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Last modified March 2, 2009.

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North Dakota

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Parents; guardians for incapacitated minors must obtain court approval

         

Age of Consent: 18-minors may consent in life-threatening medical situations w/out permission or consent from parent or guardian

         

Informed Consent Requirements: Copies of the 45 CFR 46 must be made available to individuals considering enrollment in a CT

         

IRB Requirements: None Specified

         

Special Rules for Cancer Research: Comply w/ Fed. Regulations

         

HIV/AIDS Testing: ICF must be obtained before testing or disclosure can occur. ICF must include info about the potential disclosure of results.

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: Must be labeled "For Investigational Use Only"

 

Genetic Testing: None Specified

 

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: None Specified

         

Phases Covered: Phases II, III, & IV ONLY

         

Organization Approved to Conduct: FDA, NIH, DOD, VA. NCI is  NOT covered

         

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 NOT 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

http://www.nd.gov/category.htm?id=151

&

http://www.legis.nd.gov/information/rules/admincode.html

 

 

Last Updated ( Wednesday, 16 September 2015 14:38 )