March 15, 2020
As the COVID-19 epidemic has progressed, I understand clinical research teams are making many decisions about which research activities need to be placed “on pause” or modified. Promoting social distancing is our goal. As we make these decisions, I trust all of you will continue to make the safety of our research participants the top priority. There are now new institutional policies that also need to be reviewed as you make these decisions.
As I described in earlier emails, you need to make it your daily practice to check the JHM IRB website to guide your activities. There is new guidance on how to make decisions about stopping and continuing research (Essential Information for Human Subjects Research Teams Related to COVID-19), use of a Research Participant COVID Information Sheet, and policy to stop onsite external monitoring visits. We have an FAQ section that is changing on a daily basis. There are also tips on how to better conduct research phone visits and zoom visits on the ICTR website.
At this point in time the IRB is not overwhelmed with requests for help or reviewing CIRs. We will let you know if the IRB is not able to respond and the review process needs to be modified.
Our Johns Hopkins Medicine research community is responding well to the COVID epidemic. We have several COVID related protocols open or about to open because we understand that research is essential for helping us learn how to respond to epidemics like the COVID-19 situation. We are not aware of any research participant complaints related to the information they have received or their safety concerns. I applaud the research teams for how they are supporting research participants who may be anxious or having difficulty responding to the uncertainty. Continue to support each other as research team members may worry about their own health as well. If work settings are crowded and you have to be onsite, consider instituting staggered work schedules. Thank you for the flexibility you have already demonstrated and will be needed in the days ahead. Many individuals in our research community have already stepped up when asked to help out. Please let me know if you have suggestions for how we can better respond to this epidemic.
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation