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State Legal Structure: Comply w/ Fed. Regulations
Required Notification to State Officials: Researchers seeking to enroll state hospital patients must apply for permission from MO Office of Departmental Affairs prior to initiating
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: The following may consent on behalf of adult who is incapable: Spouse, Adult Child, parent, sibling, relative by blood or marriage. If subject declined no one else may consent
Age of Consent: 18-married minors & minor parents may consent
Informed Consent Requirements: MO prohibits research involving involuntary committed mental health patients. Written ICF from subject & guardian is required for mental health studies
IRB Requirements: Comply w/ Fed. Regulations.
Special Rules for Cancer Research: Health Insurers must cover SOC associated w/ Phase's III & IV for prevention, early detection, or treatment. Non-investigational alternatives must be available.
HIV/AIDS Testing: IRB's need to report + HIV findings w/out PHI and with a unique patient identifier number to DOH within 3 days
Payments to Subjects: None Specified
Drug Supply Requirements: Must be labeled "For Investigational Use Only"
Genetic Testing: No person may obtain or disclose genetic info w/out ICF. Penalties for non-compliance
Cancer Insurance Section
Mandates for Coverage of CT Trials & Insurer: None Specified
Phases Covered: Phases III & IV ONLY
Organization Approved to Conduct: FDA, NIH, DOD, VA, NCI is NOT covered
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
Code of State Regulations can be found at
|Last Updated ( Wednesday, 16 September 2015 14:41 )|