IRB-HSR Home Institutional Review Board for Health Sciences Research
Researchers IRB Members Research Subjects IRB STaff







+ Calendars & Deadlines
+ Office Information
+ Directions & Hours
+ Staff Directory
+ Frequently Asked Questions
+ IRB-HSR Membership Lists
+ FWA Information
+ Organizational Charts
+ Research Concerns
+ Standard Operating Procedures
+ Getting Started
+ Protocol Review Process
+ Managing Protocol After Initial Approval
+ Special Issues
+ Protocol Builder and IRB On-Line: On Grounds or UVa VPN access only
+ Forms
+ CITI Training
+ Education
+ Regulations/Guidelines
+ Ethical Principles
+ Search IRB-HSR Protocols
+ Glossary/Acronyms
+ Useful Websites
+ Go to full list >>


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