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Last modified March 2, 2009.

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Minnesota

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

https://www.revisor.leg.state.mn.us/pubs/

 

 

Last Updated ( Wednesday, 16 September 2015 14:41 )