Small but Nimble: Riggs Institutional Review Board Responds to the COVID-19 Pandemic
Kim Hunter-Schaedle, PhD, IRB Administrator & Research Administrator
Dr. Hunter-Schaedle has been accepted to present a poster about this topic at the Public Responsibility in Medicine and Research (PRIMR) 2020 Advancing Ethical Research Conference, which will take place virtually in December 2020. Her poster is titled: “The View from a Tiny House: Adapting Our Small IRB Operation in Response to the COVID-19 Pandemic.”
The COVID-19 pandemic brought change to the way many of us do our work at the Austen Riggs Center. This has included our Institutional Review Board (IRB) operation. The IRB is a committee comprised of representatives from Riggs and our regional community, and it oversees research done on site at Riggs, or conducted elsewhere by Riggs staff, when that research involves recruiting human subjects or studying human subjects data. A number of Riggs clinical staff pursue research questions that arise from their clinical work; and, as IRB and Research Administrator, I am often an early point of contact for these ideas, as most will require IRB approval. As the sole dedicated IRB office staffer, I manage a small portfolio–in 2019, we had 22 active research protocols. This is boutique-sized in contrast to the IRB offices at large academic institutions that may handle many thousands of protocols and have a large IRB staff. But I can provide personal service to our investigators and help them troubleshoot the questions the IRB might ask.
Our small size has been advantageous during the COVID-19 pandemic. When a federal state of emergency was declared in the United States on March 13, we were already aware from news shared throughout the national IRB community that in-person interactions with research subjects would certainly be impacted by COVID-19. On March 16, we issued our first COVID-19 guidance for Riggs researchers, recommending elimination of in-person research interactions, and the use of video meetings instead. In a rapidly-evolving situation, on March 18, just two days later, in-person research subject interactions were fully suspended at Riggs, and they remain so until further notice. This guidance recognizes institutional, state, and federal COVID-19 guidance, and are consistent with actions taken at other research institutions.
From mid-March on, many institutions’ IRB operations shut down entirely (except for review of life-saving research protocols, or COVID-19 treatment/vaccine-related studies). At Riggs, as the Center has continued to provide care for our patients, our IRB has continued operation without interruption–though some changes have been necessary. On April 21, Riggs IRB released guidance for the principal investigators of IRB protocols. This provided an extension through June 30 for all research personnel to submit mandatory items due before then, including renewal of protocols, research training, and collaborator agreements. This included our external collaborators who are an important part of Riggs research. In 2019, Riggs IRB protocols included agreements with 33 external collaborators at 15 institutions in the United States and Mexico. We anticipated that, with many people working from home, with new schedules and priorities, the flexibility in this guidance might provide a welcome buffer.
Excitingly, in the midst of the pandemic shutdown, Riggs IRB approved a COVID-19 study. Headed by Research Psychologist Dr. Katie Lewis, it examines the impact of loneliness and social distancing on mental health during the pandemic, enrolling subjects and collecting longitudinal data through a smartphone app. Given its time-sensitive focus on experiences under the shutdown, Dr. Lewis was keen to initiate the study as soon as possible. At the same time, the IRB must complete a careful and thorough evaluation of each study with an emphasis on the risks and benefits balance for human subjects. The technology used was familiar to the IRB from another of Dr. Lewis’ protocols discussed below, which helped; nevertheless, review included a security assessment by the Riggs IT director and consultation with Riggs clinical leadership before it received Expedited Approval from our IRB Chair on April 8. From Dr. Lewis’ first outreach to the IRB, to the date of IRB approval, took just seven business days–a speedy timeline for any IRB protocol. This study has proved successful and Dr. Lewis has far exceeded her recruitment goal.
Dr. Lewis has also updated another of her ongoing IRB protocol to “fully remote.” This study, which recruits Riggs patients and collects data through a phone app, had also included in-person meetings with the subjects, and therefore had been suspended since mid-March. With Dr. Lewis’ modifications to go all-remote, the study is approved to re-start. The review and approval took place at the June 3, 2020 meeting of the Riggs IRB–a Zoom meeting, of course.
During the COVID-19 pandemic, our IRB office has been able to respond so rapidly–modifying our IRB operations, approving Dr. Lewis’ protocol–because in the past year, we completed a full refresh of Riggs IRB operational procedures and forms. This was in response to recent changes effected in the Common Rule, the federal regulations that guide the operation of IRBs across the United States. And in early 2020, we created an IRB site on The Hub–the Riggs intranet for our staff–to share everything needed to prepare and submit an IRB protocol. This was especially useful for staff working remotely during the pandemic.
Like everyone else, I look forward to some normality returning to our lives–whatever that looks like. But in the meantime, I am glad to support the continuing pursuit of research.
Read more about our current research at Riggs: www.austenriggs.org/research-riggs and our IRB: www.austenriggs.org/research-riggs/institutional-review-board