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Last modified March 2, 2009.

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Pennsylvania

State Legal Structure: Comply w/ Fed. Regulations

 

Required Notification to State Officials: Any CT involving NC mental health patients, a protocol must be submitted to the Deputy Secretary of Mental Health

         

Protocol Requirements: Comply w/ Fed. Regulations

 

Legal Rep. Standards: Parents are guardians for their children. Incompetent persons, no on may consent, PI must have a court order

         

Age of Consent: 18-or High school graduate, a parent, or married

         

Informed Consent Requirements: Copies of the 45 CFR 46 must be made available to individuals considering enrollment in a CT

         

IRB Requirements: Comply w/ Fed. Regulations

         

Special Rules for Cancer Research: None Specified

         

HIV/AIDS Testing: IRB approved research does NOT require ICF and pre-test counseling prior to HIV testing. Please see 35 PS 7605 (f). ICF required before disclosure. Counseling must be available

 

Payments to Subjects: None Specified

         

Drug Supply Requirements: None Specified

 

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://www.pacode.com/

&

http://members.aol.com/StatutesPa/Index.html

 

 

Last Updated ( Wednesday, 16 September 2015 14:37 )