The University of California, Office of the President has advised when IRB Review, Consent, Research HIPAA and the California Bill of Rights apply to clinical activities that are treated as research. The following table illustrates this advisory and practice at UCI.
|Expanded Access||Humanitarian Use||Right to Try|
|California Bill of Rights||Yes||No||Yes|
|HIPAA Research Authorization||Yes||No||No|
Please contact HRP Staff for any questions.
 REQUIRED FOR “medical experiments.” HSC 24174
 REQUIRED IF IRB has access to PHI (unusual at UCI)
 REQUIRED IF non-UCI covered components will access protected health information (PHI)