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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

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