COVID-19 Research Involving Humans

Reminder - Human Subjects Research Remains in Stage 2 of Resumption Plan
December 17th, 2020 - The decision to move to Stage 2 of the Human Subjects Research Resumption Plan was announced August 25th, 2020 and remains in place.

Resumption Plan - Guidelines | Resumption Plan - Process | Resumption Plan - Checklist | Resumption Plan - Assessment Questions

 

Aug. 25, 2020

Dear Colleagues:

University of Maryland, Baltimore (UMB) Interim President Bruce E. Jarrell approved, effective immediately, the initiation of Stage 2 for Clinical and Community-based Human Subjects Research.

The following activities (both Stage 1 and Stage 2) are now permitted to resume with the appropriate preparation and approvals as described in the Guidelines for Resuming Human Subjects Research found here:

Stage 1 activities permitted with approval:

  • Minimal-risk studies that are remote or no contact.
  • Research with potential for direct benefit to the research subjects that  requires in-person visits to UMB-related facilities.

Stage 2 activities permitted with approval:

  • Research with no potential for direct benefit to the research subjects that  requires in-person visits to UMB-related facilities.

A decision to move to Stage 2 was based primarily on the safe and successful implementation of research activities in Stage 1.  At all stages, we will continue to monitor our ability to protect the health and safety of everyone involved.

If you have questions or need more information, please contact Julie Doherty, DM, MSN, director, Human Research Protections Program, or Robert Rosenthal, MD, chair, Institutional Review Board.

Additionally, the following contacts are provided to assist with other issues that may arise as researchers plan to restart activities:

  • Space modifications for health/safety purposes: Melissa Morland, Operations Maintenance;
  • Parking issues: Robert Milner and Angela Hall, Parking and Transportation Services;
  • Cleaning/custodial services: Denise Meyer, Environmental Services;
  • Space standards for physical distancing: Luke Mowbray, Real Estate, Planning, and Space Management.

Sincerely,

Laurie E. Locascio, PhD

Vice President for Research, University of Maryland

Chair, UMB Research Advisory Task Force

 

Margaret M. McCarthy, PhD

Professor and Chair, Department of Pharmacology, University of Maryland School of Medicine 

Deputy Chair, UMB Research Advisory Task Force

 

Susan Buskirk, DM, MS

Vice President, Chief Accountability Officer and Institutional Official

The University of Maryland, Baltimore (UMB) has initiated a comprehensive and coordinated response to the influx of human research protocols being developed and initiated that include human subjects related to the COVID-19 pandemic. UMB desires to facilitate the efficient, effective, and safe submission, review, and conduct of human research. Key stakeholders across disciplines, departments, and Schools, along with representatives from University of Maryland Medical System are working to prioritize and support this important research. This site provides information on UMB’s Committees and Task Forces convened in response to the COVID-19 pandemic and human subjects research arising in response, the Biospecimen Repository being created under an umbrella protocol, COVID-19 Clinical and other Trials, and provides a FAQ for the research community.

*This page will be updated regularly as new developments occur and additional information becomes available.


 

To provide a comprehensive and coordinated response to the need for human subjects research during the COVID-19 pandemic, UMB has formed a number of specific Committees and Task Forces. The Committees and Task Forces have brought together multidisciplinary stakeholders to create policies and processes supporting our research efforts. This page provides information on each, including membership and actions taken to date.


 

UMB is conducting Clinical Trials testing potential therapies and interventions for COVID-19 in partnership with University of Maryland Medical Center and other University of Maryland Medical Systems facilities.

This page provides information on those Clinical Trials, as well as links to federal resources for finding Clinical Trials.


 

UMB is conducting other Trials, including but not limited to surveys, chart reviews, and epidemiological studies to understanding COVID-19, associated risks, and effects.

This page provides information on those Other Trials being conducted.


 

An umbrella protocol for the collection, storage, and distribution of biospecimens for COVID-19 research is being implemented. This will allow for a streamlined process, reducing barriers for researchers to obtain the specimens necessary for scientific research. This page provides important information on how to request biospecimens from the Repository. 


 

UMB has put together a FAQ of common questions to assist researchers and others interested parties during the COVID-19 pandemic.


 

Here you will find a link to the University of Maryland, Baltimore’s Investigator Toolkit, which provides federal and other resources for identifying and applying for funding. Additional information for identifying sponsors and grants is available through the Office of Research and Development.

Communications

(Click to read All Communications )

UMMS Town Hall - Understanding the COVID-19 Vaccine

January 2021, University of Maryland Medical System Holding COVID-19 Webinar on January 18th, 11-12 pm: Finding Hope on Dr. Martin Luther King Jr. Day – A Town Hall on Understanding the COVID-19 Vaccine

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

21 September 2020: The UMB COVID-19 Risk Statement 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.

Recorded Q&A Session from July 17th, 2020
UMB Guidelines for Resuming Human Subjects Research

Q&A Session with Dr. Robert Rosenthal, Chair of UMB’s Institutional Review Board, and Dr. Julie Doherty, Director of the Human Research Protection Program. 

The session focused on providing information and answering questions related to UMB's Guidelines on Resuming Human Subject Research, including preparing for progression to Stage 1.  

Watch Here

Resuming Human Subjects Research, June 23, 2020 - Guidelines, Process, Checklists

The UMB COVID 19 Research Advisory Task Force was charged with developing guidance for restarting research considering the ongoing pandemic. This guidance provides a tiered, staged approach for resuming human subjects research activities, responding to the varied need for personal contact, physical space, and the ability to maintain personal and environmental safety precautions.

Resumption Plan - Guidelines   |  Resumption Plan - Process  |  Resumption Plan - Checklist  |  Resumption Plan - Assessment Questions


 

FDA Guidance on Conduct of Clinical Trials during COVID-19: For Industry, Investigators, and IRBs

Updated July, 2nd, 2020 of original March 2020 Guidance. Read full guidance here.