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: None Specified


Protocol Requirements: Comply w/ Fed. Regulations


Legal Rep. Standards: Parents, guardians, spouses, custodians, & relatives with documented authority may consent for incompetent subjects


Age of Consent: 18-Married minors may consent


Informed Consent Requirements: If the psychiatrist states that the patient is unable to consent they may not participate in research. Prisoners must be approved by the courts. Consent may be waived only if 1. Unsuccessful attempt to consent to a patient who is not responding to SOP. 2. the experiment is in the best interest


IRB Requirements: For state-run mental health projects, a state ran IRB must 1st review the protocol, the IRB must comprise 12 members, no more than 6 employees of the Dept. of Health, & no more than 3 of the psychiatric center. Must be approved by 8 out of 12


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: Written ICF is required prior to HIV testing, unless the subject remains anonymous to the PI. Please see 1202 for ICF requirements Counseling must be available as well


Payments to Subjects: Health Insurance must cover for life threatening diseases. Investigational procedures/services are covered by the sponsors


Drug Supply Requirements: None Specified


Genetic Testing: No person may disclose or obtain genetic info w/out ICF. Once the authorized testing has taken place the samples must be destroyed. Info may not be kept w/out ICF unless the sample has no PHI. Penalties if the laws are not enforced

Cancer Insurance Section

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


Phases Covered: None Specified


Organization Approved to Conduct: None Specified   

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.


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 14:45 )