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Last modified March 2, 2009.

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Iowa

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: None Specified

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Guardians, Spouses, adult children, parents, adult siblings, & POA

         

Age of Consent: 18-Married minors may consent. Under 18 but who was tried, convicted, & sentenced as an adult may consent

         

Informed Consent Requirements: Comply w/ Fed. Regulations

         

IRB Requirements: Comply w/ Fed. Regulations

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: See Iowa Admin Code §641.11.29 (141) Written ICF is MUST be obtained before testing can occur. Counseling must be available

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: IND Must be on file 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: None Specified

         

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://coolice.legis.state.ia.us/Cool-ICE/default.asp?category=billinfo&service=IowaCode

 

Administrative Codes can be found at

http://www.legis.state.ia.us/IAC.html

 

 

Last Updated ( Wednesday, 16 September 2015 14:44 )