What do I need to demonstrate to request a waiver of documentation of consent?

The IRB provides a consent alteration or waiver request form on the IRB website to walk you through the requirements.  The form is located on the IRB Forms – other forms tab.  It is titled Informed Consent or Authorization Waiver Request.

The required elements are:

1. The research involves no more than minimal risk to the subjects.
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
3. The research could not practicably be carried out without the waiver or alteration (i.e., it would not be possible to do this research with active signed parent/guardian permission)
4. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
5. If the research involves using identifiable private information or identifiable biospecimens, the research could not be carried out without using such information or biospecimens in an identifiable format (i.e., it would not be possible to do this research without obtaining identifiable information and/or biospecimens)  This would require an explanation of how you will protect that data and destroy identifiers at the earliest possible time.
6. Subject selection should be based upon class or group membership or open enrollment and not exclusionary unless the investigator can depend solely upon exclusion criteria documented in the consent language for subject self-selection.

Last updated: 8/31/2023