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: All persons are legally competent unless a court has appointed a guardian
Age of Consent: 18-Minors 14+ may consent to mental health
Informed Consent Requirements: Comply w/ Fed. Regulations. Along w/ reading of the ICF if the study is considered essential of understanding, plus documentation the person(s) addressing the ICF
IRB Requirements: Comply w/ Fed. Regulations.
Special Rules for Cancer Research: None Specified
HIV/AIDS Testing: ICF is required prior to HIV testing, unless the subject remains anonymous to the PI & results are not posted to the subject. Persons other than lab staff are required to submit results to DOH. Counseling must be available
Payments to Subjects: None Specified
Drug Supply Requirements: None Specified
Genetic Testing: Genetic testing info may not be disclosed unless used in paternity cases. ICF must be obtained prior to testing
Cancer Insurance Section
Mandates for Coverage of CT Trials & Insurer: None Specified
Phases Covered: None Specified
Organization Approved to Conduct: None Specified
Specific Conditions of CT Coverage: None Specified
Mandates for Coverage of Off-Label Rx: Individual & Group insurers AND managed care insurers are required to provide coverage. Coverage is NOT contingent on the insurer providing coverage for prescription drugs in general.
Medically Necessary Services: None Specified
Experimental or Contraindicated Rx NOT Covered: No Restrictions
Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified
State Codes & Links:
All codes can be found at