A survey into the implementation of commercial Institutional Review Boards (IRBs) at Thomas Jefferson University and their impact on the workload of the local IRB. Lediona Mehmeti, MS July 2018 Master of Science Clerkship Mentors: Kyle Conner, MA, CIP, Walter Kraft, MD

Two Approaches Looking at the numbers -JeffTrial -In-office Excel spreadsheets Gathering feedback from research coordinators -Detailed questionnaire -7 approached, 6 responded

Looking at the Numbers Table & Graph 1: Number of studies that were pre-approved and authorized for submission to cIRBs by Jefferson IRBs. Table & Graph 2: Number of active protocols and commercial reviews by year. Obtained from JeffTrial database, IRB control numbers.

Research Coordinator Feedback 62% believe that workload has been significantly reduced 83% say that there is more time for them to dedicate to other projects All of them would like to continue working with cIRBs in the future 83% say that Jefferson facilitates the process for reviews by cIRBs 83% of them find cIRBs to be more efficient than local IRB 63% of them believe that the turnaround time from cIRBs is shorter 50% agree that due to working with cIRBs, volume of studies has increased for their respective departments Figure 5: Graphical presentation of number of studies submitted by each individual coordinator to cIRBs.

Further Comments from Coordinators Many sponsors favor submission to central/commercial IRB. Jefferson is a preferred institution to work with because it can submit to most cIRBs. While most sponsors prefer working with cIRBs, others will only work with cIRBS. Commercial sponsors are always impressed and pleased that Jefferson is able to work with cIRBs as it allows Jefferson coordinators to shorten the activation time. Working with cIRBs has also reduced the workload for submitting protocols and informed consent amendments because the sponsor in most cases submits to the cIRB directly, on behalf of all the study sites. It is easier to add key personnel, especially when working with WIRB, since CITI (Collaborative Institutional Training Initiative) training is not regulated by cIRBs. 50% of the coordinators feel that it is better to learn and understand the IRB process through a local IRB.

Concerns Delays: with cIRBs, it can be a few days before questions and concerns can be addressed. -Jefferson IRB is better at communicating and easier to get a response from. Dynamic environment: constant mergers occurring, cIRBs tend to not communicate the changes made in a timely manner. -Example: Jefferson has an agreement with Schulman, which recently merged with Chesapeake and it is not quite clear if submissions should still go to Schulman Communication: cIRBs, specifically WIRB, will submit study amendments on the coordinators’ behalf without making them aware of the changes. -Research coordinators become aware of these changes only when they receive the approvals from the cIRB. -Their preference is to the have all study sponsors contact the study site before an amendment is submitted without the approval and review, as sometimes amendments change the study contract and budget.

Requests to cIRBs for comments The three preferred commercial IRBs by Jefferson were contacted for comments Only Schulman, now doing business as Advarra responded to the information request Depending on the type of review, protocols can get a contingent or full approval within 5 business days of a full submission Sites participating in a multi-site sponsored trial receive decisions in as early as 24 to 48 hours While the cIRB did not provide specific figures regarding approval rates, the majority of studies are approved The few that do not receive immediate, full approval receive feedback from the cIRB and after making the necessary changes are eventually approved. Studies that do not wish to make the recommended changes generally tend to withdraw from the process.

Conclusions Purpose: look at the implementation of cIRBs at TJU and assess their impact on local IRB and clinical research personnel. Survey found similarities to a nation-wide trend: cIRB use is on the rise. Attitude of research coordinators is generally positive when dealing with cIRB. cIRBs have showed increase in efficacy and ease of operation. Room for improvement in terms of communication

Thank you! Questions?