Implementation and Transition to the New Rule

 

Implementation for New Studies

Exempt Studies: Effective January 21, 2019, exemptions will be accepted on the new forms and will be processed under the Revised Rule.

New Expedited and Full Board studies approved after January 21, 2019 will need to be in compliance with the Revised Rule.  This includes protocols that are submitted to HRPO prior to January 21, 2019 but processed on or after that date.  

 

Existing Studies

Studies approved prior to January 21, 2019 will continue to comply with the Pre-2018 Rule.  Compliance with the Pre-2018 Rule does not preclude the IRB from requesting changes or study teams from voluntarily modifying to add key information and relevant sharing/additional language to the consent forms as this language is not prohibited by the Pre-2018 Rule.  If a study team wishes to modify the study to include additional language, a modification would need to be submitted and approved prior to the implementation of the changes.

Existing federally funded studies in compliance with the Pre-2018 Rule cannot be released from continuing review and must continue to be submitted annually for review, per the regulations.