On January 21, 2019, revisions to the federal regulations overseeing human subject research went into effect (known as the revised Common Rule).
The new Common Rule broadens the types of research that may fall under the Exempt Category of review (45 CFR 46.104). For example, starting January 21, 2019 some benign behavioral interventions with adults may be eligible for exemption.
NU will not implement Exemptions #7 and #8 at this time.
For information about how to submit an Exempt Self-Determination Form, please click here.
Some expedited studies approved on or after January 21, 2019 may no longer be required to undergo continuing review and have their approval renewed on an annual basis (45 CFR 46.109(f)(1)(i)). At the time of initial approval, researchers will be informed about whether or not a determination for continuing review has been made.
Even when continuing review is not required, investigators remain responsible for updating the IRB about adverse events and other unanticipated problems, seeking IRB approval for changes to personnel, protocol amendments, recruitment materials, etc., and informing the IRB when the research is complete.
All consent forms are now required to start with “a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.” Please note that “Key Information” will vary from study to study. (45 CFR 46.116)
Consent forms will also need to include information regarding the potential for future use of de-identified data and biospecimens.
Northeastern University consent form templates have been updated to reflect these new elements.
Starting on January 19, 2020, there will be a new requirement that cooperative research studies involving more than one institution to use a single IRB for review.
The revised Common Rule will apply to any research project approved on or after Jan. 21, 2019.
Research studies approved via expedited review prior to January 21, 2019 will continue to be governed by the and governed by the Pre-2018 Rule. The NU IRB is not planning to transition any projects unless a researcher requests it and it is determined to be in the best interest of the subjects.