Re-envisioning the IRB Program for Penn State

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Office for Research Protections     |     Institutional Review Board      

The Office for Research Protections is pleased to announce its re-envisioning of the IRB programs at University Park and the College of Medicine into a centralized program with a new organizational structure and additional resources.  The transition, now underway, unifies the University Park-based IRB program and the College of Medicine’s Human Subjects Protection Office into the Human Research Protection Program for the University.

This re-envisioning combines the expertise of both IRB office locations to form a strengthened and comprehensive Human Research Protection Program.  According to Candice Yekel, associate vice president for research, “We know there are differences between campuses, hospitals, and colleges; this transformation allows us to unite our expertise while maintaining local context.  We’ll have more consistent reviews for the University, and we’ll be able to develop and implement a Single IRB reliance program.”

University leadership has also committed to hiring new positions for the Human Research Protection Program.  “We’re aware that review timelines are lengthy right now.  With the addition of new positions on the team, we will improve our efficiency.  Our hiring process is just starting, but researchers should start to see shortened review timelines later in 2021,” Yekel said. 

Among the other changes coming in 2021 are new review teams (one for full board studies and one for expedited/exempt reviews); more frequent but shorter board meetings; and the addition of a team focused on Single IRB reliance and regulatory support.  Rachel Lally will assume the position of Executive Director of the Human Research Protection Program.  “These are all important steps for us to support our growing research enterprise. The pandemic demonstrated our ability to unite while working remotely, and I’m excited that this transformation brings us in-line with other leading research institutions,” Lally said.  Sara Horn will be the IRB Director overseeing both review teams, which will be led by the current assistant directors.  Staff are already working together on improving the consistency of reviews and processes.  

Researchers may have a change of IRB analyst in the months ahead but use of the CATS IRB system will not be changing.  Upgrades to CATS IRB are also expected in 2021.  Researchers will be notified in advance of any changes that may impact them.

Yekel said, “The Human Research Protection Program fulfills University leadership’s goal of one University program.  It will be a transition, but the end goal is improved review times and smoother processes down the road.  This is a true re-envisioning of our programs and our work.”