E & I Disclaimer Statement for this Website

Last modified March 2, 2009.

Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.


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




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