E & I Disclaimer Statement for this Website

Last modified March 2, 2009.

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




Last Updated ( Wednesday, 16 September 2015 14:45 )