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: Un-emancipated minors or incompetent persons   may be in the following order: 1.gaurdian 2.Parent 3.Adult sibling 4.grandparent. If none available then an adult who has special care to the person


Age of Consent: 18-Subjects under the age of 18 may not participate in research w/ out guardian signature


Informed Consent Requirements: All research conducted in psychiatric facilities must obtain written ICF from all subjects 12+ along w/ parents.


IRB Requirements: Research conducted in a mental health hospital, IRB must evaluate the possible benefits & disruptions that the study could bring to the facility & submit a written report to the director of the facility


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: PI's, healthcare facilities, & Labs MUST report HIV cases & deaths to the DOH. Counseling must be provided following HIV testing. ICF is required before info can be disclosed


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: 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: None Specified


State Codes & Links:

All codes can be found at




Last Updated ( Wednesday, 16 September 2015 14:41 )