Effective January 21, 2019, human subjects research is subject to revised regulations. *Please note that FDA has not yet harmonized, so parts of the new Rule cannot be applied to FDA-regulated research.* Details are available in our recent webinars here: http://irb.emory.edu/Training/webinars.html.
What will you see in eIRB? If you submit, or edit a new submission, after January 1, you will see indications that it is under the “2018” rule (confusingly named, due to multiple federal delays). This is because the new rule applies to studies approved on or after January 21. The January 1 transition date date anticipates at least a 3 week IRB review time. Feel free to hold off on submission until after January 1, in order to automatically come under the new Rule.
Since eIRB cannot tell if a study is FDA-regulated, all new studies will come in under the new Rule. IRB staff will then manually revert FDA-regulated studies back to the old “pre-2018” Rule during intake screening.
Most important for you:
- The new Rule requires additional consent form elements
- Includes a whole new introductory section for a “concise summary of key information” (to prevent the important facts being lost in long consent forms).
- We will post revised templates shortly (though federal guidance on the elements is not yet available).
- The new intro summary is necessary for federally funded studies, though you can adopt for all studies if desired.
- Minimal risk studies will no longer have expiration dates (unless FDA-regulated). You must still submit amendments, reportable events, and close-outs as before (eIRB will be sending annual reminders about this).
- Changes to Exemption categories: Some studies that were “expedited” in the past may be given Exemption instead (there is little difference from researcher perspective)
- Ongoing studies approved prior to January 21 will remain under the old Rule – i.e. will still have expiration dates and require continuing review – unless they are transitioned to the new Rule.
- We will let you know if we plan to transition your study over the next year; some actions may be required on your part as part of the transition.