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: None Specified
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Custodial parent or court-appointed guardian may serve as the legal representative
Age of Consent: 19-an emancipated minor may consent
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 include an explanation of the test, purpose, potential uses, voluntary nature of the test, & meaning of test results
Payments to Subjects: None Specified
Drug Supply Requirements: None Specified
Genetic Testing: ICF is required before testing. Test Lab must protect the confidentiality of genetic testing material, except as required for a paternity test
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