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Ohio

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: A wife & husband are the joint natural guardians. If parents live apart the court may award guardianship to either parent

         

Age of Consent: 18-minors, 14+ may consent to mental health treatment

         

Informed Consent Requirements: If a child is to participate in a more than minimal risk study, both parents must sign ICF. If subject says no to treatment it is the final say

         

IRB Requirements: Must include minority group representation in the same proportion of the study population

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: ICF, written or oral, must include: explanation of the test, purpose, potential uses, voluntary nature of the test, & meaning of results. ICF is required before disclosure can occur. Counseling must be available

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: Must be labeled "For Investigational Use Only"

 

Genetic Testing: None Specified

 

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: Has off-label drug use laws that address both cancer & specific use in generic use

 

Medically Necessary Services: Medically Necessary Services Covered

 

Experimental or Contraindicated Rx NOT Covered: Experimental &/or Contraindicated Rx NOT Covered

         

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

         

State Codes & Links:

All codes can be found at

http://codes.ohio.gov/oac

&

http://codes.ohio.gov/orc

 

 

Last Updated ( Wednesday, 16 September 2015 14:38 )