Published September 1, 2021
The University at Buffalo Clinical and Translational Science Institute (CTSI) is launching a new section in its two-times-per-month Translational Spotlight newsletter, one designed to share the latest news and updates from UB’s Institutional Review Board (IRB) and Clinical Research Office (CRO) with researchers.
The “Research Roundtable” section will make its debut in the September 15 issue of Translational Spotlight and will run whenever the IRB and CRO have news to share.
“‘Research Roundtable’ will provide our clinical research teams with timely and accurate updates on guidelines and requirements that will speed up clinical trial start-up and make the process less burdensome,” says CTSI Director Timothy F. Murphy, MD. “Regulations and forms change regularly due to changing national requirements. The CTSI, the IRB, and the CRO will work together on this section to help keep research teams up to date to help streamline their work.”
Richard Karalus, PhD, UB’s Director of Research Compliance, sees “Research Roundtable” as a new way for the IRB and CRO to connect directly with researchers.
“I see the new section as offering our investigators clearer guidance on both the process of submitting research studies and the interpretation and application of research regulations and guidelines in their studies,” he says.
Clinical Research Office and CTSI Associate Director Sanjay Sethi, MD, adds that the complexity of regulations makes staying informed very important, but also very difficult.
“Regulations governing clinical and translational research, especially when it involves human participants, are complex and ever-changing,” Sethi notes. “Adherence to these regulations is important and necessary to conduct high quality, reliable, and responsible research. Navigating these regulations and staying abreast of changes are challenging for even experienced researchers.”
Sethi, Murphy, and Karalus agree that an increase in communication from the IRB and CRO can only benefit UB researchers.
“Investigators are frequently unsure how they should be interpreting the regulations, and how the UB IRB applies those regulations to a research study,” Karalus explains. “In many cases, the regulations are not written in clear language, and are left for the IRB to interpret and apply. Therefore, if investigators are made aware of IRB interpretation and application, they can more quickly and easily apply them to their studies for timely approval.”
Murphy adds that “staying up-to-date on changing regulatory requirements will avoid unnecessary delays in the start-up and in the conduct of clinical trials. We are hoping that by enhancing communication, the entire process of clinical trials will be more efficient and more rewarding for our research teams.”
He believes the review process may run more smoothly, as well. “The IRB and the CRO will benefit by receiving well-prepared proposals and protocols, accelerating review and approval.”
Sethi says research offices at UB — specifically the IRB, CRO, and Sponsored Projects Services (SPS) — exist in order to enable research teams to be compliant with regulations and to keep them well informed of new developments.
“‘Research Roundtable’ will form a single channel of communication for these offices to disseminate in a timely manner relevant information about the practical aspects of conducting research at UB, with an emphasis on contemporaneous changes,” Sethi explains. “Having well informed research teams, in turn, makes it easier for the research offices to conduct their responsibilities, which should lead to increased efficacy and efficiency of our research efforts.”
Watch for the debut of “Research Roundtable” in the September 15 issue of Translational Spotlight. Add your email to the newsletter mailing list here.