Letters to the UMB Community

UMB Phased Research Plan: Stage 1 of Clinical and Community-Based Human Subjects Research

July 14, 2020

Dear UMB Community,
 
Today, I am announcing the University of Maryland, Baltimore (UMB) will enter Stage 1 of clinical and community-based human subjects research Monday, July 20, 2020. The Guidelines for Resuming Human Subjects Research can be found here.  
 
UMB announced the restart of this research June 25, 2020, at Stage 0, which involved planning and preparation for the gradual and deliberate restart of clinical and community-based research.
 
  • During the Stage 1 phase, we will continue minimal-risk studies that are remote or no contact.  
  • Research (including community-based research) that has the potential for direct benefit to the research subject and requires in-person visits at UMB-related facilities may be resumed upon approval of the UMB Environmental Health and Safety Checklist for Resuming Clinical Research and the Operations Assessment Tool by UMB’s Institutional Review Board (IRB). Documentation must be submitted through the Reportable New Information pathway in CICERO. The forms can be found on the Human Research Protections Office website.  
  • If Stage 1 goes as planned, we will begin the expanded research phase, labeled Stage 2, two weeks later Aug. 3, 2020. Stage 2 continues to allow minimal-risk studies and studies with the potential for direct benefits to the research subject that require in-person visits at UMB-related facilities. Stage 2 also allows for the resumption of studies that do not have the potential for direct benefit to the research subjects requiring in-person visits at UMB-related facilities. This includes interventional studies with no therapeutic intent, screening/diagnostic, and observational studies.  
 
As with everything we do, your safety and well-being are foremost in our minds.
 
If you have questions or need more information, please contact Laurie Locascio, PhD, vice president for research. For questions on human subjects research, please contact Julie Doherty, DM, MSN, director, Human Research Protections Program; or Robert Rosenthal, MD, chair, IRB.
 
Sincerely,
 
Bruce E. Jarrell, MD, FACS
Interim President

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