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: The following may consent on behalf of a child or adult who is incapable:1.parent 2.Spouse 3.court appointed guardian 4.adult Child 5.sibling 6. Grandparent


Age of Consent: 18-Married minors may consent


Informed Consent Requirements: Written doc. describing  required elements of ICF must be provided to disabled subject & subject's rep. The subject's capacity to consent MUST be reviewed by an interdisciplinary board may consult w/ a psychologist


IRB Requirements: The state registrar may require an IRB approval before allowing a PI to gain access to vital subject records maintained by the state


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: HIV test results are confidential and may be released only upon written ICF


Payments to Subjects: None Specified


Drug Supply Requirements: None Specified


Genetic Testing: Violations for Non-compliance


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 14:36 )