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Last modified March 2, 2009.

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New Hampshire

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Guardians MUST be approved by the court in order to consent to Research Trials

         

Age of Consent: 18-No exceptions

         

Informed Consent Requirements: Comply w/ Fed. Regulations

         

IRB Requirements: Comply w/ Fed. Regulations.

         

Special Rules for Cancer Research: Insurance requirements only, see insurance section

         

HIV/AIDS Testing: For research not gathering PHI, ICF is not required. If gathering PHI, ICF is required w/ discussion of + & - findings. Counseling must be made available.

 

Payments to Subjects: Insurance requirements only, see insurance section. Along w/: the insurance company has a right to see the signed ICF

         

Drug Supply Requirements: None Specified

 

Genetic Testing: No one may disclose the results of genetic testing or the fact that the person has undergone testing w/out ICF. If subject agrees in ICF s/he can be notified of results

Cancer Insurance Section

Mandates for Coverage of CT Trials & Insurer: Managed care and individual and group insurers required to provide coverage

         

Phases Covered: All (1-4) I & II are case-by-case basis

         

Organization Approved to Conduct: FDA, NIH, & VA. NCI & DOD are NOT included

         

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.

 

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: No Restrictions

         

Deductible, Co-payments, or Coinsurance Req. for off-Label Rx: None Specified

         

State Codes & Links:

All codes can be found at

http://www.nh.gov/government/laws.html

 

 

Last Updated ( Wednesday, 16 September 2015 14:40 )