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Nevada

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Mental Health Subjects in a Mental health facility must obtain written ICF from the subject if competent, guardian, and parent if under 18.

         

Age of Consent: 18-or emancipated minors

         

Informed Consent Requirements: Comply w/ Fed. Regulations.

         

IRB Requirements: Comply w/ Fed. Regulations.

         

Special Rules for Cancer Research: No available treatment is considered superior than the CT.

         

HIV/AIDS Testing: ICF is required prior to HIV testing, unless the subject remains anonymous to the PI

 

Payments to Subjects: Insurers are required to reimburse for: Rx or device approved by FDA, SOC for failed CT's, initial consultation for eligibility, & expenses w/ CT monitoring

         

Drug Supply Requirements: None Specified

 

Genetic Testing: No person may obtain, disclose, or retain genetic info w/out ICF. Penalties for non-compliance

 

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: Have enacted off-label drug use laws that do not explicitly address cancer treatment, instead they refer to life-threatening conditions or generic off-label indications

 

Medically Necessary Services: Medically Necessary Services Covered

 

Experimental or Contraindicated Rx NOT Covered: Experimental &/or Contraindicated Rx NOT Covered

         

Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified

         

State Codes & Links:

All codes can be found at

http://leg.state.nv.us/

Last Updated ( Wednesday, 16 September 2015 14:40 )