By Melinda Young

Human research protection programs (HRPPs) and IRBs nationwide responded quickly and efficiently to changing processes and policies during the early months of the COVID-19 pandemic, according to the results of a recent study.1

Investigators surveyed HRPP staff, IRB members, and researchers across the United States. “We used census divisions and sent out a call for participants from two institutions in each region of the census tract,” explains Nicole Lederer, MEd, associate compliance analyst for the University of Toledo HRPP. “We tried to get a sample from all through the U.S. We were hoping to gain insight on where improvements could have been made to make things flow a little more smoothly.”

Many universities and research institutions moved to remote work schedules in March 2020. Investigators wanted to see how this affected their work, says Mahesh Pillai, MD, PhD, CIP, associate compliance analyst at the University of Toledo.

Sixty percent of participating IRBs and HRPP staff said their institution’s administration provided clear directives regarding procedures for conducting research with human subjects during the COVID-19 crisis. Another 26% reported they received some directives, and 14% reported none.

“These results posed additional questions,” Lederer says. “A lot did pose clear guidance, but some did not. Where was the breakdown?”

Another survey question asked how well the IRB accommodated changes implemented by their institution. Ninety-three percent of respondents said their IRB was accommodating, and 7% were neutral. The neutral response might have been from institutions that shut down research during the crisis, Lederer says.

The study also revealed 72% of participants believed their COVID-19-related research was reviewed and approved faster than usual, and 16% said it was the same. “Everyone was trying to figure out what was going on and how to help the situation,” Pillai says.

“It was a public health crisis, and everyone was concerned about this,” Lederer adds. “COVID research was coming in, and it was very important to make it a priority, to really move it along quickly.” Researchers wanted to obtain data on what was happening related to the pandemic during this huge public health crisis, she notes.

About 39% of the survey respondents said they planned to add a section on disaster preparedness to their HRPP procedures. Research institutions might have created disaster plans for localized crises, such as major weather events or data breaches, but many had not anticipated a disaster that would shut down the entire nation, as well as many international supply chains.

“We haven’t had a major pandemic in a while; the last one was in 1918,” Pillai says. “We haven’t had a pandemic of this magnitude that would shut down everything, and I don’t think we saw it coming.”

Turning to Agencies for Guidance

IRBs and HRPPs that were looking for guidance referred to federal websites, such as the U.S. Department of Health and Human Services (HHS), for information on creating policies and procedures during this new pandemic, Pillai explains. For example, HHS offers emergency preparedness information on COVID-19 and HIPAA.2 The Food and Drug Administration and the Office for Human Research Protections (OHRP) also offer guidance on COVID-19, including crisis management information.3

“OHRP’s guidance document on disaster preparedness was not designed for a national pandemic; it was localized,” Lederer explains. “Planning for a national pandemic was not on the forefront of any HRPP offices’ minds, and it wasn’t made a priority.”

The fast and efficient move to remote IRB work by most HRPPs likely was facilitated by the fact that most larger research institutions had implemented electronic IRB submission systems. “Since they have flexibility, they could do more of their work remotely,” Pillai says.

It also helped that federal agencies issued guidance documents fairly quickly, and the national shutdown of in-person activities gave IRB administrators more time to create revised or new policies and procedures for the pandemic. “Institutions and higher administration were quickly able to formulate their own internet procedures, and those procedures were implemented really fast,” he says.

Administrative tasks that were not a priority were put on hold. “Those tasks are all very important,” Lederer explains. “But when it comes to accommodating changes associated with a pandemic, those are the kinds of things that probably were put on hold so the public health crisis could be addressed and research participants were protected.”

Sociobehavioral and educational researchers adapted more easily to the new virtual reality of IRB and research work because they already conducted many online and virtual research activities. “For them to modify their procedures was not something that was uncommon to most of these researchers,” Lederer notes. “Making that virtual transition was something they were already familiar with in terms of informed consent and confidentiality measures.”

Although the biomedical research community was less familiar with virtual processes, they adapted. “Biomedical research institutions had to determine whether research was essential or provided direct benefits to participants, and they had to figure out which of these procedures can be conducted on the phone or Zoom call,” Pillai explains. “Then, they made changes to their research to accommodate these new procedures.”

As the pandemic continues — and some areas likely will see their COVID-19 cases and hospitalizations drop faster than other areas — research sites will need to adjust their policies and activities to what is happening in their individual states, Lederer says.

“We had the majority of respondents indicate they followed guidelines as implemented in their state to create guidance to protect human subjects during the pandemic,” she says. “Institutions are following what their states are doing. If their state is shutting down, they’re shutting down.”

States and research institutions will need to keep a close eye on the COVID-19 numbers to inform future decisions, Pillai says.

“I think there will be regular evaluation of the procedures,” he adds.

REFERENCES

  1. Pillai MR, Lederer N. Impact of the COVID-19 pandemic on human subjects research. Presented at the PRIM&R Advancing Ethical Research Virtual Conference, Dec. 1-2, 8-9, and 15-16, 2020. Poster/Abstract:46.
  2. U.S. Department of Health and Human Services. Emergency situations: Preparedness, planning, and response. Content last reviewed Jan. 20, 2021. https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/index.html
  3. Office for Human Research Protections. OHRP guidance on coronavirus: Research guidance on coronavirus. Content last reviewed April 8, 2020. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html