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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