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.


State Legal Structure: Comply w/ Fed. Regulations


Required Notification to State Officials: None Specified


Protocol Requirements: Comply w/ Fed. Regulations


Legal Rep. Standards: Guardians, POA, appointed by healthcare directive, parents, spouses, adult children, relatives, siblings and grandparents


Age of Consent: 18-married minors, minors living independently for more than 60 days, minors serving in the military & emancipated. Minors 12-18 who have NOT been declared incapacitated can consent in CT's along w/ guardian consent


Informed Consent Requirements: Comply w/ Fed. Regulations; minors or other incompetent individuals must have written ICF.


IRB Requirements: A Research & Experiment Review Board maintained by facility in which study is conducted must oversee research regarding Div. of Mental Health & Bureau of Children w/ Special Needs


Special Rules for Cancer Research: None Specified


HIV/AIDS Testing: See 5 M.R.S.A. §19201-204 Written ICF is NOT required if no PHI is being gathered. See 5 MRSA 19201-204 for the regulation in its entirety. Test results can't be disclosed through the mail, phone, or any other type of electronic communication. Counseling must be available


Payments to Subjects: None Specified


Drug Supply Requirements: None Specified


Genetic Testing: All DNA records are considered confidential & may not be disclosed to any person or agency except gov. CJ & law enforcement agencies for ID purposes in criminal investigations


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




Last Updated ( Wednesday, 16 September 2015 14:43 )