E & I Disclaimer Statement for this Website

Last modified March 2, 2009.

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


Last Updated ( Wednesday, 16 September 2015 14:40 )