COVID-19 Research Involving Humans

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 )

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 May 2020 - COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

13 May 2020,  - The FDA is issuing this guidance to assist sponsors in the clinical development of drugs for the treatment or prevention of COVID-19. Click to read FDA guidance.


FDA Guidance May 2020 - COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products

13 May 2020,  - FDA is issuing this guidance to provide general considerations to assist sponsors in preparing pre-investigational new drug application (pre- IND) meeting requests for COVID-19 related drugs1 for the duration of the COVID-19 public health emergency. Click to read Pre-IND guidance.


COVID-19 Human Research Coordinating Committee - Update 2 (IO)

12 May 2020 - To the UMB Research Community, The COVID-19 Human Research Coordinating Committee continues to meet weekly to collaborate on a comprehensive and coordinated research response to the COVID-19 pandemic.