Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.
State Legal Structure: VA Explicitly exempts CT's that are subject to Fed. Regs. From having to comply w/ CT provisions made by VA
Required Notification to State Officials: Studies involving mental Health subjects at a VA mental health institute MUST be provided to the Commissioner of the VA DOH
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: The following may act as legal rep:1.parent 2.agent appointed to make health care decisions 3.legal guardian 4. Spouse 5.adult Child 6.parent if subject is an adult 7. Adult sibling 8. Court appointed individual
Age of Consent: 18-minors who are married, are parents, members of the armed forces or emancipated
Informed Consent Requirements: costs and or payments to subjects must be clearly addressed, must include a statement indicating that there may be unidentified risks. Subject MUST have the option to linking him/herself to research whether or not the study indicates. Witness signature is required.
IRB Requirements: Comply w/ Fed. Regulations
Special Rules for Cancer Research: None Specified
HIV/AIDS Testing: HIV test results are confidential. ICF must be obtained before disclosure. Counseling must be available
Payments to Subjects: None Specified
Drug Supply Requirements: IND Must be on file
Genetic Testing: All results from a screening program must be sent to the person tested, the PI, and parent if the subject is under 18. ICF is required before disclosure.
Cancer Insurance Section
Mandates for Coverage of CT Trials & Insurer: Managed care and individual and group insurers required to provide coverage
Phases Covered: All (1-4) Phase I will be a case-by-case basis
Organization Approved to Conduct: FDA, NCI & VA ONLY. NIH & DOD is NOT
Specific Conditions of CT Coverage: No clearly superior, non-investigational treatment exists AND data provide a reasonable expectation that the treatment will be at least as efficacious as a non-investigational treatment. IRB Approval is required
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: Experimental &/or Contraindicated Rx NOT Covered
Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: Deductibles, co pays, or coinsurance requirements for Clinical Trials use may apply
State Codes & Links:
All codes can be found at