On January 17, 2018, it was announced that the scheduled revision to the Common Rule has been delayed (view the public notice of delay here). Given this news, the Harvard IRBs will continue to apply the existing federal regulations to all human research until the new Final Rule implementation date is confirmed. To find out more, please visit your IRB website:
- Longwood Medical Area: https://www.hsph.harvard.edu/ohra/final-rule/
- University Area: https://cuhs.harvard.edu/news/breaking-news...
NOTICE! As part of this change, along with some other needed fixes, ESTR was udated on Thursday, January 25. Please view the detailed relese notes to see what was included in this update. Two items of note:
- The "type of study" selection on the Basic Information page of the SmartForm can be edited during clarifications requested or modification (up until a Site submission is created).
- IRB documents (such as consent and protocol templates) have been revised.
Please note that revised guidance materials will be updated leading up to Janaury 25.