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