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Alabama

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: Mandate coverage of off-label drug use goes to State Commissioner of Insurance

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Parents & legal guardians may consent on behalf of minors (560-X-11-.11)

         

Age of Consent: 19-Or 14 or older, or has graduated high school, or married, or been married is divorced or is pregnant may give consent to any legally authorized medical, health or mental health services for thyself, & the consent of no other is necessary. 26-1-1, 22-8-4, r950-1-6-.03

         

Informed Consent Requirements: Comply w/ Fed. Regulations

         

IRB Requirements: Comply w/ Fed. Regulations

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: ICF must be obtained before testing can occur. Counseling must also be available. Test results can not be disclosed through the mail, phone, or any other type of electronic communication.

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: Hospital pharmacies must store & dispense investigational Rx & maintain all info regarding those Rx within the pharmacy

         

Genetic Testing: None Specified

 

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: Experimental &/or Contraindicated Rx NOT Covered      

         

Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified

         

State Codes & Links:

All codes can be found at

http://www.alabamainteractive.org/alabamainteractive_shell/Welcome.do?url=http://alisdb.legislature.state.al.us/acas/CodeOfAlabama/1975/coatoc.htm

&

http://www.legislature.state.al.us/codeofalabama/1975/22-8-4.htm

 

 

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