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: An Appointed guardian, Spouse, Adult child, parent, adult sibling, close friend
Age of Consent: 18-minors who are married, are parents. 16+ can consent for mental health
Informed Consent Requirements: Comply w/ Fed. Regulations
IRB Requirements: Upon request & w/in 30 days of an IRB meeting, minutes must be available for inspection. IRB may redact any PHI before disclosure
Special Rules for Cancer Research: Insurance requirements only, see insurance section
HIV/AIDS Testing: Labs report findings of HIV/AIDS to DOH. Info includes a system of HIV code numbering to not use PHI. Test results can't be disclosed through the mail, phone, or any other type of electronic communication. Counseling must be available
Payments to Subjects: Insurers, non-profit health service plans, & HMO's are required to reimburse costs for CT's if therapeutic, prevention, or early detection of cancer.
Drug Supply Requirements: Sponsors must obtain a signed agreement from PI stating that the PI is responsible for subject & will not supply drug to any other person
Genetic Testing: ICF (written) is required before info can be disclosed.
Cancer Insurance Section
Mandates for Coverage of CT Trials & Insurer: Managed care and individual and group insurers required to provide coverage
Phases Covered: All (1-4)
Organization Approved to Conduct: FDA, NCI & VA ONLY. NIH & DOD is NOT
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: Have enacted off-label drug use laws that do not explicitly address cancer treatment, instead they refer to life-threatening conditions or generic off-label indications
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 14:42 )|