

Starting 7/1/2022, research teams will no longer be able to upload recruitment materials to myIRB that include the electronic myIRB stamp. Research teams attempting to upload stamped recruitment materials will receive an error message in myIRB.

This will impact all studies regardless of approval status including: draft forms, pending forms, and modifications to existing studies.

The IRB approval stamp will continue to be present and function (changing approval dates at the time of continuing review) for recruitment materials uploaded prior to 7/1/2022. Click here for the myIRB FAQ on editing materials previously stamped.

A memo is available for research teams to include in their regulatory binder. This memo documents the change in IRB practice.

The IRB stamp will still be required for consent materials.