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IRB-HSR > Managing Protocol After Initial Approval > Informed Consent > Maintenance of Informed Consent Documentation

 

 

 

 

 

 

Maintenance of Informed Consent Documentation

Principal Investigators are responsible for maintaining original copies of consent/authorization forms signed by subjects, in a secure location, for at least six (6) years following completion of the research and longer, if required by the funding source or sponsor. A copy of an informed consent document for particular treatments or procedures shall be placed in the subject's medical record in accordance with Virginia state and local government regulations.

 

In cases where Principal Investigators transfer their research programs to other institutions, the disposition of consent/authorization forms must be discussed with the IRB administrative staff.

 

*Taken from UVa IRB-HSR Research Guidance