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: Parents & legal guardians may consent on behalf of minors. Individuals acting as attorney-in-fact for pts. Undergoing mental health treatment may consent  

Age of Consent: 18-minors who are married, financially independent & residentially independent from parents may consent


Informed Consent Requirements: Pts. in mental health institutions can give consent only when info is provided in a manner that ensures max. comprehension. Must be legally "competent"


IRB Requirements: Comply w/ Fed. Regulations


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: None Specified


Payments to Subjects: None Specified


Drug Supply Requirements: Rx may be administered by pts. By qualified experts provided that drug's are labeled "For Investigational Use Only"


Genetic Testing: ICF (written) is required to test or gather info. General authorization for release does not constitute ICF. Genetic info is considered personal property.


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: 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






Last Updated ( Wednesday, 16 September 2015 14:47 )