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Utah

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: The following may consent on behalf of a child or adult who is incapable:1.parent 2.Spouse 3.court appointed guardian 4.adult Child 5.sibling 6. Grandparent

         

Age of Consent: 18-Married minors may consent

         

Informed Consent Requirements: Written doc. describing  required elements of ICF must be provided to disabled subject & subject's rep. The subject's capacity to consent MUST be reviewed by an interdisciplinary board may consult w/ a psychologist

         

IRB Requirements: The state registrar may require an IRB approval before allowing a PI to gain access to vital subject records maintained by the state

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: HIV test results are confidential and may be released only upon written ICF

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: None Specified

 

Genetic Testing: Violations for Non-compliance

 

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

http://le.utah.gov/Documents/code_const.htm

&

http://www.rules.utah.gov/main/index.php?module=Pagesetter&func=viewpub&tid=1&pid=9

 

Last Updated ( Wednesday, 16 September 2015 14:36 )