16. I submitted my study before January 21, 2019 but it has not been approved. Will the revised Common Rule apply and how will I know?

15. How will I know if the revised Common Rule applies to my study?

The revised Common Rule will apply to all studies with an approval date (not submission date) on or after January 21, 2019. The approval date is listed on your IRB approval letter.

14. My study was approved before January 21, 2019. Will the revised Common Rule affect my study?

No. The revised Common Rule will not apply to studies approved before January 21, 2019. Please note there will be no transition to the requirements of the revised Common Rule for studies approved before January 21, 2019.

13. I would like to learn more about the revised Common Rule. Are there any trainings/resources that are available?

“Revised Common Rule” module is available through CITI that can help you understand the general provisions (non-UMass specific) of the revised Common Rule. Once you log in to your CITI account, click “View Courses” and the Revised Common Rule Course will be listed. This course is OPTIONAL and does not satisfy the requirements for human subjects training.

OHRP has also developed educational materials and a list of frequently asked questions.

12. Do I need to update my human subjects CITI training once the revised Common Rule comes into effect?

No. You do not need to update your human subjects CITI training once the revised Common Rule comes into effect. However, there is a training module available through CITI that can help you understand the general provisions (non-UMass specific) of the revised Common Rule. The training module is called “Revised Common Rule”.

11. Where can I find the update consent templates that are in compliance with the revised Common Rule?

Updated consent templates can be found at https://www.umass.edu/research/compliance/human-subjects-irb/forms.

10. My study was approved before January 21, 2019. Do I need to submit a revised consent document?

No. Your study will continue to fall under the pre-revised Common Rule provisions thus no consent document changes will be necessary.

9. I’m planning to submit a revision to my study. Are there any changes I should be aware of under the revised Common Rule?

Your study will continue to fall under the pre-revised Common Rule provisions thus no changes (for example, updates to consent, continuing review procedures, etc.) will be applicable.

8. My study was approved under the Expedited category, but with the revised Common Rule now fits into the Exempt category. Should I submit a revision to update the review category?

No. UMass IRB/HRPO reviews all exempt protocols as well and thus a review category re-assignment will not make any difference to the IRB protocol review process. Please note there will be no transition to the requirements of the revised Common Rule for studies approved before January 21, 2019.

7. My study was approved on or after January 21, 2019. How would I know if I need to submit a renewal in the coming year?

Your IRB approval letter will indicate the designation as requiring or not requiring a continuing review/renewal. Continuing review will no longer be required as a general practice unless the IRB reviewer explicitly justifies why continuing review would enhance protection of human research subjects. UMASS IRB/HRPO will notify the researcher if continuing review is required for their study.

Human Subjects