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New Mexico

***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 Requirements: Hospital pharmacies must maintain a copy of each study protocol involving their patients

 

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

         

Informed Consent Requirements: Comply w/ Fed. Regulations.

         

IRB Requirements: Must have one member who is a pharmacist       

 

Special Rules for Cancer Research: None Specified

         

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

         

State Codes & Links:

All codes can be found at

http://www.conwaygreene.com/nmsu/lpext.dll?f=templates&fn=main-h.htm&2.0

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http://www.nmcpr.state.nm.us/nmac/_titles.htm

Last Updated ( Wednesday, 16 September 2015 14:39 )