Common Rule Announcement
The Federal Office for Human Research Protection has substantially revised the IRB regulations, known as the “Common Rule.” The effective date for the revised Common Rule is January 21, 2019. The revisions include:
- Substantive changes to the exempt research categories and the exempt review process.
- New elements of consent (The NYU IRB incorporated most of these elements into its consent form template that took effect last year).
- Most expedited studies will not require continuing/annual review.
Because of these revisions, there are new training requirements for all NYU Washington Square investigators. Please see the NYU IRB Training page for directions on completing this training, which must be completed by January 21, 2019. This training will be verified by the IRB during review of initial submissions, renewals, and modifications to studies that are under the new rule.
The Cayuse IRB Initial submission forms will be changed to reflect the revised Common Rule.
- All Initial submissions created before January 7 will fall under the old Common Rule and must be submitted before January 11, so they are reviewed before January 21.
- Initial submissions created before January 7 and submitted after January 11 will be required to create and submit a new Initial submission that is compliant with the revised common rule.
- Initial submission forms will be updated on January 7 to reflect the revised Common Rule. All Initial submissions created on or after January 7 will be reviewed under the revised Common Rule on or after January 21.