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State Legal Structure: Comply w/ Fed. Regulations
Required Notification to State Officials: Mandate coverage of off-label drug use goes to State Commissioner of Insurance
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Parents, POA, & court appointed guardians may consent. Guardians of minors, incapacitated persons & mental health patients may NOT consent to Research w/out court order
Age of Consent: 18-Married minors, minor parents, & minors living independently from parents may consent
Informed Consent Requirements: State Hospital research MUST have certification from PI stating that the subject understands & is competent
IRB Requirements: Comply w/ Fed. Regulations.
Special Rules for Cancer Research: MN has a program under which provides support to researchers studying THC & marijuana on cancer patients undergoing chemotherapy
HIV/AIDS Testing: PI's, healthcare facilities, & Labs MUST report HIV results to the DOH
Payments to Subjects: None Specified
Drug Supply Requirements: None Specified
Genetic Testing: ICF (written) is required before info can be disclosed, collected, or retained.
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: Deductibles, co pays, or coinsurance requirements for off-label drug use may apply
State Codes & Links:
All codes can be found at