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State Legal Structure: Comply w/ Fed. Regulations
Required Notification to State Officials: Mandate coverage of off-label drug use & Clinical Trials goes to State Commissioner of Insurance
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Spouse, individuals w/ POA, parents of minors, guardians, adult children, siblings, grandparents & parents of adult children may act as legal reps.
Age of Consent: 18-Married minors may consent
Informed Consent Requirements: Comply w/ Fed. Regulations
IRB Requirements: Comply w/ Fed. Regulations
Special Rules for Cancer Research: Some cancer patients may use marijuana in therapeutic research. PI must submit application to GA patient Qualification Review Board
HIV/AIDS Testing: See G.A. code 31-22-9.1-9.2, 24-9-40
Payments to Subjects: Health plans are required to cover SOC costs.
Drug Supply Requirements: Must be labeled "For Investigational Use Only". Pharmacy must maintain info regarding the Investigational drug
Genetic Testing: No person may obtain or disclose genetic info w/out ICF. Info may not be kept w/out ICF unless the sample has no PHI. Gen. info. Is considered personal property. Penalties if laws are not enforced
Cancer Insurance Section
Mandates for Coverage of CT Trials & Insurer: Only requires coverage of Clinical Trials for dependent children
Phases Covered: Phases II & III only
Organization Approved to Conduct: FDA & NCI ONLY
Specific Conditions of CT Coverage: None Specified
Mandates for Coverage of Off-Label Rx: Individual & Group insurers are required to provide coverage IF they provide coverage for prescription drugs in general
Medically Necessary Services: Medically Necessary Services NOT 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. Law states that general "Cost-Sharing Arrangements" may apply
State Codes & Links:
All codes can be found at