Clinical Activities as Research: When IRB Review, Consent, Research HIPAA and California Bill of Rights Apply

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 AccessHumanitarian UseRight to Try
IRB Review YesYesYes
Consent RequiredYesYesYes
California Bill of Rights[1]YesNo Yes
HIPAA Research AuthorizationYesNo[2]No[3]

Please contact HRP Staff for any questions.

[1] REQUIRED FOR “medical experiments.” HSC 24174

[2] REQUIRED IF IRB has access to PHI (unusual at UCI)

[3] REQUIRED IF non-UCI covered components will access protected health information (PHI)

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