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Clinical Research as Threat from COVID-19 Pandemic Decreases
June 7, 2021
The past year has seen many changes in the way human subject research is conducted both nationally and at Johns Hopkins. Our primary focus has remained the safety of participants and the study teams conducting the research. Protocols have reopened if the research teams wanted to move forward. Research participants and staff did not develop COVID-19 based on their participation in research. However enrollment in therapeutic clinical trials remains at about 75% of what it was when the COVID-19 pandemic changed our world.
As we continue plans to increase on-campus activity, I am writing to share updates regarding the restart process for human subject research at the Johns Hopkins School of Medicine.
Sunsetting of COVID Research Restart Committees:
Since June 2020, six designated Protocol Restart Committees have reviewed plans for safe restart of research to ensure study teams were ready to move forward to the IRB for approval of study restart plans. These include the School of Medicine’s Human Subjects Research Protocol Restart Committee (the HSRPRC), the Sidney Kimmel Comprehensive Cancer Center Committee, the Johns Hopkins All Children’s Hospital Committee, the Kennedy-Krieger Institute Committee, the School of Nursing Committee, and the Advanced Physics Laboratory (APL) Committee. We thank the members of these committees for their essential contributions to the safe restart of research with human participants. Ellen Mowry, MD, MS and Sumati Murli, PhD were particularly dedicated in chairing the SOM committee. Since the research restart process began, 1,721 research studies have been approved by the JHM IRB to restart their in-person research activities. In the same time period nearly 1000 new research applications have been approved or acknowledged by the JHM IRB.
Given the success of our research restart efforts to date, as of today, Monday, June 7, 2021, investigators are no longer required to secure approval from a research restart committee before proceeding to the IRB for approval of their restart plan. All requests to resume in-person interactions still must be reviewed and approved by the JHM IRB.
Investigators seeking to resume in-person interactions with participants, or start a new study involving in-person interaction must consider appropriate measures to safely conduct their research and incorporate those measures in the new applications or changes in research submitted to the IRB.
For more information on restarting your in-person research interactions, please review the IRB’s guidance here: https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/
DocuSign is available to support study teams seeking to implement an electronic consent option. The DocuSign team is currently working with over 150 study teams to implement DocuSign for their research, of which 26 are approved, trained and have their consent forms set up with nearly 100 consents now completed using DocuSign. Required training is available through myLearning and videos and documentation can be viewed on the DocuSign Confluence page: https://cscop.jhmi.edu/confluence/display/DOCUSIGN/DocuSign. Research teams interested in using DocuSign should complete the DocuSign questionnaire found on the ICTR eConsent page (see below) and email it to firstname.lastname@example.org to initiate the process. 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 may take training via myLearning to learn how 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/program-resources/i2c/econsent/
Consolidation of COVID ICTR Clinical Research Units:
With the declining number of COVID-19 cases, both inpatient and outpatient, we are closing the COVID-19 CRU at Greenspring Station on June 30th. Research teams using the Greenspring facility will transfer their studies to the Johns Hopkins Bayview campus with ICTR support. The JHBMC COVID-19 CRU will remain open in its current location, the employee south parking lot.
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation
Director, Institute for Clinical and Translational Research