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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: Guardians, Spouses, adult children, parents, adult siblings, & POA
Age of Consent: 18-minors who are married, are parents, or who are emancipated. 16+ can consent for mental health
Informed Consent Requirements: Comply w/ Fed. Regulations
IRB Requirements: Comply w/ Fed. Regulations
Special Rules for Cancer Research: None Specified
HIV/AIDS Testing: KY requires that physicians provide or arrange a counseling referral for patients receiving HIV testing. Test results cannot be disclosed through the mail, phone, or any other type of electronic communication
Payments to Subjects: None Specified
Drug Supply Requirements: Must be labeled "For Investigational Use Only"
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 AND managed care insurers are required to provide coverage. Coverage is NOT contingent on the insurer providing 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