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: 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 )