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Hawaii

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

http://www.capitol.hawaii.gov/site1/hrs/default.asp

 

 

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