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: All persons are legally competent unless a court has appointed a guardian


Age of Consent: 18-Minors 14+ may consent to mental health


Informed Consent Requirements: Comply w/ Fed. Regulations. Along w/ reading of the ICF if the study is considered essential of understanding, plus documentation  the person(s) addressing the ICF


IRB Requirements: Comply w/ Fed. Regulations.


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: ICF is required prior to HIV testing, unless the subject remains anonymous to the PI & results are not posted to the subject. Persons other than lab staff are required to submit results to DOH. Counseling must be available


Payments to Subjects: None Specified


Drug Supply Requirements: None Specified


Genetic Testing: Genetic testing info may not be disclosed unless used in paternity cases. ICF must be obtained prior to testing


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. Coverage is NOT contingent on the insurer providing coverage for prescription drugs in general.


Medically Necessary Services: None Specified


Experimental or Contraindicated Rx NOT Covered: No Restrictions


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 14:42 )