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: Parents; guardians for incapacitated minors must obtain court approval
Age of Consent: 18-minors may consent in life-threatening medical situations w/out permission or consent from parent or guardian
Informed Consent Requirements: Copies of the 45 CFR 46 must be made available to individuals considering enrollment in a CT
IRB Requirements: None Specified
Special Rules for Cancer Research: Comply w/ Fed. Regulations
HIV/AIDS Testing: ICF must be obtained before testing or disclosure can occur. ICF must include info about the potential disclosure of results.
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: Phases II, III, & IV ONLY
Organization Approved to Conduct: FDA, NIH, DOD, VA. NCI is NOT covered
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, IF they provide coverage for prescription drugs in general
Medically Necessary Services: Medically Necessary Services NOT 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