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/
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Last Updated ( Wednesday, 16 September 2015 14:44 ) |