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.


**Any studies involving schedule 2 narcotics that will be stored at the study site/PI location are subject to a site audit at least once a year by the IRB**


State Legal Structure: Comply w/ Fed. Regulations


Required Notification to State Officials: Schedule II narcotics or the use of "new drugs"  must provide info to the Commissioner of Public Health.


Protocol Requirements: Must identify who is in charge & qualifications, how the drug will be used


Legal Rep. Standards: ICF can not be given on behalf of a minor who has refused consent. Guardians, POA, & healthcare proxies


Age of Consent: 18-minors who are married, are parents, members of the armed forces or emancipated


Informed Consent Requirements: Comply w/ Fed. Regulations statement of understanding, Q&A, & withdrawal


IRB Requirements: Comply w/ Fed. Regulations Must be affiliated w/ hospital


Special Rules for Cancer Research: Cancer treatment will be reimbursed if it is used for therapeutic studies


HIV/AIDS Testing: Counseling must be made available


Payments to Subjects: None Specified


Drug Supply Requirements: None Specified


Genetic Testing: No ICF is needed if results will be used only in epidemiological or clinical research conducted for the purpose of developing scientific knowledge about genes, genetic bases of diseases or treatment. All other: written ICF is required before disclosure and testing. Violations for non-compliance


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 Covered


Experimental or Contraindicated Rx NOT Covered: Contraindicated drug 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 14:42 )