E & I Disclaimer Statement for this Website

Last modified March 2, 2009.

Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.


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 )