Changes in Exemption Research Categories

Effective January 21, 2019 current federal exemption categories for human subject research will change with:

• Addition of new categories
• Modification to most existing categories
• Expansion of the scope to several existing categories
• New exempt determination process of Limited IRB review

A comparison of the old and new exemption categories is available here.

MHC Transition and Implementation Process

• For Existing Exempt Protocols - All studies determined to be exempt prior to 1/21/19 will continue as under the current Rule. No further review is required unless a modification is made which may change the exempt status. As a reminder, if you have an exempt study that has ended, it is important to close the study with the IRB.
• For Future Exempt Protocols* –
• Limited IRB review – Is a type of expedited review process required in the Common Rule. Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection or use of sensitive and identifiable data. For those exemption categories adopted at our institution, limited IRB review means that only the approval criterion dealing with privacy and confidentiality needs to be met. This would need to be confirmed by an IRB Chair or member and can be conducted by expedited review.
• New studies submitted for an exempt determination after January 21, 2019 will utilize the new eProtocol application type. The Revised Common Rule will apply to these studies.