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: Any parent whether adult or minor for his minor child or for adult child of unsound mind, whether the child is of blood, adopted, step child, or foster. Guardian of ward; Unsound mind-grandparent if parent not available, spouse, child of unsound mind adult. Any minor incarcerated can consent for thyself


Age of Consent: 18-minors who are married, emancipated, and minors with intelligence sufficient to appreciate the consequences of medical treatment


Informed Consent Requirements: Comply w/ Fed. Regulations


IRB Requirements: Comply w/ Fed. Regulations


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: ICF must be obtained before testing can occur. Counseling must also be available. Test results can not be disclosed through the mail, phone, or any other type of electronic communication. PI must report positive test results to the State DOH


Payments to Subjects: None Specified


Drug Supply Requirements: None Specified


Genetic Testing: Info regarding tissue may be disclosed for research as long as the pts. Name or SSC# is not included or the pts. Has signed ICF


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: Individual & Group insurers AND managed care insurers are required to provide coverage, IF they provide coverage for prescription drugs in general


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 the following link:



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