Announcements Archive

Education
Several new learning shots have been posted to the website.

See Inperson Education page for next inperson training class dates.
(Removed 05/30/09)

Modification Update
Please remember that modifications requiring a change to the protocol and/or consent now require a pre-review.  Do not submit hard copies of your modification documents until you have received notification that your pre-review is complete.

Certain changes to a protocol will affect the templates you should use for the protocol and or consent.  For this reason- the full templates are now found on the website.  CAUTION:  These templates should ONLY be used for modifications to protocols already approved by the IRB.  A researcher must use Protocol Builder to write a new protocol or to complete the 5 year update.
(Removed 05/30/09)

Continuation Review Dates
Have a question about when your protocol is due for continuation review? The next review date may be found by logging into IRB Online and clicking on IRB Schedule (Removed 05/30/09

Did You Know A Protocol Violation is any unapproved deviation from the protocol, GCPs, or IRB policies whether or not it is intentional and whether or not it is under the control of the Investigator. (Removed 12/12/08)

Did You Know Unless approved by the IRB, study subjects must provide the study team with a SS# or TIN #(Tax ID Number) or they cannot be compensated for being in the study (cash or gift card). They may enroll, but may not be paid. (Removed 08/18/08)

! Decrease in Number of Copies Needed to SIX! The IRB-HSR is now sharing many documents with IRB members electronically. Therefore the number of copies needed from the research team is decreasing. The number of hard copies needed for protocol and grant submissions has decreased from 23 to 6. (Removed from Main Page on 8/6/08.)

! Modifications and Continuation Status Reports: Modifications may no longer be submitted with a continuation status report. Modifications must be submitted separately. The only exception to this is a change in personnel. Please see the modification process page for additional information on how to submit a modification. (Removed from Main Page on 8/6/08.)

! Investigator Agreements: The IRB-HSR now requires the signed Investigator Agreement to be submitted to the IRB with the initial submission. If there is a problem in obtaining signatures from the Department Chair prior to the submission deadline the IRB staff will work with the study team on a case by case basis to obtain the signatures. (Removed from Main Page on 8/6/08.)

! Caution: Keep in mind that any data or documents, such as your research data, protocols or consents stored on the C-drive of your computer will not be backed up unless you do it yourself. For this reason the IRB does not advise files be stored on the C-drive. (Removed from Main Page on 8/6/08.)

The pre-review process has been so helpful that the IRB-HSR is requiring the same process for Expedited Studies. Please see the new instruction in Protocol Builder for assistance.

HSR Full Board Pre-Review Deadlines: The IRB-HSR is now accepting pre-review applications on a continuous basis and the pre-review is no longer subject to deadlines.  Please note that all protocols must be pre-reviewed before they can be included in a full board meeting. Allow for at least 7 business days for the pre-review process.  Please see HSR protocol submission for more information. (Removed from IRB Homepage 1/11/08)

IRB Coordinator Designation: Individuals other than IRB Coordinators hired by the IRB may now be designated as the IRB coordinator in Protocol Builder.  This person will receive emails regarding the protocol along with the PI, Study Coordinators and Department Contact.  (8/06) (Removed from IRB Homepage 1/11/08)

The IRB-HSR has a brand new SOP on Violations and Protocol Enrollment Exceptions. Read the new SOP (Removed from IRB Homepage 1/11/08)

Notice Regarding IRB-HSR Protocol Builder Program:
The IRB-HSR is currently in the process of making improvements to protocol builder. These improvements may affect you only if

1. you are in the process of answering the questions and have not yet downloaded your protocol and consent form templates or
2. if you need to go back and change answers to questions and re-create the templates.

Prior to creating your templates click on "Check Progress." 
You may receive a message of "Sequence Incomplete" next to "Questions."
If this happens please take the following steps to remedy this situation:

1. Click on Questions. 
2. Start with question # 1 and go through the questions consecutively - answering each question in order. 
3. If the question is already answered - all you need to do is hit the enter button and go onto the next question. 
4. This process will reset the program and allow you to print the templates when you click on Create Forms.

This process should take you no longer than 5 minutes to complete.  We apologize for the inconvenience. Unfortunately, there is no other way to make these upgrades.  Thank you for your attention to this issue. (01/11/08)
(Removed 01/29/08)


Protocol Builder Assistance:
The staff of the IRB-HSR provides assistance with Protocol Builder at no charge. If you are using Protocol Builder and need assistance please contact Margaret Ball at mnw2h@virginia.edu or 243-0639. (Removed 01/29/08)

Notice Regarding IRB-HSR Protocol Builder Program:
The IRB-HSR is currently in the process of making improvements to protocol builder. If you are having trouble creating your templates please review.

Changes to Modification Process
The IRB-HSR is happy to announce changes to the modification process.  Several things such as personnel changes (other than PI), minimal changes in # of subjects, and most change of status may now be done electronically.

In addition, any type of modification made to the protocol and consent form must be submitted initially electronically for pre-review.  As with pre-review for other submissions we have found that this actually saves many steps back and forth with hard copies. 

The new process is now posted on the IRB Website under "Maintaining a Protocol.  The   revised forms are now posted under "Forms".  Please throw away any copies of outdated modification forms you may have saved on your PC or in hard copy.
http://www.virginia.edu/vprgs/irb/hsr_maintain_modification.html

Studies Involving Drugs, Biologics and Devices
The IRB-HSR has added more information to the website regarding FDA information and IRB processes for studies involving drugs, biologics or devices. Please see http://www.virginia.edu/vprgs/irb/hsr_polproc.html

New "learning shot" presentations available online
Three new voiced-over presentations have been added to the IRB's website.  The new presentations cover the process for modifying an approved protocol, use of consent "short forms" for non-English speaking research participants, and how HIPAA can impact the research recruitment and advertising process. These talks can be viewed at http://www.virginia.edu/vprgs/irb/education_online.html

Studies Involving Gene Transfer
The School of Medicine has updated their Gene Transfer Policy.  It is now posted on the IRB-HSR website http://www.virginia.edu/vprgs/irb/HSR_docs/Forms/Gene_Transfer_1-25-08.pdf
(Removed 04/04/08)