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Missouri

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

http://www.moga.mo.gov/STATUTES/STATUTES.HTM

Code of State Regulations can be found at

http://www.sos.mo.gov/adrules/csr/csr.asp

 

 

 

Last Updated ( Wednesday, 16 September 2015 14:41 )