On January 21, 2019, a number of changes to the Federal Policy for the Protection of Human Subjects (aka the Common Rule) are scheduled to take effect.
For studies already approved or certified as exempt before January 21, 2019:
These studies remain under the pre-2018 regulations. Neither you nor the IRB need to do anything new to these studies at this time. Please continue to submit amendments, continuing reviews, problem/event reports and study closures as usual.
For federally funded studies receiving initial IRB approval or exemption after January 21, 2019:
There are three key areas of change:
Consent content is the only area that might involve some minor near-term work for PIs and their teams. Please see the companion announcement about consent for more information.
The HRPP is currently overhauling how it handles minimal risk research. As part of this overhaul, the HRPP will apply the flexibilities related to continuing review and to exemption whenever possible.
Please note that even if a study does not need continuing review, PIs are still responsible for submitting amendments, problem/event reports and study closures as usual.
For non-federally funded studies receiving initial IRB approval or exemption after January 21, 2019:
No new action is required on your part for these studies. The IRBs and the HRPP will not apply the new informed consent requirements to these studies. The HRPP will apply flexibilities related to continuing review and to exemption as described above.
Other important information includes the following:
Federal agencies have issued minimal guidance to date, so these rule changes are likely to evolve over the coming months. HRPP will make clarifying announcements as needed.
The Food and Drug Administration (FDA) and the Department of Justice (DOJ) have not harmonized their regulations with the Revised Common Rule. FDA-regulated or DOJ-funded studies are not yet eligible for flexibilities allowed by the Revised Common Rule (for example, FDA regulated studies still require Continuing Review at least annually regardless of the level of risk).
The Revised Common Rule also includes the following:
These other changes do not have any practical effect on your research at this time. HRPP will make additional announcements about these changes as appropriate.
In the Summer of 2019, the HRPP expects to be able to offer opportunities to convert existing studies to the new rules if advantageous to you (for example, to eliminate continuing review).