Human Subjects FAQ

The revised Common Rule comes into effect on January 21, 2019.

If you are unsure whether your activities need a review by the IRB or not please complete a Determination Form that is available here. The completed form should be submitted to the Human Research Protection Office at humansubjects@ora.umass.edu.

Yes. UMass IRB/HRPO reviews all exempt protocols so a submission is required.

A determination of "exempt" means the proposed research activity meets one of the exemption criteria and thus is exempt from the federal regulations that govern the conduct of human subjects research, Common Rule (45 CFR 46).  However, a research activity determined as “Exempt”, must still be reviewed by the IRB and conducted in accordance with the ethical principles outlined in the Belmont Report: respect for persons, beneficence, and justice. Researchers must also comply with all applicable state and local regulations.

 

If your study was approved before January 21, 2019, there will be no changes.  For Full Board studies approved on or after January 21, 2019 the requirements of the revised Common Rule will be applicable.  We will communicate via comments during the protocol review process and guide you in complying with the revised Common Rule based upon your specific research protocol and methods.

We do not expect significant delays in the IRB review process.  Keeping in mind the IRB’s normal processing time of 4-6 weeks prior to approval, it is likely that for studies submitted on or after January 1, 2019 the revised Common Rule will apply.

Yes. All studies that have been approved before January 21, 2019 will continue to require annual renewals until the study is completed at which time a final report form must be filed.

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.

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.

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.

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

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”.

“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.

https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html

https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html#transition-provision

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.

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.

The revised Common Rule will only apply if your study is approved on or after January 21, 2019.  Applicability of the revised Common Rule is not based on the study submission date.  If our IRB reviewers believe your study is not likely to be approved prior to January 21, 2019, we will communicate via comments during the protocol review process and ask you to update your consent(s) to comply with the revised Common Rule.  In addition, if applicable, our staff will automatically re-assign the review category (Exempt --> Expedited or Expedited --> Exempt) under the provisions of the revised Common Rule.

Please contact the Human Research Protection Office at 545-3428 or humansubjects@ora.umass.edu.