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State Legal Structure: Comply w/ Fed. Regulations
Required Notification to State Officials: IRB's within Hospitals are required to review all protocols, write acceptance/denial letter to State Dept. of Health within 30 days of review & have minutes available. Mandate coverage of off-label drug use goes to State Commissioner of Insurance
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Patients guardian, spouse, parent, or authorized agent may consent on behalf of patient
Age of Consent: 18-Married minors, minor parents, emancipated or pregnant minors may consent to medical treatments.
Informed Consent Requirements: Comply w/ Fed. Regulations; minors or other incompetent individuals must have written ICF.
IRB Requirements: Comply w/ Fed. Regulations-Hospital IRB's must submit to DOH
Special Rules for Cancer Research: Cancer studies using marijuana, a written ICF must be obtained before drug is given
HIV/AIDS Testing: Written ICF explaining why the test is being done, the results, counseling referral, & a notice that the test is voluntary. Subject has the option for no PHI. If no PHI no written ICF is needed. Test results cannot be disclosed through the mail, phone, or any other type of electronic communication
Payments to Subjects: None Specified
Drug Supply Requirements: Must be labeled "For Investigational Use Only" along with name, strength, exp. Date, reference code, and lost # as well as name and location of patient
Genetic Testing: Genetic Info can only be seen by the person tested, whom s/he authorizes in writing, research team conducting the tests, & if a minor, s/he parents must authorize. ICF must be obtained to disclose genetic info. Penalties if privacy 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: Phases II, III, & IV ONLY
Organization Approved to Conduct: FDA & NIH ONLY
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, IF they provide coverage for prescription drugs in general
Medically Necessary Services: Medically Necessary Services Covered
Experimental or Contraindicated Rx NOT Covered: Experimental &/or Contraindicated Rx NOT Covered
Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified
State Codes & Links:
All codes can be found at