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State Legal Structure: Must provide to prospective subjects in their language the, "Experimental Subjects Bill of Rights". Experimental RX Study must be approved by an IRB that follows 45 CFR 46 and then the ICF must be seen by CA Dept. of Health before initiation
Required Notification to State Officials: Schedule I & II Rx's as well as research that focuses on the treatment of Rx abuse and that uses any drug regardless of what schedule must be pre-reviewed & authorized by the Research Advisory Panel of CA.
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: If the subject is unable to consent and does not express dissent or resist in a Non-Emergency setting the following in order my consent. 1.agent under an advance health care directive 2.gaurdian 3.spouse 4.domestic partner 5.adult son or daughter 6.custodial parent 7.adult sibling 8.adult grandchild 9.adult w/closest kinship. Emergency situation: all apply except 7-9.
Age of Consent: 18-minors may consent to medical care if the minor is 15+, living separate & apart from parents or guardians and is managing own financial affairs regardless of source. Mental health for 12 or older may consent if physician feels it is the best interest in the subject
Informed Consent Requirements: Provide a copy of the CA Experimental Bill of Rights. Must have witness signature.
IRB Requirements: Must comply with 45 CFR 46 and any investigation Rx Consent must be sent to CA Dept. of Health
Special Rules for Cancer Research: "Cancer Act" must submit any and all info regarding the cancer study to CA Dept. of Health. Please see pgs 21-24 of State-by-State book for detail
HIV/AIDS Testing: No individual may be tested before they sign a ICF & must be in their language. Certain language is required. After 7 days of confirmed HIV test PI must complete the Non-Name Code & report the confirmed de-identified HIV test to local Health Officer. PI may apply for exemption to the CA office of AIDS (OA)
Payments to Subjects: Subject ONLY can be paid, not any other persons whom have signed a ICF
Drug Supply Requirements: Cancer Drug must be labeled "Caution: New drug. Use in diagnosis, treatment, alleviation, or cure of cancer limited by law to investigational use"
Genetic Testing: 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: Managed care and individual and group insurers required to provide coverage
Phases Covered: All (1-4)
Organization Approved to Conduct: FDA, NIH, DOD, VA. NCI is NOT covered
Specific Conditions of CT Coverage: None Specified
Mandates for Coverage of Off-Label Rx: Have enacted off-label drug use laws that 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: Deductibles, co pays, or coinsurance requirements for Clinical Trials use may apply
State Codes & Links:
|Last Updated ( Wednesday, 16 September 2015 14:46 )|