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: If research is conducted in Mobile Intensive Care Units (MIC Units) NJ DOH & sponsoring hospital IRB will need to approve
Protocol Requirements: Comply w/ Fed. Regulations
Legal Rep. Standards: Court appointed guardians may consent for minors whose parents are deceased or for an elderly subject
Age of Consent: 18-married minors & minor parents may consent
Informed Consent Requirements: Comply w/ Fed. Regulations.
IRB Requirements: Comply w/ Fed. Regulations.
Special Rules for Cancer Research: None Specified
HIV/AIDS Testing: ICF is required. At study completion or subject withdraws samples must be destroyed. Info may not be kept w/out ICF unless no PHI. Subj. has right to request results. Penalties for non-compliance
Payments to Subjects: None Specified
Drug Supply Requirements: None Specified
Genetic Testing: ICF is required. At study completion or subject withdraws samples must be destroyed. Info may not be kept w/out ICF unless no PHI. Subj. has right to request results
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: 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