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State Legal Structure: Any study funded, sponsored, or mandated by the AZ Department of Health Services(HSRB) must go through an HSRB IRB. Prisoners must be approved by AZ Chief of Health Services. Also mandate Clinical Trials.
Required Notification to State Officials: To gain access to any copies of records or any other PHI, PI must write a detailed proposal to the HSRB
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Incompetent adults reps may include: parents, spouse, adult children, siblings, domestic partner, guardian, power of attorney, attending physicians, & appointed surrogates
Age of Consent: 18-minors who are married, emancipated, or homeless without parents
Informed Consent Requirements: Comply w/ Fed. Regulations
IRB Requirements: All research funded, sponsored, or conducted by the AZ Dept. of Health must go through the DOH IRB
Special Rules for Cancer Research: No hospital, medical, dental or optometric service organization are obligated to pay an costs other than covered pts. Costs.
HIV/AIDS Testing: No individual may be tested before they sign a ICF. If no PHI is being collected then it must be oral consent. If the test is during specimen testing for research then ICF provisions do not apply
Payments to Subjects: Reimbursement must be considered payment in full
Drug Supply Requirements: Hospital pharmacies must store & make info available to hospital staff. Must be labeled "For Investigational Use Only" as well as dispersal approved by hospital staff
Genetic Testing: CF (written) is required before testing begins or before info can be disclosed. Results can only be released to person tested &/or their health care decision maker, researcher, AZ Human ethics Committee Rep.,
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, & Academic Centers. NCI is NOT covered
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 as a non-investigational treatment. IRB Approval is required
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 NOT Covered
Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: Deductibles, co pays, or coinsurance requirements for both off-label drug use AND clinical trials may apply
State Codes & Links: