Revisions to the Common Rule - II
The January 21 2019 compliance date is fast approaching!
Here's information we've gleaned so far from guidance from the Office of Human Research Protections:
1) all non-exempt (expedited) protocols approved by the IRB before 1/21/19 will continue to follow pre-2018 provisions. This means continuing as normal, including continuing renewal of annual reports through the term of the approved projects. Currently enrolled participants will not need to be re-consented with a revised (2018 version) consent version.
2) new participants enrolled in current protocols continuing after 1/21/19 will need to be consented using the revised consent document format.
3) current exempt approved protocols will follow the above steps as well.
4) exempt and expedited protocols submitted on or after 1/21/19 will follow the new application forms and procedures.
The ORPC will be in contact the PIs by early next week informing them of the above.
The IRB webpages are continuing to be updated. These updated pages will be posted to the IRB website (as well as updates to application forms and consent templates) during the Jan 19-20 weekend.
Posted: January 10, 2019, 9:16 PM