Open Research Office bridges gap between clinical researchers and regulators

Sarah Reilly.

Published May 1, 2018

A diverse group of clinical and behavioral investigators and research coordinators came to UB’s South Campus in April for the third Open Research Office session.

“Overall, I think this is helpful for researchers as well as IRB reviewers. We researchers can learn what it is the IRB is looking for and you, as the reviewer, can hear about our reservations and concerns firsthand. ”
Open Research Office evaluation

Sarah Reilly, MPH, Institutional Review Board (IRB) administrator in the Office of Research Compliance, presented “Helpful Tips on Completing the HRP-503 Study Protocol.” The topic proved to be popular as it attracted research teams from departments as widespread as neurology, nursing, social work, surgery and restorative dentistry, and institutions as diverse as the Microbiome Center, Institute for Healthcare Informatics, New York State Center of Excellence in Bioinformatics and Life Sciences, and the Buffalo Institute for Genomics and Data Analytics.

One of the most common causes of IRB rejection

The HRP-503 Study Protocol is an essential component of many submissions to the IRB. “It is the complete protocol for your study,” said Reilly. “It’s where you write your study plan, the rationale, the design, recruitment procedures. It’s the blueprint for what you’re going to do.”

She said an incomplete or incorrectly filled out HRP-503 is one of the most common reasons why a submission to the IRB gets kicked back to the researcher.

“If the study plan is accurately described, we can evaluate whether that plan meets criteria for approval,” she said. By holding the Open Office presentations, Reilly and colleagues hope to cut down on the number of clarification requests, and consequent delays in approval, by giving investigators a better sense of the purpose of HRP-503 questions and the kind of responses the IRB wants to see.

“But beyond protocol guidance, what we really want to do is to open a dialogue, a two-way conversation,” said Reilly.

Post-session evaluations show that this approach seems to be working. “Very beneficial session,” said one reviewer, “great for new research coordinators.”

Another respondent commented: “Overall, I think this is helpful for researchers as well as IRB reviewers. We researchers can learn what it is the IRB is looking for and you, as the reviewer, can hear about our reservations and concerns firsthand.”

Sessions held third Wednesday of every month

Open Research sessions are held the third Wednesday of each month and they rotate among UB’s four health science campuses. Coordinated by Clinical Research Facilitator Jami Radtke, MS, in the Clinical and Translational Science Institute, the meetings were instituted late last year to improve communication between research teams in the field and the regulatory administrators who oversee their work.

A brief presentation on a topic of interest to researchers is followed by an open-ended question-and-answer session, with the opportunity for informal, ad hoc, one-on-one consultations. The first Open Research Office session was offered in late January.

The format grew out of a Communications Working Group formed last year in response to a recommendation from an independent consultant. The consultant had been engaged by the Office of the Vice President for Research and Economic Development with the Clinical and Translational Science Institute to look for ways to improve UB’s clinical and behavioral research processes and communications.

The working group is headed up by Sanjay Sethi, MD, director of the Clinical Research Office, and Richard Karalus, PhD, director of the Office of Research Compliance. The group is one of two working groups formed in response to the consultant’s report which have been meeting on an ongoing basis since October 2017 to implement the recommendations.

Representatives from the following offices are working together to bring the Open Research Office sessions to the Buffalo Translational Consortium research community:

  • Institutional Review Board (IRB)
  • Office of Research Compliance (ORC)
  • Clinical Research Office (CRO)
  • Social and Behavioral Research Support Office (BRO)
  • Sponsored Projects Services (SPS) and
  • Clinical and Translational Science Institute (CTSI)