E & I Disclaimer Statement for this Website

Last modified March 2, 2009.

Please note that E & I does not control and cannot guarantee the relevance, timeliness, or accuracy of these outside materials.

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




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