Clinical Research During the COVID-19 Pandemic

When the news about COVID-19 spreading in various parts of the world and then in New York City was reported the first week of March, it still seemed very distant. It was work as usual, but we started noticing institutions all over the country discussing ramp down plans as stay at home orders were being issued in various parts of the country.

The week of March 9^th, the University started discussing ramping down plans for research. Laboratory-based researches were well versed with emergency preparedness procedures. After the devasting losses suffered during hurricane Allison in June 2001, laboratory researchers had developed a robust plan for preparedness, which they put to use several times since during hurricane season each year. However, there was not a similar plan for clinical research. Developing a ramp down plan for clinical research proved very challenging. Every research study is different—a plan for an oncology clinical trial with an investigational agent needed to be different from a research study on learning methods for elementary school kids. It was helpful for us to focus on the main considerations, which was to ensure the safety of participants enrolled in clinical research studies, minimize exposure of patients, participants and research staff and to be mindful of availability of resources such as PPE and other clinic and hospital resources. On March 19^th, when Harris County and several other surrounding counties started instituting stay at home orders, we were ready with a plan. In addition to asking researchers not to enroll any new participants in clinical research that would involve in-person visits, the plan asked researchers to make case by case decisions based on these same principles for any participants who were already enrolled in clinical research studies.

IRB Operations

Our IRB has been using a fully electronic IRB system since 2004, so we were sure we could keep the IRB operations going during the remote working period. However, conducting IRB meetings virtually was not something we were familiar with. We were very proud of our high tech conference room with laptops, large screens and teleconferencing capabilities. Our only experience having remote participation was when we had a consultant or an alternate call in by telephone, or occasionally video conferencing. Our IRB members enjoyed the in-person camaraderie and we joked that each of our 4 IRB Panels had a character. We were not ready to meet virtually—so for the first week, we had 8 people in the large conference room, socially distanced, with the rest of the members on WebEx. It was a disaster. Most of the time in the meeting was spent reminding members in the room to speak up because those on WebEx couldn't hear them. It was not difficult to decide that our only option was to go a hundred percent virtual. It took a few meetings for us to learn how to conduct the meetings effectively and also practical matters such as recording votes of each member. Soon, IRB meetings were running smoothly with many members saying that they prefer this format and would like to continue to meet virtually even after the pandemic restrictions have eased. Most IRB meetings had record attendance and it was much easier to schedule investigators to join in to answer member questions. What had appeared to be an insurmountable challenge turned out to be an advantage.

In the first few weeks in this new era, we saw a slowing down of new submissions, mostly because no new enrollment was allowed in clinical research studies. Researchers must have felt there was no point in initiating new trials. However, this was just the calm before the storm. Within no time, there was a surge in research related to COVID-19. The number of new applications that our IRB received in 2020 was 25% higher than 2019. COVID-19 related research accounted for more than 20% of new applications to the IRB. Many of these COVID-19 proposals were urgent and the IRB office would receive calls and emails from Principal Investigators and research staff asking for an expeditious review.

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