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Arizona

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:

http://www.azleg.state.az.us/ArizonaRevisedStatutes.asp

&

http://www.azsos.gov/public_services/table_of_contents.htm

 

 

Last Updated ( Wednesday, 16 September 2015 14:47 )