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South Dakota

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: Mental Health studies recruiting from mental health institutes must be approved by SD Sec. of Human Services.

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Parents are considered the legal guardian of minor. All others must obtain a court order

         

Age of Consent: 18-minors who are or were married members of the armed forces or emancipated

         

Informed Consent Requirements: If PI determines the subject unable to consent, the PI can not accept the ICF

         

IRB Requirements: Comply w/ Fed. Regulations

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: A PI attending to a subject w/ a reportable disease shall report to the SD DOH. See ARSD 44:20:01:04. 02:01,

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: None Specified

 

Genetic Testing: Written ICF is required before testing

 

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

http://legis.state.sd.us/statutes/TitleList.aspx

&

http://legis.state.sd.us/rules/RulesList.aspx

 

 

Last Updated ( Wednesday, 16 September 2015 14:37 )