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: Mandate coverage of off-label drug use goes to State Commissioner of Insurance


Protocol Requirements: Comply w/ Fed. Regulations


Legal Rep. Standards: Parents & legal guardians may consent on behalf of minors (560-X-11-.11)


Age of Consent: 19-Or 14 or older, or has graduated high school, or married, or been married is divorced or is pregnant may give consent to any legally authorized medical, health or mental health services for thyself, & the consent of no other is necessary. 26-1-1, 22-8-4, r950-1-6-.03


Informed Consent Requirements: Comply w/ Fed. Regulations


IRB Requirements: Comply w/ Fed. Regulations


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: ICF must be obtained before testing can occur. Counseling must also be available. Test results can not be disclosed through the mail, phone, or any other type of electronic communication.


Payments to Subjects: None Specified


Drug Supply Requirements: Hospital pharmacies must store & dispense investigational Rx & maintain all info regarding those Rx within the pharmacy


Genetic Testing: None Specified


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: Individual & Group insurers are required to provide coverage IF they provide coverage for prescription drugs in general


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






Last Updated ( Wednesday, 16 September 2015 14:47 )