Tag: Common Rule
-
OHRP Exceptions to Single IRB Review
On November 22, 2019, OHRP announced that federally-funded multisite studies with IRB approval before 1/20/20, do not need to move to single IRB review, per the revised Common Rule. OHRP made this announcement after receiving feedback from institutions pointing out that transitioning ongoing studies from local IRBs to a single IRB would result in unnecessary…
-
Common Rule Delay and Single IRB Requirement for Federally Supported Studies
On January 17, 2018, changes to the common rule that were scheduled to be effective on January 19, 2018, were delayed 6 months. The new effective and compliance date is July 19, 2018. This will allow time for the regulatory agencies to develop more guidance around the 2018 Common Rule, and they will also work…
-
The Common Rule is Revised – but under temporary moratorium
DHHS’s revised “Common Rule” governing human subjects research was finally published, and will become effective January 19, 2018 (except for the single-IRB requirement for cooperative research, which is two years later). However, there is a 60 day moratorium in effect at the moment. For summaries of the very significant changes (including removal of continuing review…