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Texas

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: Studies involving IND's MUST be provided to the Commissioner of the TX DOH

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Incapacitated adults the following will take authority. 1.Spouse 2.adult child 3.parent 4.nearest living relative. Child Consent-following will take authority 1.Parent 2.Grandparent 3.adult sibling 4.adult aunt or uncle 5.School of child

         

Age of Consent: 18-Married minors, minors 16+, or pregnant minors

         

Informed Consent Requirements: ICF may be withdrawn at any time and in any way by the subject. Studies conducted at a TX Mental Health facility apply: any extension due to study, ratio of arm selection

         

IRB Requirements: Comply w/ Fed. Regulations and note how regulations are being met

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: AIDS tests are confidential and require written ICF. Results can be seen by subject, spouse, or for purposes of developing a statistical summary where there is no PHI

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: Must be labeled "For Investigational Use Only"

 

Genetic Testing: Samples MUST be destroyed promptly after fulfilling it's purpose UNLESS 1.sample is a court order 2.Subject authorized extension 3.IRB & PI requests. Written ICF must be obtained before disclosure

 

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: None Specified

 

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

http://info.sos.state.tx.us/pls/pub/readtac$ext.viewtac

&

http://tlo2.tlc.state.tx.us/statutes/statutes.html

 

Last Updated ( Wednesday, 16 September 2015 14:36 )