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Last modified March 2, 2009.

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Michigan

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: All persons are legally competent unless a court has appointed a guardian

         

Age of Consent: 18-Minors 14+ may consent to mental health

         

Informed Consent Requirements: Comply w/ Fed. Regulations. Along w/ reading of the ICF if the study is considered essential of understanding, plus documentation  the person(s) addressing the ICF

         

IRB Requirements: Comply w/ Fed. Regulations.

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: ICF is required prior to HIV testing, unless the subject remains anonymous to the PI & results are not posted to the subject. Persons other than lab staff are required to submit results to DOH. Counseling must be available

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: None Specified

 

Genetic Testing: Genetic testing info may not be disclosed unless used in paternity cases. ICF must be obtained prior to testing

 

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. Coverage is NOT contingent on the insurer providing coverage for prescription drugs in general.

 

Medically Necessary Services: None Specified

 

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.legislature.mi.gov/(S(ca0hkr45tqxxxqr3er34ut3v))/mileg.aspx?page=home

 

 

 

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