Emergency Response to COVID: An IRB Story

In past "normal" times, when IRB members and leaders think about "emergency response," we imagine hospital emergency departments or public health mobilization efforts in the face of an epidemic or other health crisis—with the focus on helping others. COVID introduced a new perspective because the emergency we faced affected us personally and professionally, in addition to our researchers and our study participants. It forced changing so many facets of our work: halting in-person human subjects research activities to reduce risk, moving IRB operations to remote work, minimizing unnecessary submissions when studies shifted from in-person to remote work, providing guidance on how to safely collect data using remote mechanisms, and working with University leadership on how to safely re-start human subjects research. And it was all so sudden—or at least it seemed that way.

At the Johns Hopkins Bloomberg School of Public Health (JHSPH), we have an office of 10 people and two IRBs that meet weekly. We process about 500–600 new applications per year, including Exempt, Non-Exempt, and "not human subjects research" submissions. Our portfolio includes research all over the world. In late February, 2020, our Vice Dean for Research, who oversees the IRB Office and all research activities at the School, was involved in discussions with JHU leadership anticipating that the University would need to move to remote work. He asked me to come up with a plan for the IRB Office. I worked with my staff of 9 and on Monday, March 2, I sent him an email outlining what we came up with:

1. 1. Communications: Change our telephone voice messages to tell folks to communicate via email. Inform the IRB Chairs and Members about our plan and help them access Zoom if needed.

2. 2. Computers: Make sure all staff have computer access at home—and let them take office computers if needed.

3. 3. Internet access/firewall: Have staff test access to office databases and systems from home and obtain IT assistance if necessary.

4. 4. Office files: Create electronic files for any hard copy files that we maintain in the office.

5. 5. Zoom: Set up Zoom accounts to permit our weekly IRB meetings to proceed electronically. Learn about Zoom—who needs to have accounts, how to host meetings, send new meeting invites for all standard meetings with Zoom link.

   And finally,

6. 6. Set up a test day for staff to work from home to make sure everything worked.

We chose Monday, March 16, as our test day and spent the rest of the week having staff check out and resolve internet access issues from home, scheduling Zoom meetings with each other, and trying to work out the kinks in our plan. By the time we had thought through all the logistics of transporting computers back and forth, we decided that it would be better to have us schedule a test week instead of a single day. So the plan was to work from home the week of March 16.

But then, life and COVID intervened. The virus was spreading and a shutdown loomed. By Wednesday, March 11, the School and University began communicating the possibility of having everyone go home and initiate remote work. Thank goodness we had a plan and everyone knew what to do.

My personal story has a little twist. We have a son and daughter-in-law living in Wellington, New Zealand. They were expecting their first child in late March, with no other family nearby. We planned to visit in April. On Wednesday, March 11, they called us and said that the New Zealand government was calling all Kiwis home in anticipation of a border closing. The message was, "Come now or you won't be able to come later." We scrambled and moved our tickets up to Saturday, March 14. I informed the Vice Dean of my situation, and I remember him saying, "If you go, what happens if you can't come back?" I sort of shrugged my shoulders and said, "We'll see what happens."

Our granddaughter was born on March 14 (NZ time), while my husband and I...