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West Virginia

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: The following may consent on behalf of a child or adult who is incapable:1.parent 2.Spouse 3.adult Child 4.adult parents 5. Adult sibling 6. Grandparent or adult grandchild 7.Close friend 8.Person appointed by court

 

Age of Consent: 18-or emancipated minors, or if PI is authorized to determine whether or not a minor is capable of understanding

         

Informed Consent Requirements: Comply w/ Fed. Regulations, must be written ICF

         

IRB Requirements: Comply w/ Fed. Regulations

         

Special Rules for Cancer Research: Insurance requirements only, see insurance section

         

HIV/AIDS Testing: Written ICF is NOT required if no PHI is being gathered. Counseling must be available.

 

Payments to Subjects: Insurance requirements only, see insurance section.

         

Drug Supply Requirements: None Specified

 

Genetic Testing: None Specified

 

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: None Specified

         

Phases Covered: Phases II, III, & IV ONLY

         

Organization Approved to Conduct: FDA, NIH, & VA. NCI & DOD are NOT included

         

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.legis.state.wv.us/WVCODE/Code.cfm

 

 

 

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