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Oregon

State Legal Structure: Comply w/ Fed. Regulations. Prisoners can NOT participate in any research

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: A health care rep (guardian) possess all the authority only when the subject is incapable

         

Age of Consent: 18-minors who are 15+ or married, or who have been emancipated

         

Informed Consent Requirements: Comply w/ Fed. Regulations

         

IRB Requirements: Comply w/ Fed. Regulations

         

Special Rules for Cancer Research: OR maintains a cancer registry. PI's may access this database by submitting their protocol to the OR DOH for approval

         

HIV/AIDS Testing: Written ICF MUST be obtained before testing may occur

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: Hospital pharmacies must store & dispense investigational Rx & maintain all info regarding those Rx within the pharmacy

 

Genetic Testing: Written ICF is required before testing or info can be gathered, PHI is not disclosed or is coded. Penalties for non-compliance

 

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: Have enacted off-label drug use laws that do not explicitly address cancer treatment, instead they refer to life-threatening conditions or generic off-label indications

Medically Necessary Services: None Specified

 

Experimental or Contraindicated Rx NOT Covered: None Specified

         

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

         

State Codes & Links:

All codes can be found at

http://www.leg.state.or.us/ors/home.html

&

http://arcweb.sos.state.or.us/banners/rules.htm

 

 

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