New human subject regulations will go into effect

On Jan. 21, 2019, new regulations governing the conduct of research with human participants will go into effect.

The Institutional Review Board (IRB) is getting ready by working on new application forms and templates, and modifying policies and procedures.

In order to ensure a smooth transition, we will be implementing a freeze on all new protocol submissions between Jan. 12-21, 2019. During this time, the IRB will not be accepting any new protocols for review.

Researchers may still submit amendments and annual reviews for existing research; however, no submissions for new research protocols will be accepted. Because both the effective date and the compliance date for the new regulations are January 21, 2019, there is no grace period allowing the IRB to easily transition new submissions from the old to new rules. This is the reason for the freeze on new submissions – to ensure no protocols are caught in limbo between the old and new regulations. Beginning Jan. 22, 2019, the IRB forms section will include new application forms and consent templates, and researchers may begin submitting new protocols for review.

For researchers with protocols that are approved before Jan. 21, 2019, these studies will remain under the current regulations. They will not be expected to transition to the new regulations, and researchers should experience no disruption to their approved research activities.

Thank you in advance for your patience and understanding as we work to implement the new regulations.