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: A wife & husband are the joint natural guardians. If parents live apart the court may award guardianship to either parent


Age of Consent: 18-minors, 14+ may consent to mental health treatment


Informed Consent Requirements: If a child is to participate in a more than minimal risk study, both parents must sign ICF. If subject says no to treatment it is the final say


IRB Requirements: Must include minority group representation in the same proportion of the study population


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: ICF, written or oral, must include: explanation of the test, purpose, potential uses, voluntary nature of the test, & meaning of results. ICF is required before disclosure can occur. Counseling must be available


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: None Specified


Organization Approved to Conduct: None Specified


Specific Conditions of CT Coverage: None Specified


Mandates for Coverage of Off-Label Rx: Has off-label drug use laws that address both cancer & specific use in generic use


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 14:38 )