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Last modified March 2, 2009.

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New York

State Legal Structure: Comply w/ Fed. Regulations


Required Notification to State Officials: Commissioner of DOH approval is required for studies involving minors, incompetent, mentally disabled, or prisoners


Protocol Requirements: Comply w/ Fed. Regulations


Legal Rep. Standards: Minor subjects must have parent/guardians signature. Adult who is not able to provide consent must have the person legally empowered to act on their behalf


Age of Consent: 18-minors who are married, emancipated, or have had child(ren)


Informed Consent Requirements: MUST be written consent. Oral is not accepted


IRB Requirements: Any NY institution that conducts research MUST establish a Human Research Review Committee (HRRC) and HRRC MUST be approved by the NY DOH.


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. Counseling must be available


Payments to Subjects: None Specified


Drug Supply Requirements: Must be labeled "For Investigational Use Only"


Genetic Testing: Must obtain ICF prior to testing. Penalties 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 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 14:39 )