Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.
State Legal Structure: Comply w/ Fed. Regulations
Required Notification to State Officials: None Specified
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Physician must determine subject ability to consent; make efforts to notify the subject of the determination, to locate persons such as spouse, parent, adult child, sibling, grandchild or close friend, once determined who, that person must authorize
Age of Consent: 18-minors may consent to medical care. If the minor is 15+, living separately from parents and married
Informed Consent Requirements: Experimental research involving developmentally disabled individuals is prohibited unless consent is obtained & non-affiliated interdisciplinary team is consulted
IRB Requirements: Comply w/ Fed. Regulations
Special Rules for Cancer Research: None Specified
HIV/AIDS Testing: Written ICF is required. All PI's must report any + tests to the DOH UNLESS the study is approved by the DOH Test results can not be disclosed through the mail, phone, or any other type of electronic communication PI must offer AIDS counseling when testing. See CRS 25-4-1402 to 1405; 25-4-401-402
Payments to Subjects: None Specified
Drug Supply Requirements: Must be labeled "For Investigational Use Only"
Genetic Testing: Genetic information is considered personal property. ICF (written) is required before info can be disclosed. There are 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: Have enacted off-label drug use laws that do not explicitly address cancer treatment, instead they refer to life-threatening conditions or generic off-label indications
Medically Necessary Services: None Specified
Experimental or Contraindicated Rx NOT Covered: None Specified
Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified
State Codes & Links:
All codes can be found at