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Vermont

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Parents may act as a minor guardian. Individuals appointed by durable POA may consent

         

Age of Consent: 18-No exceptions

         

Informed Consent Requirements: Comply w/ Fed. Regulations

         

IRB Requirements: Comply w/ Fed. Regulations

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: PI's who treat subjects w/ STD's shall report such treatment along w/ name, race, martial status, address, age, & gender along w/ date & source of STD (See VSA 1091, 92, & 1101)

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: Must be labeled "For Investigational Use Only". PI or authorized clinician(s) may administer

 

Genetic Testing: Written ICF is required before testing or disclosure, PHI is not disclosed or is coded. Violations for Non-compliance

 

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: VT has in place requirements that are implemented through regulation rather than legislation

         

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.leg.state.vt.us/statutes/statutes2.htm 

 

 

Last Updated ( Wednesday, 16 September 2015 14:35 )