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Welcome

Welcome to the website for the Institutional Review Board for Health Sciences Research (IRB-HSR) at the University of Virginia (UVa). The IRB-HSR is responsible for reviewing all medically related research involving human subjects conducted by UVa faculty, employees and students. 

The IRB-HSR also serves as the HIPAA Privacy Board for research involving Protected Health Information (PHI).


Working With the IRB-HSR

Getting Started Protocol Review Process

Managing Protocol After Initial Approval Special Issues




The IRB-HSR Website now has a search feature which allows you to search for information on this site. To use, click on “SEARCH THIS SITE” in top left hand corner.

 

 

 

 

 

 


Announcements

IRB-HSR Website Search Feature (Posted April 2015)
The IRB-HSR Website now comes with a “Search this Site”  option- top left hand corner.

Coded and Non-engaged Applications (Posted April 2015)
The signatures in the agreements in the Coded and Non-engaged Applications have been eliminated.  All signatures required on agreements/ contracts will be handled by the SOM Grants and Contracts Office/ OSP with the Material Transfer Agreement.

Sharing Identifiable Data outside of UVa for an Improvement Project?   (Posted April 2015)
If you will be sharing identifiable data outside of UVa for an Improvement Project- you MUST submit The Determination of Human Subjects Research form to the IRB-HSR.
http://www.virginia.edu/vpr/irb/HSR_docs/Forms/Determination_of_Human_Subjects_Research.doc

5 Year Updates (Posted April 2015)
If a protocol is Open to Enrollment and the 5 year update is not completed the IRB approval will expire.   Five-year updates will now also be required for Database Protocols. 

VPN Required to Access IRB Online/ Protocol Builder if Off Grounds (Posted April 2015)
For added security a VPN is now required to access IRB Online/ Protocol Builder if you are physically off grounds.
 
ISPRO Approval (Posted April 2015)
As we have found situations where the changes required by ISPRO have required alterations in the protocol the ISPRO approval will now be required at the time of the protocol submission for pre-review to the IRB.

Expiration Dates on Certificates of Confidentiality (Posted April 2015)

If you have a protocol which has a Certificate of Confidentiality granted by the NIH, you should be aware that the Certificate has an expiration date.  If an updated Certificate is not submitted the IRB approval will expire. If your protocol has an IND or IDE, the Certificate will expire with the IND or IDE. 


(Last update 04/01/2015)

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