Changes to the Exempt Categories

Changes to the Exempt Categories

Summary of Changes

  • [Revised] Exempt Category 2(iii) has now been expanded to allow collection of potentially sensitive or harmful identifiable private information from adults if an IRB conducts a limited review* and determines that there are adequate provisions for protecting privacy and maintaining confidentiality

*The revised Common Rule allows for the exemption of research collecting identifiable information with the potential to cause harm if disclosed, provided that the IRB has determined that “there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data”. This new requirement is called a limited IRB review.

  • [New] Exempt Category 3 "Benign behavioral interventions*" such as solving puzzles or playing online games. Can also collect sensitive information with a limited IRB review

      *Benign behavioral interventions are defined as “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing”.  Excludes physiological data collection methods (e.g., EEG, wearable devices such as FitBitTM, accelerometers, eye-tracking devices, blood pressure monitors, etc.)

  • [Revised] Exempt Category 4 (medical record review) can now be prospective as well
  • [New] Exempt categories 7 & 8 include limited reviews and Broad Consent.

Studies approved PRIOR to January 21, 2019

  • Impact on Researchers: NONE
  • UMass IRB/HRPO will continue to review all exempt protocols.
    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 fro persons, beneficence, and justice. Researchers must also comply with all applicable state and local regulations.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: NONE
  • The UMass IRB/HRPO will evaluate each submission and manually assign the applicable Exempt categories per the revised Common Rule. Meanwhile, the researchers should continue to select from the pre-2019 Exempt categories as listed in Kuali.

NOTES:

Please do NOT submit revisions to protocols reviewed under the "Expedited" categories to change the review category to "Exempt".

UMass IRB/HRPO reviews all exempt protocols and thus a review category re-assignment will not make any difference to the IRB protocol review process.

At this time UMass Amherst will not implement new Exempt categories 7 & 8 due to a possible increase in researcher's burden to track and store broad consents. This may change after additional guidance is provided by OHRP.