Oklahoma State Legal Structure: Comply w/ Fed. Regulations
Required Notification to State Officials: The IRB affiliated with OK DOH must, in certain circumstances, review research protocols
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Incapacitated adults the following will take authority. 1.Spouse 2.adult child 3.parent 4.Adult sibling 5.Adullt relative by blood or marriage
Age of Consent: 18-married minors, emancipated, or minor parents may consent
Informed Consent Requirements: Comply w/ Fed. Regulations
IRB Requirements: Clients & staff of the OK DOH may not enroll w/out the OK state IRB approval unless the outside IRB receives approval from OK DOH
Special Rules for Cancer Research: None Specified
HIV/AIDS Testing: All data that identify any person who has or may have an communicable or venereal disease shall be confidential
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: No Restrictions
Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified
State Codes & Links: All codes can be found at http://www.ok.gov/3167/3512/3384/3389/ &
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Last Updated ( Wednesday, 16 September 2015 14:38 ) |