Announcement: UMB Research Community - COVID-19 Risk Statement for Human Research Participants

University of Maryland Baltimore Research Community,  

Hope that everyone is safe and well during these extraordinary times.

The UMB COVID-19 Risk Statement issued by the UMB Human Research Protections Office and the UMB IRB (HRPO/IRB). The document and process outlined is a collaborative effort between UMB HRPO/IRB and UMB Legal Counsel.   

The UMB COVID-19 Risk Statement   (UMB COVID-19 Risk Statement - Spanish) provides the research community with the standardized COVID-19 risk language to share with research participants, or their Legally Authorized Representative (LAR) who are scheduled to visit the UMB campus and/or its affiliated off-campus sites.  

Facts to know:  

  • The UMB COVID-19 Risk Statement must be shared with any participant or legally authorized representative (LAR) who is scheduled to visit the UMB campus and/or its affiliated off-campus sites. (New or currently enrolled participants/LARs). 
  • This is a standalone document and should not be combined with an informed consent document. 
  • The use of this document is required for any study, approved by the UMB IRB or an external IRB. 
  • The COVID-19 Risk Statement may be verbally administered or in a written form.  Documentation that the information was shared must be maintained within the research files. 
    When sharing in a written form, researchers may opt to obtain the signature of the participant/LAR when they arrive at an approved location for research visits. 
    When verbally administered, or when a signature is not obtained, the researchers must document their conversation with the participant/LAR in their research files.  
  • IRB-approved studies must begin using the UMB COVID-19 Risk Statement immediately.  A modification to current studies solely to utilize the UMB COVID-19 Risk Statement is not needed. However, the next time a modification is submitted, the UMB COVID-19 Risk Statement must be included at that time.  Check with the external IRB on their specific  
    requirements for timing of submission of this document.  
  • New study applications  (both internal and external IRB ) must include this document as part of their CICERO submissions.  

Please address any questions to Julie Doherty @ jdoherty@umaryland.edu. Thank you.

 

Dr. Julie Doher​ty, DM, MSN, RN, CIP, CCEP

Executive Director, Human Research Protections Program

Office of Accountability & Compliance

University of Maryland Baltimore


Back to Human Research Protections