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Delaware

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

http://delcode.delaware.gov/

 

Last Updated ( Wednesday, 16 September 2015 14:45 )