Insights to Inspire: 4 Strategies for Improving IRB Turnaround Times
For many Clinical and Translational Science Award (CTSA) Program hubs, delays in Institutional Review Board (IRB) approval can feel like a translational roadblock on scientists’ path to implementing research that may ultimately improve public health outcomes. However, as an essential part of ensuring the welfare of human research subjects, the IRB is crucial to maintaining the highest ethical standards in research. If hubs take the necessary steps to address researchers’ pain points within their IRB approval process, they will be better positioned to realize goals for improvement and increase the effectiveness of the CTSA Program consortium overall.
In order to maximize the consortium’s impact, NCATS has implemented the Common Metrics Initiative (CMI). The vision for NCATS' CMI is to use specific, common metrics to demonstrate and improve the impact of the CTSA Program. The CMI uses this set of metrics to help focus network and hub activities on making significant, measurable improvements in translational science and research, and workforce development.
Included in this set of metrics is the IRB Common Metric. This assesses the median number of calendar days from the date an application is received by the IRB to the date it is officially approved. In 2019, the Common Metrics Initiative released a Multi-Year Report that identifies the hubs with the most improvement in each of the three metrics for the measurement period of 2016-2017. For the IRB Common Metric, the University of Texas Medical College Branch (UTMB) Galveston and the University of Massachusetts Medical School (UMMS) were among the hubs with the greatest improvement in that period. Both institutions implemented several unique strategies to transform their IRB turnaround times and deliver an improved IRB common metric. Their strategies include:
1. Encourage education and awareness
In an effort to improve application turnaround times and overall efficiency, the UMMS IRB office and Center for Clinical and Translational Science (CCTS) teamed up to take a hard look at their approach to education. What they found was that the group training sessions they were using to educate investigators on how to work with the IRB were poorly attended, ineffective and left investigators with many questions about their specific research projects.
To address this, the IRB office implemented “Ask an Expert” sessions where investigators can sit one-on-one with IRB staff members to ask questions and get advice. These “Ask an Expert” sessions provide a personalized, proactive approach to educating investigators on what is needed to receive IRB approval, ensuring investigators are headed down the right path early in the process rather than making corrections after they are already headed down the wrong path. The IRB team at UMMS also drove education and awareness by developing a self-service “Getting Started” webpage and by gaining a presence at new faculty orientation where they were able to briefly introduce the board members, give an overview on how to work with the IRB and allow people to ask questions. This planted the seed with new investigators about the role of the IRB at UMMS. UMMS’ CCTS played a key role in garnering the necessary institutional support to drive these changes.
2. More meetings make for more opportunities
As the IRB office and the Institute for Translational Science at UTMB Galveston looked to make improvements to their IRB application process, their focus was on increasing opportunities for approval. Prior to 2016, the UTMB IRB only met once a month. In 2016, UTMB Galveston doubled that frequency to two IRB meetings twice a month. This small scheduling change packed a big punch. By doubling the frequency of the meetings, UTMB Galveston created more opportunities for investigators to gain feedback, make corrections and resubmit quickly, if their first submission was not accepted.
“Our mindset is that the IRB office should work with investigators, we shouldn’t be an obstacle,” said Gwen Baillargeon, Senior Biostatistician, UTMB Galveston. “When meetings were only once a month, we stood in the way of investigators completing their research. Now, instead of having to wait a full 30 days before their submission can be reviewed again, investigators now only have to wait two weeks.”
3. Invest in your workforce
One of the biggest challenges for UMMS’ IRB office was finding and retaining skilled IRB staff members. In the competitive Boston-area market, IRB experience is in high demand and the UMMS team found that they were frequently losing talented people to other institutions. The IRB office mitigated this rate of attrition by making two key changes. First, they worked with their HR department to add a rung to the career ladder. This created a place for employees to move up to once they were hired, thus creating more motivation for them to stay and continue to improve their skills. Second, the office did an in-depth assessment of their workforce and made changes to ensure they had the right number of people with the right skills in place. “By ensuring that we had the correct quantity of team members with the skills necessary to be successful in their position, we were able to decrease employee burnout by more evenly distributing workload,” said Allison Blodgett, IRB Director, UMMS.
UMMS also addressed the challenges they were experiencing in filling IRB leadership positions by putting a mentorship program in place. Through this program selected members of the committee were brought in on leadership tasks to groom them to run a meeting in the event that the chair/vice chair was absent or to fill in if one of the chairs stepped down. This gave committee members opportunities to learn and grow while ensuring little to no downtime in IRB operations in the event of a leadership transition.
4. Change your reputation
Both UMMS and UTMB Galveston emphasize the importance of generating an internal change in mindset within the IRB office and an external change in reputation. Instead of fostering a reputation that the IRB office is difficult to work with and a hurdle to overcome, these hubs made a conscious effort to streamline processes and make working with the IRB as easy as possible. For UTMB Galveston, the chief complaint that the IRB office received in 2012 was that investigators couldn’t get any answers. The staff had gotten into the habit of saying no without providing any explanation or feedback on rejected applications. “Now we have the mindset of a customer service department,” said Baillargeon. “By holding ourselves to a higher standard when interacting with investigators we were able to transform the reputation of our office to one investigators want to work with.”
By measuring and tracking changes in IRB turnaround times, IRB offices are able to identify areas that need improvement and take the necessary steps to change. The good news is that IRB offices and CTSA Program hubs don’t have to do it alone. They can gain insight and inspiration about how to bring about transformational changes by collaborating with and learning from other CTSA Program hubs.