E & I Disclaimer Statement for this Website

Last modified March 2, 2009.

Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.


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 )