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***PREGNANT WOMAN & INFANTS < 1 YEAR MAY NOT CONSENT TO MEDICAL RESEARCH unless there is NO risk or it is essential for life to continue ***
State Legal Structure: Comply w/ Fed. Regulations
Required Notification to State Officials: Mandate coverage of Clinical Trials goes to State Commissioner of Insurance
Protocol and IRB Requirements: When research involving investigational drug(s) and/or drug distribution is to take place in a hospital or other inpatient institution with it's own pharmacy, 1) the pharmacist must maintain a copy of each study protocol involving their patients and 2) the reviewing IRB must include a pharmacists as a full-time member.
Legal Rep. Standards: If PI feels the patient is incapable of ICF, PI can petition NM courts to appoint guardian
Age of Consent:18-minors who are married or emancipated
HIV/AIDS Testing: ICF oral or written. PI must give explanation of purpose, potential uses, & meaning of test results. Written ICF is not required if documented in subject file that discussion took place and ICF was given. Counseling must be available.
Payments to Subjects: Reimbursement must be considered payment in full. Please see insurance section for more details
Drug Supply Requirements: None Specified
Genetic Testing: Genetic info or testing can only be disclosed or retained from subject if written ICF is obtained unless there will be no PHI involved. Penalties for non-compliance
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, DOD, VA. NCI is NOT covered
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.
IRB Approval is required
Mandates for Coverage of Off-Label Rx: None Specified
Medically Necessary Services: None Specified
Experimental or Contraindicated Rx NOT Covered: None Specified
Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: Deductibles, co pays, or coinsurance requirements for Clinical Trials use may apply