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Last modified March 2, 2009.

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Georgia

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

http://www.lexis-nexis.com/hottopics/gacode/

http://rules.sos.state.ga.us/cgi-bin/page.cgi?d=1

Last Updated ( Wednesday, 16 September 2015 14:45 )