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: Any CT involving NC mental health patients, a protocol must be submitted to the Deputy Secretary of Mental Health


Protocol Requirements: Comply w/ Fed. Regulations


Legal Rep. Standards: Parents are guardians for their children. Incompetent persons, no on may consent, PI must have a court order


Age of Consent: 18-or High school graduate, a parent, or married


Informed Consent Requirements: Copies of the 45 CFR 46 must be made available to individuals considering enrollment in a CT


IRB Requirements: Comply w/ Fed. Regulations


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: IRB approved research does NOT require ICF and pre-test counseling prior to HIV testing. Please see 35 PS 7605 (f). ICF required before disclosure. Counseling must be available


Payments to Subjects: None Specified


Drug Supply Requirements: None Specified


Genetic Testing: None Specified


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: None Specified


Medically Necessary Services: None Specified


Experimental or Contraindicated Rx NOT Covered: None Specified


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 14:37 )