E & I Disclaimer Statement for this Website

Last modified March 2, 2009.

Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.


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Informed Consent Requirements: ICF may be withdrawn at any time and in any way by the subject.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





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