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: Mandate coverage of Clinical Trials goes to State Commissioner of Insurance


Protocol Requirements: Comply w/ Fed. Regulations


Legal Rep. Standards: Judicial appointees, parents, spouses, adult children, siblings, ascendant/descendant, guardians


Age of Consent: 18-minors 16+ may be judicially emancipated are able to consent for research


Informed Consent Requirements: See La. R.S. §§ 40:1299.40 & .58


IRB Requirements: See La. R.S. §40:1299.40


Special Rules for Cancer Research: Insurance requirements only, see insurance section


HIV/AIDS Testing: See La. R. S. §§40:1300.13 The Subject MUST stay anonymous unless Written ICF states otherwise. Test results cannot be disclosed through the mail, phone, or any other type of electronic communication. Counseling must be available


Payments to Subjects: None Specified


Drug Supply Requirements: None Specified


Genetic Testing: Genetic information is considered personal property. ICF (written) is required before info can be disclosed.  There are penalties for non-compliance.


Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: Managed care and individual and group insurers required to provide coverage


Phases Covered: Phases II, III, & IV ONLY


Organization Approved to Conduct: FDA, NIH, DOD, VA. NCI is  NOT covered


Specific Conditions of CT Coverage: Personnel providing treatment are doing so w/in their scope of practice, experience, and training AND no clearly superior, non-investigational treatment exists AND data provide a reasonable expectation that 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: Contraindicated drug not covered       

Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: Deductibles, co pays, or coinsurance requirements for Clinical Trials use may apply


State Codes & Links:

All codes can be found at




Last Updated ( Wednesday, 16 September 2015 14:43 )