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Indiana

State Legal Structure: Comply w/ Fed. Regulations

Required Notification to State Officials: Mandate coverage of off-label drug use goes to State Commissioner of Insurance

Protocol Requirements: Comply w/ Fed. Regulations

Legal Rep. Standards: Incompetent adults reps may include: parents, guardian, adult siblings power of attorney

Age of Consent: 18-minors who are married, emancipated, independent from parents & +14, or in military

Informed Consent Requirements: PI must examine & receive written ICF. Mental  pts must be informed of Dr. credentials

IRB Requirements: Comply w/ Fed. Regulations

Special Rules for Cancer Research: None Specified

HIV/AIDS Testing: Written ICF must be obtained Hospitals, Dr's, & labs are required to report any + results to IN DOH w/ no PHI. Counseling must be available.

Payments to Subjects: None Specified

Drug Supply Requirements: None Specified

Genetic Testing: IN genetic testing statues & regs address genetic testing only in the context of Criminal DNA evidence

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: None Specified

Phases Covered: None Specified

Organization Approved to Conduct: None Specified

Specific Conditions of CT Coverage: None Specified

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 NOT Covered

Experimental or Contraindicated Rx NOT Covered: Experimental &/or Contraindicated Rx NOT Covered

Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified

State Codes & Links:

All codes can be found at

http://www.in.gov/legislative/ic_iac/