January 25, 2019

UVMClick – IBC

For those of you who are not aware, the VP for Research with support from University of Vermont, University of Vermont Medical Center and the Larner College of Medicine purchased a new electronic protocol submission software called Click.  This product is widely used by many institutions like our own and is fast becoming a gold standard. 

The Research Protections Office went live with the IRB human subjects module in November 2018 and we are now moving on to the development and release of the IBC module with a tentative go-live date of April 1, 2019.  There will be no data transferred from the existing InfoEd system as we are using this opportunity to transition to a “Master Protocol Registration” (MPR) model.  We will be starting with a clean slate in the new system which means that researchers will be required to submit all of their current work under the new MPR model.

Master Protocol Registration (MPR)

The move to a MPR process is something that the research community has requested from time to time.  The IBC Committee has been preparing for well over a year.  The Click system allows for one registration to cover multiple projects, therefore we are adopting this model.  This means that researchers will now combine multiple internally- and externally-funded projects under one MPR.  For example, all research projects involving BSL1 and BSL2 work practices will be submitted under one PI’s MPR going forward in the new system.  Projects requiring BSL3 work practices cannot be combined with lower biosafety level registrations. However, if you have more than one BSL3 project, those may potentially be combined.  Additionally, all teaching laboratories utilizing biohazardous materials will be required to submit a MPR describing the work and safe handling procedures being conducted in the teaching laboratory. 

New projects/grants involving agents requiring those same BSL work practices will be added by amendment to an approved MPR.  Hence, the days of submitting one protocol per grant are over.  Going forward there will be one continuing review for each MPR.  This transition will require quite a bit of initial work for researchers, the IBC, and RPO staff. However, once your MPR is approved in the new system, the numbers of subsequent submissions will be substantially reduced. 

Preparations and Logistics

We are reaching out now to allow you time to review your current IBC research portfolio.  Our records indicate that there are many very old protocols that continue to exist in our system that probably should be closed.  Please use this time to think about which activities will continue and submit closures for protocols that are no longer active or needed.

Review of MPRs

The full Committee will be reviewing each of these new MPRs as invariably the combination of multiple protocols/projects will result in necessary changes.  As this will be a new review, this is also your opportunity to not only update your currently approved projects but to make any changes you need to reflect the current state of your research program. All PIs who are leading an active research program involving biohazardous agents will be required to submit a MPR e-application  

We anticipate approximately 80 MPRs will be submitted to our office.  In an effort to effectively manage that number of MPRs, the plan is to identify those PIs who have existing protocols that are due to expire in April and May and reach out to them with a list of their protocols and instructions on how to submit a new MPR e-application.  This does not preclude researchers from submitting their MPR anytime they are ready.  New MPRs will be placed in the queue for Committee review.  Researchers will not be sanctioned for any protocol expirations during this transition period.

Educational Sessions

Educational sessions will begin in March.  Some sessions will be in Waterman and others in HSRF.

Register for an upcoming UVMClick – IBC educational session (opens in a new window).

Ongoing submissions between now and April 

New Protocols

We would prefer that you hold new protocols if possible until after the go-live date, because you will be required essentially to submit a second time sometime after the go-live date.  However, if you require a just-in-time approval, then submit following the current process.

Continuing Review

We will review and complete any protocol continuing reviews that have been received by the office.  We have ceased the continuing review reminders and are administratively extending protocol expirations during this transition period.

Amendments

Any amendments to protocols may be submitted to the office following current procedures up until the go-live date.

After the go-live date, if you have an amendment to an existing protocol, you will need to develop and submit your MPR application, including the new amendment information.  If the amendment is urgent, contact the office as MPRs will be placed in a queue for review by the full Committee.   

Incidents

Any incidents should be submitted following the current process until you have an approved MPR.

Key Personnel

Key personnel changes should continue to be submitted following the current processes until you have an approved MPR.