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State Legal Structure: If research does not fall into any of the RCHS categories than IRB's must comply with Federal Regulations
Required Notification to State Officials: If any research is funded, conducted, or enrolling from the Dept. of Health (DOH) or Dept. of Children & Family (DCF) the protocol MUST be reviewed by the Review Council for Human Subject (RCHS)
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Incapacitated patients who do not have a representative the following will take authority. 1.Judicially appointed guardian 2.Spouse 3.adult child 4.parent 5.Adult sibling 6.Adullt relative whom has special care & concern 7.Close Friend 8.State Social worker
Age of Consent: 18-Married minors, minors over 16 w/ judicial approval & pregnant minors
Informed Consent Requirements: Comply w/ Fed. Regulations & ICF must be retained for 3 years after study completion.
IRB Requirements: Must evaluate: 1.Subject population 2.Recruited w/out coercion 3.Appropriate design 4.Min. Risks 5.Max benefits 6.Benefits=Risk ratio 7.Remuneration offered is fair 8.Confidentiality 9.ICF ethical 10.PI qualified
Special Rules for Cancer Research: None Specified
HIV/AIDS Testing: Positive test results must be reported to DOH-not required for University testing. If no PHI then ICF is not needed.
Payments to Subjects: IRB Must review and deem non-coercive
Drug Supply Requirements: None Specified
Genetic Testing: DNA analysis only if ICF obtained. Noticed must be given to the subject once analysis has occurred. Genetic Info is considered Personal Property. ICF must be obtained to disclose genetic info. Penalties if the laws are not enforced.
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 Covered
Experimental or Contraindicated Rx NOT Covered: Contraindicated drug 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 14:45 )|