The Exemption review procedure is applicable only for activities that fit the federal categories, which are listed on the Exemption Review Application. Questions of interpretation regarding the exemption application may be directed to the OIRB at 934-3789.
Any modifications to the protocol require IRB review to assure the modifications do not change the exempt status of the protocol.
Only the IRB can assign Exempt status.
Federal regulations specify that the following research activities cannot be exempt:
OHRP has published decision trees to help in determining whether a research proposal fits the criteria for Exempt, Expedited, or Full review. The charts are available at http://www.hhs.gov/ohrp/policy/checklists/index.html to help investigators determine whether their proposed research may be eligible for exemption.
There are no deadlines for submission of an Application for Exemption Review.
Page updated: May 8, 2013