E & I Disclaimer Statement for this Website

Last modified March 2, 2009.

Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.


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




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