Institutional Review Board (IRB) Human Research Protections (HRP)
HIPAA & Consent Waivers Streamlined
Version February 22, 2024
The HIPAA and consent waiver sections of the IRB application have been streamlined.
This change will only impact new studies submitted to the IRB after February 21, 2024.
HIPAA waiver section was reduced from 14 questions/prompts to 3-5
Consent waiver section was reduced from 9 questions/prompts to 2-3
Sections were trimmed down to focus on the regulatory criteria, without extraneous prompts
Justification for each regulatory criterion is no longer required; rather, most criteria have been collapsed together into a single check-box prompt to confirm its applicability
The prompt addressing the practicability criterion has been revised to include a list of predefined justifications that the IRB finds acceptable. Researchers may select from the list or provide their own free response justification.
Benefits:
Reduces administrative burden for researchers and HRP colleagues
Reduces researcher error rate when addressing regulatory criteria for waivers
Improves time to approval for minimal risk research that is limited to the review of private identifiable records (i.e., medical or school records)
Any questions or comments? Please feel free to reach out to HRP Staff directly Stay informed!
