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Institutional Review Board

Human Research Protections (HRP)

 

Program Update:

Removal of Exempt 4iii


Version August 28, 2020

 

The 2018 Common Rule went into effect on January 21, 2019, specifying revised exempt research categories under 45 CFR 46. 104.  One of the revised categories, Exempt 4iii allows for the secondary use of existing and prospective health data. 

 

This summer, the UC Office of the President (UCOP) Counsel released guidance about the impact of HIPAA on Exempt 4iii. Namely, UCOP has stated that Exempt 4iii does not apply to activities outside of the Covered Entity’s use of the PHI. 

 

Effective immediately UCI will no longer use Exempt 4iii.

The UCI IRB Application now reflects this change.

Look for updates to the UCI IRB Protocol Narratives to reflect the above- coming soon!

Additional Background Information:

The University of California is a hybrid entity with a Single Health Care Component

(SHCC) that performs multiple functions covered by HIPAA.  Research is not part of UC’s Covered Entity.  This means that once PHI is disclosed by the SHCC to the researcher under either a signed authorization or a waiver of authorization, any research use of the identifiable private information is no longer protected under the Privacy Rule.  Under these circumstances, the exempt 4(iii) category is not appropriate for federally supported research. To streamline, the UCI HRP has opted to remove the allowance of exempt 4iii – even for non-federally supported research.  This decision recognizes that expedited category 5 is a comparable category that would afford researchers the same 3 year approval period as the 3-year exempt confirmation.

For more information, visit the HRP Webpage: Levels of Review, subsection, Exempt Research.