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: Mental Health Subjects in a Mental health facility must obtain written ICF from the subject if competent, guardian, and parent if under 18.
Age of Consent: 18-or emancipated minors
Informed Consent Requirements: Comply w/ Fed. Regulations.
IRB Requirements: Comply w/ Fed. Regulations.
Special Rules for Cancer Research: No available treatment is considered superior than the CT.
HIV/AIDS Testing: ICF is required prior to HIV testing, unless the subject remains anonymous to the PI
Payments to Subjects: Insurers are required to reimburse for: Rx or device approved by FDA, SOC for failed CT's, initial consultation for eligibility, & expenses w/ CT monitoring
Drug Supply Requirements: None Specified
Genetic Testing: No person may obtain, disclose, or retain genetic info w/out ICF. Penalties for non-compliance
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: Have enacted off-label drug use laws that do not explicitly address cancer treatment, instead they refer to life-threatening conditions or generic off-label indications
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