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Many IRBs have seen clinical trial submissions decline since the COVID-19 pandemic began. Clinical trials also were put on hold. But work at Great Bay Community College — a one-person IRB office — has increased.
“It does, to a degree, feel like I’m doing twice the amount of work,” says Aimee E. Huard, PhD, professor and chair of social sciences and IRB chair at the college in Portsmouth, NH. “We’ve had more applications during the pandemic. We’re almost exclusively an SBER [social-behavioral-educational research] IRB.”
Huard believes the influx of new submissions is because the pandemic closed in-person classes and activities, giving instructors more time for starting minimal-risk studies.
“The pandemic gives professors and instructors a chance to think about their scholarship, and to study and focus on their own interests. They’re doing research,” she says.
Most of the studies continued after the pandemic, but some were stopped. For instance, all studies that involved K-12 schools were paused, Huard says.
“Almost all of the studies were in the early stages, and we didn’t have anything actively impacted by COVID-19,” Huard says. “Some studies have had to assess how interviews and in-person data collection were impacted remotely.”
Huard has not received additional funding during the pandemic. She has continued to operate the IRB as efficiently as possible, despite these challenges:
• Educating researchers. “Education is the biggest challenge we have,” Huard says. “Many of my colleagues have had minimal interactions with an IRB. If they did work with an IRB, it was during their graduate research.”
The IRB does not have a budget to cover educational resources, such as CITI human research protection training. Huard assembles free resources in a grassroots educational program. Researchers are tested on the regulations and information she provides.
“The education programs are what I can find or borrow from things like PRIM&R resources, the SBER Network, and standards from the National Institutes of Health,” Huard says. “Typically, I use these resources as a place to talk about the things they did or did not know that surprised them,” she adds.
After researchers pass a quiz, she sends them an email as certification of their passing educational requirements.
• Slow response times. Every IRB copes with slower-than-desired turnaround and response times. The Great Bay Community College IRB is no exception.
“As a one-woman show, the response times tend to be slower than I would like them to be,” Huard says.
Each day, Huard receives more emails than she can handle. She sends quick replies saying she will get back to them in a few weeks or longer. “I’m starting to answer some of the emails, where I said I’d get back to them in May, and now it’s May,” Huard says.
“I’d like to help faculty across the system with their students and personal research projects and projects in conjunction with different institutions, such as local hospitals or four-year university systems,” she adds. “The response time is slow when I have department duties and things like that.”
Huard uses a few methods for improving the response time. One is an auto-response on emails. She also asks the IRB to update its response times once a month, based on her workload.
“I use our board members as advocates, and they help me triage the work when things appear in my inbox,” she says. “Each board member represents one of the campuses that is part of the system.”
• Budget. A small IRB’s limited budget is a challenge when it comes to providing training, improving turnaround times, and handling all the varied study submissions.
“I cannot provide our voluntary board with baked goods and coffee, and I would love to be able to reward them for all of their hard work,” Huard says. “I have thought about getting free coffee for them when the economy is better.”
The revised Common Rule’s changes to continuing review have helped, but there still are activities that IRBs need to do. That workload remains, Huard notes.
For example, the Great Bay Community College IRB sends surveys to researchers that previously would have been up for a continuing review.
“We make sure we have the most up-to-date information on their projects,” she says.
The IRB uses its college’s technology for remote meetings. Also, the IRB accepts electronic PDF document submissions, but does not employ a fully electronic submission process, she says.
• New rules, practices, and regulations. Another challenge, particularly for SBER research, involves projects that direct students and/or faculty to fill out surveys and conduct interviews.
“We can’t do the interview piece because our state is still on shutdown, for the most part,” Huard says. “Researchers can’t do anything with an [in-person] interview until we have more guidance from various governmental entities.”
The challenge is to ensure the survey studies and other research submitted by faculty meet both existing regulations and new rules during the COVID-19 crisis.
“I have some researchers who are working remotely from different regions because their programs are online-based,” Huard says. “If they live in Massachusetts, but are doing research in New Hampshire, it’s a reasonable drive — but it’s in two different states with different regulations.”
In the early days of the pandemic, one researcher started to ask for IRB input on a study that met all human research protection regulations. But, as the researcher and Huard were communicating, state and federal regulations changed for the pandemic, she recalls.
“Things have settled down a little in that way, but there was a two-week period when everyone was trying to figure out what was happening,” Huard says. “I had a flurry of emails in my inbox.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, reports she is on the speakers bureau for AORN and Ethicon USA and is a consultant for Mobile Instrument Service and Repair.