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 )|