Kuali Research Protocols (KRP): Administrative Determination vs a Protocol for IRB Review

  • There are 3 types of applications in KRP 
  • Keep this reference on hand when navigating human subject research at UCI.
one

Non-Human Subjects Research (NHSR) Self-Determination

two

Exempt Self-Determination

UCI allows Exempt Self-Determination for Categories 1-4ii.

There are exceptions for certain populations and procedures.

three

Exempt Research that
Requires IRB Approval

Exempt research that is not eligible for Self-Determination or that requires limited IRB review, must be submitted for UCI IRB review and approval.

NOT Human Subject Research

Human Subject Research

UCI IRB Review is NOT Required

UCI IRB Review Required

 

Administrative Determination Submission Required

 

 

Existing self-determinations completed prior to the launch of KRP (September 2021) remain valid.  Do not re-submit in KRP.

Activities may begin once the self-determination form is completed and submitted. The UCI IRB will not review or approve the submission.

If sponsor requires evidence of NHSR,
print the Administrative Determination Submission
from KRP and provide this documentation to the sponsor.

The Education and Quality Improvement Program (EQUIP) will conduct routine quality assurance review of the submissions
to ensure accuracy of the self-determinations.

Amendments are not necessary unless activity no longer qualifies for the self-determination. In that case, amend the submission in KRP to allow for IRB review OR submit a new study in KRP.

Activities may begin once UCI IRB Approval has been granted.

EQUIP will conduct routine
quality assurance reviews of IRB approved protocols.

Minor changes to exempt research do NOT require an amendment. Significant changes to exempt research require UCI IRB review and approval. See HRP website: Protocol Amendments