Home State Regulations
US-ME
Print

E & I Disclaimer Statement hot milf
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.

Maine

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

http://janus.state.me.us/legis/

 

 

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