Announcements

New IRB-HSR Chair
Effective August 1, 2009, Dr. Richard D. Stevenson will become the new chair of the IRB-HSR.  Dr. Stevenson is a professor in the Department of Pediatrics. He has been a member of the IRB-HSR for the last 6 years.  Please join us in welcoming him into his new position as chair.  We would also like to take this opportunity to thank Dr. Karen Schwenzer, who has chaired the IRB-HSR for the last 6 years, in addition to having been a member for a total of 12 years.  Her contributions to the IRB-HSR will have a positive impact on this board for years to come.

Copies
The IRB-HSR office has been swamped with requests for copies.  We are currently receiving about 30-40 a week.  Unfortunately, when we spend much of our time making copies, there is little time left to review your submissions.  We need to ask that you either check with other people on the study team to find the copies you need or call the IRB office at 243-7039 or 924-5152 to make an appointment to come over and make the copies you need.

CITI Online Training to be down
The online CITI training will be down for servicing the first week of August. If a new member of your study team needs to complete CITI training in the near future, we recommend they complete the training prior to August 1st.

New Guidance on Aggregate Review
The IRB-HSR has added new information to our website regarding an explanation on how to carry out an aggregate review of your study data.  This information is required to complete the continuation status form.  The new information may be found at
http://www.virginia.edu/vpr/irb/hsr/continuations.html#aggreview

New Learning Shots
Two additional learning shots have been developed and are now posted.

IRB-Online describes the wealth of information that is available to the study team regarding their protocols in IRB Online. http://www.virginia.edu/vpr/irb/learningshots/IRBonline_Jun09/player.html

Writing a Clinical Research Protocol provides important information to consider when developing a research project and writing the protocol. 
http://www.virginia.edu/vpr/irb/learningshots/Writing_protocol_June09/player.html

IRB-HSR 101 Class Dates
Additional dates for the IRB-HSR 101:" A short course for Study Coordinators and Sub-Investigators of Clinical Research have been set for 8:30- 12:00 AM on  
-Monday, September 21st
-Wednesday, October 28th
If interested in attending please contact Jean Gaare Eby at jmg5b@virginia.edu

Protocol Builder Update
Several new questions have been added to Protocol Builder  regarding Waiver of Consent and Waiver of Documentation of Consent.  New questions were added in order to make sure the correct templates are being inserted into the protocol for all the different possible combinations of no consent, verbal consent and written consent involved in the consenting process. Additional guidance has also been developed to help you answer the new questions.  PLEASE review the guidance found in Protocol Builder before answering the new questions. 

Auxiliary Documents Required for Submission
In the past the IRB-HSR has allowed certain items like the New Medical Device Form or the Radiation Safety Committee Approval to be submitted after the Agenda Submission Deadline.  As the process for these items has been improved, the IRB-HSR has found that in some cases, the outstanding item is the ONLY thing preventing the full board from approving a protocol.  Therefore, the Protocol Cover Sheet now states that these items will be required at the time of the agenda deadline submission along with the protocol.

Need Any Clips? 
The IRB-HSR has a large box full of all different sizes of black clips.
FREE- First Come- First Serve-
Contact Florence Thoms at fgt@virginia.edu if interested.

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