06/18/2018: HHS has delayed the "2018 Common Rule," including implementation of the new exemption categories and review paths, until January 21, 2019.
Proposed for implementation on January 21, 2019, the current federally-defined exemption categories for human subjects research (link is external) and the U-M exemption review process will change, with:
Modification to most existing categories
Expansion in scope to several existing categories
Addition of new categories
New exempt determination processes applicable in specific circumstances:
Limited IRB review
These changes reflect the recent trends in research oversight to reduce administrative burden on investigators and IRBs for minimal-risk research.
If you have questions regarding the applicability of an exemption category to your proposed research, contact your U-M IRB for assistance prior to completing the IRB application.