COMIRB has posted two new decision tools to assist investigators in determining if their study requires an Investigational Device Exemption (IDE) or Investigational New Drug (IND) application.
InfoEd no longer automatically sends emails reminding study personnel on COMIRB-approved protocols to recertify their human subjects training through CITI when their certification is close to expiring.
Starting July 1, 2019, COMIRB will require that the Secondary Research Application be used for secondary research submissions, for improved consistency and clarity.
COMIRB has revised its Short Form to comply with the "Key Information" requirements of the 2018 Federal Policy on the Protection of Human Subjects ("Common Rule").
The 2018 Requirements for human subjects protections go into effect (finally!) on January 21, 2018. COMIRB will host a town hall to discuss changes we have made to comply with the new requirements.