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: The following may consent on behalf of a child or adult who is incapable:1.parent 2.Spouse 3.adult Child 4.adult parents 5. Adult sibling 6. Grandparent or adult grandchild 7.Close friend 8.Person appointed by court
Age of Consent: 18-or emancipated minors, or if PI is authorized to determine whether or not a minor is capable of understanding
Informed Consent Requirements: Comply w/ Fed. Regulations, must be written ICF
IRB Requirements: Comply w/ Fed. Regulations
Special Rules for Cancer Research: Insurance requirements only, see insurance section
HIV/AIDS Testing: Written ICF is NOT required if no PHI is being gathered. Counseling must be available.
Payments to Subjects: Insurance requirements only, see insurance section.
Drug Supply Requirements: None Specified
Genetic Testing: None Specified
Cancer Insurance Section
Mandates for Coverage of CT Trials & Insurer: None Specified
Phases Covered: Phases II, III, & IV ONLY
Organization Approved to Conduct: FDA, NIH, & VA. NCI & DOD are NOT included
Specific Conditions of CT Coverage: None Specified
Mandates for Coverage of Off-Label Rx: None Specified
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