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Rhode Island

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: Any research involving RI staff, data, or other resources must be approved by the RI DOH IRB

         

Protocol Requirements: Each person involved w/ research must document that s/he received research training

 

Legal Rep. Standards: Parents are considered the legal guardian of a minor. All other persons must obtain a court order

         

Age of Consent: 18-minors who are married, are parents. 16+ can consent for mental health      

Informed Consent Requirements: Written ICF is required for nursing home, mental health, and home care subjects

         

IRB Requirements: Staff, data, or other resources of the RI DOH may not enroll or gather info w/out the RI state IRB approval

         

Special Rules for Cancer Research: Insurance requirements only, see insurance section

         

HIV/AIDS Testing: PI must explain the implications of the HIV prior to ICF and testing. ICF required before disclosure. Counseling must be available

 

Payments to Subjects: None Specified

         

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

 

Genetic Testing: Tests conducted purely for research by the Fed. Policy for Protection of Human Research Subjects, ICF is not required. ICF is required to disclose genetic info

 

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: Managed care and individual and group insurers required to provide coverage. Law does not specifically require coverage of routine patient care costs, which typically include any costs or services usually covered by the policy

         

Phases Covered: Phases II, III, & IV ONLY

         

Organization Approved to Conduct: FDA, NIH, NCI, & VA. DOD is not included

         

Specific Conditions of CT Coverage: Personnel providing treatment are doing so within their scope of practice, experience, and training AND no clearly superior, non-investigational treatment exists AND data provide a reasonable expectation that the treatment will be at least as efficacious

 

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: Experimental &/or Contraindicated Rx 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

http://www.rilin.state.ri.us/Statutes/

 

 

Last Updated ( Wednesday, 16 September 2015 14:37 )