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Working With the IRB-HSR

Getting Started Protocol Review Process

Managing Protocol After Initial Approval Special Issues

 

You can find out when your protocols are due for continuation review by logging into IRB Online and clicking on IRB Schedule. It is up to you to submit the IRB Status Forms on time or your IRB approval will expire.

Announcements

IRB-HSR Holiday Office Hours (December 2013)
The IRB-HSR Office will be closed on Holiday days according to the UVa acedemic calendar:
12/24/13, 12/25/13, 12/26/13, 12/31/13, and 01/01/14.

Consent Form Issues (February 2013)
The IRB-HSR has modified its policy regarding consents in medical records.  You are now required to send the signed consent form to medical records ONLY if the study involves research of a drug, device or biologic, or involves an intervention that might significantly affect the clinical care of the subject.

Privacy Plan Issues (February 2013)
The template for the Privacy plan found in the IRB-HSR protocol has been modified to allow the study team to FAX identifiable info to the sponsor under certain conditions-  
FAXING outside of UVa is only allowed if the receiving fax machine is in a restricted-access location, the intended recipient is clearly indicated, and that recipient has been alerted to the pending transmission and is available to pick it up immediately.  Also verify FAX numbers before faxing and use FAX cover sheet with a confidentiality statement.

Study Documents (February 2013)
Please note that adding, deleting or revising things like questionnaires, is considered a modification.  The IRB-HSR cannot process them through a Receipt of Acknowledgement process. 

IRB 101 Class (February 2013)
Beginning in 2013 the IRB 101 class has been updated.  Along with the previous topics, the session will now include information on data security, the pre-review process, the IRB Website and IRB Online.  
Contact Jean Gaare- Eby at jmg5b@virginia.edu to register.

NEW:  IRB 201 Class (February 2013)
Beginning in 2013, the IRB-HSR will offer a new class: IRB 201.  This class will cover topics including modifications and continuations. 
Contact Jean Gaare- Eby at jmg5b@virginia.edu to register.

NEW Class Offering:  (February 2013)
The Office of the Vice-President for Research and the Department of Public Health Sciences are pleased to announce a new course offering for Spring Semester 2013: Methodology, Ethics, and Regulations of Research Involving Human Subjects
For more information at http://www.virginia.edu/vpr/irb/hsr/education_inperson.html
 CME credits offered.



(Posted 02/22/2013)
(Revised 04/09/2013)

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