Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.
State Legal Structure: Comply w/ Fed. Regulations
Required Notification to State Officials: None Specified
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Guardians of either minors or incapacitated persons and persons holding POA or who are appointed under advanced health care may act as legal reps
Age of Consent: 18-Married minors may consent
Informed Consent Requirements: Comply w/ Fed. Regulations
IRB Requirements: Comply w/ Fed. Regulations
Special Rules for Cancer Research: None Specified
HIV/AIDS Testing: See H.R.S. 325.16; 325-101; 325-2 ICF is required prior to HIV testing, unless the subject remains anonymous to the PI. Counseling must be available.
Payments to Subjects: Health intervention must be covered by a health insurance plan if it is medically necessary
Drug Supply Requirements: None Specified
Genetic Testing: ICF is required to disclose any genetic information.
Cancer Insurance Section
Mandates for Coverage of CT Trials & Insurer: None Specified
Phases Covered: None Specified
Organization Approved to Conduct: None Specified
Specific Conditions of CT Coverage: None Specified
Mandates for Coverage of Off-Label Rx: None Specified
Medically Necessary Services: None Specified
Experimental or Contraindicated Rx NOT Covered: None Specified
Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified
State Codes & Links:
All codes can be found at