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State Legal Structure: Comply w/ Fed. Regulations
Required Notification to State Officials: None Specified
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Guardians MUST be approved by the court in order to consent to Research Trials
Age of Consent: 18-No exceptions
Informed Consent Requirements: Comply w/ Fed. Regulations
IRB Requirements: Comply w/ Fed. Regulations.
Special Rules for Cancer Research: Insurance requirements only, see insurance section
HIV/AIDS Testing: For research not gathering PHI, ICF is not required. If gathering PHI, ICF is required w/ discussion of + & - findings. Counseling must be made available.
Payments to Subjects: Insurance requirements only, see insurance section. Along w/: the insurance company has a right to see the signed ICF
Drug Supply Requirements: None Specified
Genetic Testing: No one may disclose the results of genetic testing or the fact that the person has undergone testing w/out ICF. If subject agrees in ICF s/he can be notified of results
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) I & II are case-by-case basis
Organization Approved to Conduct: FDA, NIH, & VA. NCI & DOD are NOT included
Specific Conditions of CT Coverage: Personnel providing treatment are doing so within their scope of practice, experience, and training AND 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.
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
|Last Updated ( Wednesday, 16 September 2015 14:40 )|