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Massachusetts 

**Any studies involving schedule 2 narcotics that will be stored at the study site/PI location are subject to a site audit at least once a year by the IRB**

 

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: Schedule II narcotics or the use of "new drugs"  must provide info to the Commissioner of Public Health.

         

Protocol Requirements: Must identify who is in charge & qualifications, how the drug will be used

 

Legal Rep. Standards: ICF can not be given on behalf of a minor who has refused consent. Guardians, POA, & healthcare proxies

         

Age of Consent: 18-minors who are married, are parents, members of the armed forces or emancipated

         

Informed Consent Requirements: Comply w/ Fed. Regulations statement of understanding, Q&A, & withdrawal

         

IRB Requirements: Comply w/ Fed. Regulations Must be affiliated w/ hospital

         

Special Rules for Cancer Research: Cancer treatment will be reimbursed if it is used for therapeutic studies

         

HIV/AIDS Testing: Counseling must be made available

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: None Specified

 

Genetic Testing: No ICF is needed if results will be used only in epidemiological or clinical research conducted for the purpose of developing scientific knowledge about genes, genetic bases of diseases or treatment. All other: written ICF is required before disclosure and testing. Violations for non-compliance

 

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, IF they provide coverage for prescription drugs in general

 

Medically Necessary Services: Medically Necessary Services Covered

 

Experimental or Contraindicated Rx NOT Covered: Contraindicated drug NOT covered    

Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: Deductibles, co pays, or coinsurance requirements for off-label drug use may apply

         

State Codes & Links:

All codes can be found at

http://www.mass.gov/legis/laws/mgl/index.htm

 

 

 

Last Updated ( Wednesday, 16 September 2015 14:42 )