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Tennessee

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: If the protocol has NOT been approved by the FDA AND the study involves a controlled substance or prescription Rx then the PI must be approved by the TN Pharm. Board

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Parents (minors included) are considered the natural guardian of their child

         

Age of Consent: 18-See TN Code Ann. §1-3-105

         

Informed Consent Requirements: Comply w/ Fed. Regulations

         

IRB Requirements: Comply w/ Fed. Regulations

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: All subjects being treated for STD's, PI must provide printed instructions from the TN DOH-See TN Cde Ann. §68-10-103

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: Must be labeled "For Investigational Use Only". All reports of the investigations must be furnished to the Commissioner of Agriculture upon request

 

Genetic Testing: Info collected & analyzed for the purpose of the birth defects registry is confidential & may not be used for any other purpose unless scientific research is approved by an IRB

 

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: 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: 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.michie.com/tennessee/lpext.dll?f=templates&fn=main-h.htm&cp=tncode

 

 

Last Updated ( Wednesday, 16 September 2015 14:36 )