Narrative Inquiry in Bioethics

The week of March 9, 2020 started off like any other week in an IRB/HRPP office. Two new staff had started in our office within the past two weeks, and we were training them. There was talk of coronavirus and COVID-19 in the news as it had made its way to the US, but our health system was not yet feeling a major impact. Then, as each day passed, there were new developments. Rumors started flying that someone in the building in which the HRPP office is housed had come down with COVID-19. Staff started panicking. Leadership at work and within research reassured everyone that if we all follow the basic guidelines, we will stay safe. Those guidelines were wash your hands, cover your mouth when you sneeze and cough, and stay home if you feel sick.

By Thursday morning, March 12, 2020, it was clear that staff did not feel safe coming in to work any longer. The challenge that day was setting everyone up (including two new employees who had been with us for less than three weeks) to work remotely, as our work force was generally not remote. My assistant director and I worked with IT support to make sure everyone had a functional computer to use at home, with which they would be able to login to our network. By the end of the day Thursday, all the HRPP staff had been told they could work remotely until told otherwise.

Once the staff were settled, I was able to focus on work in the office and decisions that had to be made:

• • Do we need to put out a notice closing down research? Or can we allow investigators to make their own choices regarding their studies and continued activity as long as it was in compliance with the health system policies being put forth to combat COVID?

• • Will research studies be opening up? What IRB will be reviewing them? Our health system's IRB or an external IRB?

• • For studies coming through the IRB, what type of turnaround are investigators expecting?

It became clear that research leadership had to put out a memo providing direction on how ongoing research studies should be handled. Investigators were confused and not sure whether they could move forward or not. They needed direction. Thus, over the course of a weekend, the HRPP worked together with clinical research operations.

Together, we sent out a notification requiring enrollment on open studies be halted. In addition, we asked for research activities to be paused, unless the studies were of potential benefit and pausing activity could cause harm to an enrolled subject.

The next agenda item was determining which COVID-19 research studies we should open within our health system. A small group was formed to vet all the COVID-19 trials that were coming our way and determine whether they were feasible to move forward. The decision makers felt very strongly that we should try to limit our trials to randomized controlled trials, in an effort to put the best science forward. The first trials we opened were industry sponsored multi center studies, for which we relied [End Page 76] on an external IRB. It was amazing how fast we were able to get these studies opened when all efforts across the organization were focused just on this. We opened up three trials within about a week of being approached about the studies. The health system's HRPP office worked side by side with the study team to assure all regulatory and institutional requirements were being met, as the study team was applying to the external IRB.

The industry trials opened and enrolled very quickly. The next focus was on an investigator initiated study that would be opened within our health system only. We are a 23 hospital system. Thus, even when we are a single site we have the opportunity to enroll participants at 23 hospitals. This investigator initiated study was the first COVID-19 treatment trial coming through our IRB. Fortunately, our IRB moved to a flexible roster video conference system in 2014. Therefore, the change to a...