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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

http://law.justia.com/newyork/codes/index.html

 

 

Last Updated ( Wednesday, 16 September 2015 14:39 )