Institutional Biosafety Committee
December 14, 2009
The Move from Paper to Electronic Exchange of IBC Protocol Materials
Beginning 01/01/2010 the IBC will require investigators to submit all protocols and protocol-related submissions (e.g. continuing review, amendments) in portable document format (PDF). This change is a giant step forward and should result in less paperwork for the investigators and the IBC staff.
We continue to require protocol submissions to be signed by the Biosafety Coordinator and the PI. This will require that investigators scan final submission documents into a PDF document and then forward them to our office. We have identified a potential pitfall with this new process to be confusion with document versions. We must all be vigilant about making sure we are always working with the currently approved version of the protocol form. Please update your documents every time they are submitted by completing the footer with the date of the submission. This date footer is not automatic, therefore you must change it each time you revise your protocol form. You should not use the automatic date feature as this will add further confusion by changing your date every time you happen to open the document. Failure to update this protocol version date may delay review of the submission.
All submissions need to be sent to the IBC@uvm.edu email box where new submissions will be monitored and processed in the order they are received. Electronic submissions prior to January 1 will be accepted.
As you know we have already implemented automated email notifications and correspondence from the InfoEd database system. This will continue without any changes.
Reminder: Depending upon which email software and browser is used, the Infoed correspondence may appear within the email message or as an attachment or both. Investigators may reply to these automated emails, but remember to attach a PDF document(s) of whatever it is that is being submitted for review. Do not attempt to complete an attachment that appears to be automatically generated. You can either print the attachment, complete, and then scan or go to our forms page for a Word version of the form, complete and then scan.
We expect that some adjustments may need to be made to this new process and appreciate your patience and feedback during this transition.
October 30, 2008
October 24, 2008
Changes to Training Grant Internal Review Process
In the past, the RPO Committees (IACUC, IBC, IRBs) have given a single certification of approval for institutional training grants that were awarded to UVM through a process we called “administrative review.” This process was based on the requirement of certain federal sponsor for a single certification that all the individual research protocols named in the institutional training grant application had been reviewed and approved by the appropriate committee. Over the years, we have found that this certification is no longer required.
The research that trainees are involved in changes over the life of a project and any approval is only a “snapshot” in time. What is important to the funding agency is the institution provides assurance that all projects that a trainee will work on have been appropriately reviewed and approved. This assurance does not need to be in the form of a single IRB or IACUC certification of approval.
Because this administrative review activity is no longer necessary we are phasing out single protocols associated with institutional training grants. We will notify individual investigators that they will no longer be required to complete and submit continuing review paperwork and the files will be closed.
Principal investigators of training grants, however, are still required to provide the funding agency with a list of the projects and approval dates that trainees are working on with their annual progress report. The Research Protections Office can assist you with obtaining protocol approval information if you submit a list of protocols with the following information:
Committee File Number (CHRMS/CHRBS,IACUC, IBC), Principal Investigator
Name, and Protocol Title
Please call (656-5040) or email (firstname.lastname@example.org) the Research Protections Office if you have any questions about this change.
INFOED PROPOSAL NUMBERS AND THE CHALLENGE OF MATCHING GRANTS TO PROTOCOLS
Funding agencies generally require review of the specific research procedures outlined in the grant application by the applicable RPO review committee(s). Each protocol submitted to the RPO for review must be linked to the corresponding grant application. This is a requirement for all of the RPO Committees (the IRBs, IACUC and IBC).
A new protocol must be submitted for Committee review and approval for every new funding proposal and every competitive renewal submission.
Pre-award services (PAS) will not release your funds until they have documentation from the applicable Committee that the protocol corresponding to the specific grant application, has received the appropriate clearances from RPO. The task of matching grants to protocols over the years has been extremely difficult because it was done manually and, unfortunately, the system has been less than perfect.
Now, with the implementation of Infoed, the electronic proposal and protocol management system, we are now able to link the protocol to the grant electronically and both PAS and RPO will have access to the corresponding materials. However, in order to link correctly we need your assistance in making the initial identification.
Each of our Committees have revised their protocol submission forms to include a field for the Infoed Proposal Number. We have been piloting this field on the Biosafety Committee forms for six months and have found that a majority of protocols are received with inaccurate or incomplete information. Inaccuracies typically include a proposal number for a proposal in which the project period has already ended or for a project that was never funded.
We wanted to take this opportunity to remind you of this requirement and to assist you in becoming familiar with this very important number. Below is a copy of routing form with the Infoed Proposal ID Number circled. This is the required number for all initial and continuing review forms.
Going forward, we will not be able to enter protocols submitted to the RPO committees into the Infoed management system without the correct information, and review of the protocols may be delayed.
It is critical that you identify the correct grant application and indicate the Infoed Proposal Number from the routing form that corresponds to the protocol you are submitting. If there is any uncertainty, please contact a staff member from either PAS or the RPO to assist you in determining the appropriate Infoed proposal number. Ultimately, this will make the entire process much smoother for everyone.
As indicated in our October 6 memo, the recent change to the protocol review process requires the completion of a Risk Assessment by UVM's Environmental Safety Office prior to protocol review by the Committee. During this transition period we have allowed some new protocols to be included on an agenda without this Risk Assessment in place.
As of January 1,
we will fully implement our new procedures and will no longer review new protocols
without completion of this Risk Assessment. Researchers need to make an appointment
with the Biosafety Coordinator, Jeff Labossiere, as soon as they have a draft
of the protocol. This will allow time for a site visit and determination of
review type prior to the IBC submission deadline. To assist you with these timelines,
review the submission timelines on the forms page.Biosafety Program Coordinator
Jeff Labosierre (656-5400 or email@example.com)
Thank you for your continued cooperation as we implement this process. If you have questions or need help, please call or email Kim.Wood@uvm.edu.
Last modified December 09 2009 09:45 AM