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: None Specified


Protocol Requirements: Comply w/ Fed. Regulations


Legal Rep. Standards: Conservators, health care agents, parents of minors undergoing mental health treatment & physician appointed by the court w/ regard to involuntarily committed minors


Age of Consent: 18-minors, 14+ may consent to mental health treatment provided that the parents are notified within 5 days (not found w/in the state statues)


Informed Consent Requirements: Comply w/ Fed. Regulations; minors or other incompetent individuals must have written ICF.


IRB Requirements: Comply w/ Fed. Regulations


Special Rules for Cancer Research: Insurance issued or renewed after 1/1/2002, must provide coverage SOC costs associated w/ Cancer Research


HIV/AIDS Testing: ICF must be obtained before testing can occur. Counseling must also be available


Payments to Subjects: None Specified


Drug Supply Requirements: Experts may use Investigational Rx provided that they are labeled as such (see CN 21a-110)


Genetic Testing: None Specified

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: Individual and group insurers required to provide coverage


Phases Covered: Phase III


Organization Approved to Conduct: FDA, NIH, NCI, DOD, & VA


Specific Conditions of CT Coverage: Data provide a reasonable expectation that the treatment will be at least as efficacious as a non-investigational treatment. IRB Approval is required


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 off-label drug use may apply


State Codes & Links:

All codes can be found at



Last Updated ( Wednesday, 16 September 2015 14:46 )