January 12, 2017
Posed to: John Kantner, Assistant Vice President , ORSP & Dean of the Graduate School
The sluggish pace at which ORSP’s Research Integrity division and the IRB process research protocols existed with former director Dr. Ebong and continues to this day. This has become for many of us a serious hindrance to advancing our research agendas. When should we expect a real change in the speed at which IRB completes this work, and how do you plan to clear the backlog of review requests in an expeditious manner?
I appreciate the Faculty Association providing me an opportunity to respond to the inquiry regarding the challenges that the UNF community has had in getting human subjects research protocols approved by the Institutional Review Board (IRB) in a timely manner.
First, it’s important to acknowledge the factors that drive human subjects research compliance. UNF is obligated to the federal regulations encoded in the US Department of Health and Human Services 45 CFR 46—generally known as the “Common Rule.” These require that we maintain an independent IRB with operating procedures that locally govern human subjects research but that carry the weight of federal regulation. To ensure that the university is in compliance, the IRB’s records and the human subjects research activities of the university are subject to federal audit.
UNF traditionally maintained a strongly compliant—some might say overly conservative—set of operating procedures. This included oversight responsibilities that in some ways went beyond what was required by regulation, but that at the time were considered to be in the best interests of the institution and the conduct of ethical research. Another component of the operating procedures was heavy reliance on well-trained staff to advise and support the IRB members. This combination of expansive oversight and intensive staff involvement was neither scalable nor resilient, and this became painfully apparent as UNF’s research portfolio grew.
In 2013, the IRB, then under the chairship of Krista Paulsen and more recently Jennifer Wesely, launched an extensive review and reworking of many sections of its operating procedures, with an eye to streamlining protocol processing and approval. The chairs and IRB members spearheaded numerous important changes, the results of which had significant impact: while in late 2013, it took almost 40 days on average for exempt approval, by early 2016, that was down to around 10 days, close to the national benchmark for IRB turnaround on exempt protocols.
Unfortunately, Spring 2016 saw a perfect storm that set progress back significantly. First, the one staff member fully dedicated to supporting the IRB left in the midst of a UNF hiring freeze. At the same time, multiple noncompliance cases were reported that by regulation required staff investigation. And this occurred right when new research- and practice-based graduate programs were launching. The result, as everyone knows, was that the IRB’s operations virtually ground to a halt and a sizable backlog built up.
I want to make it clear that I take responsibility for the resulting crisis. The IRB chair, committee members, and staff have worked incredibly hard to process protocols and expedite changes to the operating procedures within the regulatory limits. But I’m responsible for the staffing, and I had knowingly accepted the risk of such a crisis by deploying ORSP resources for other purposes. I had also intentionally postponed implementing important procedural changes designed to expedite processing of non-exempt protocols, because long-anticipated federal regulatory changes were thought to be imminent and would need to be integrated into our systems; I didn’t want to keep making procedural changes at the risk of causing confusion and further slowing processing. Unfortunately, the feds kept postponing changing the Common Rule, and those are currently in limbo during the transition of leadership in Washington DC.
The good news is that when the crisis hit, we quickly moved forward to replace departing staff, implement the postponed procedural changes, and triage the substantial backlog. As a result, the timeline for securing approval of human subjects research through the IRB has improved dramatically over the past two months. As we enter 2017, the new procedures are in place, the backlog is almost clear, and the turnaround on complete and compliant protocols is measured in days—not weeks and months. I apologize for my strategic missteps in 2016 that contributed to the major slowdown, but I’m confident that it will be much, much faster in 2017 to get IRB approval for human subjects research at UNF.