February 19, 2021
We are all pleased that the number of COVID cases is on a downward trend right now and the COVID vaccines are bringing new hope that we will be able to get more effective control of the pandemic. Clinical research visits continue to slowly increase and fortunately we have not received any reports of research participants contacting COVID through their research experience.
We strongly support the following recommendations:
1. Please continue to follow all COVID precautions as you go about your lives. We continue to find that JHM employees who develop COVID reported social contacts outside of work that appear to be the source of their infection. Nonetheless, observers within our community do observe situations where JHM employees are too close to each other, and not following appropriate protective measures, including correct use of masks and use of face shields. This is often around eating, where even a few minutes of close contact can lead to transmission.
2. While it is not easy to determine the etiology of minor symptoms like sore throat and fatigue, staff who become COVID positive frequently have come to work for a day or two before testing positive for COVID. We strongly recommend that you stay home whenever you are experiencing new symptoms, and develop plans for back up. We remain quite confident that if research staff socially distance as much as possible, wash their hands and wear masks and face shields when interacting with research participants the risk of transmission is very low. Hopefully these behaviors are becoming part of your work routine. We have done an outstanding job of protecting each other throughout the pandemic. Now is not the time to lose these healthy behaviors.
3. At the Homewood campus and in the School of Public Health, weekly COVID testing of faculty and staff with human interaction, including interaction with research participants, is now required. There are no School of Medicine or Health System requirements for weekly COVID testing for asymptomatic staff. If any research team thinks there is an increased risk of COVID transmission either because of intensity of interactions or the research participant characteristics, they can voluntarily decide to have asymptomatic research staff undergo periodic testing. These programs appear to need testing at least twice a week to reliably identify COVID outbreaks at a time when action might reduce risks.
DocuSign is available to support study teams seeking to implement an electronic consent option. The DocuSign team is currently working with 40 study teams to implement DocuSign for their research. Research teams interested in using DocuSign should submit an email request to firstname.lastname@example.org to initiate the process. Teams will complete a brief intake form to describe their electronic consent needs. Once it is determined that DocuSign is a good fit, teams will receive instructions and standard language to submit their request to use DocuSign to the IRB. After IRB approval is obtained, the study team will be trained to set up their consent in DocuSign and use DocuSign to facilitate the research consent process. For additional information about DocuSign please visit: https://ictr.johnshopkins.edu/programs_resources/programs-resources/i2c/econsent/
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation
Director, Institute for Clinical and Translational Research