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.
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
Updated July, 2nd, 2020 of original March 2020 Guidance. Read full guidance here.
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.
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.
6 April 2020, the State of Maryland and UMB Financial Services – Disbursements continue to process payment requests in accordance with established regular payment processing requirements. The temporary modifications described below are effective until the UMB COVID-19 Telework Policy is lifted. Click to read announcement.
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19
March 18, 2020 To access news release click here
HRP-360 - WORKSHEET - COVID-19 Human Subject Research Preliminary Review
620 W. Lexington St.
Second Floor
Baltimore, MD 21201
Office hours are 8:30 a.m.-4:30 p.m., Monday through Friday.
* The Human Research Protections Office is working remotely and is ready to assist our community during the COVID-19 pandemic. During this time, we request you contact us via email to promote a prompt response. With apologies, currently voicemail messages may be delayed in reaching us and cause a longer wait time for us to respond to your requests. We thank you for your patience and look forward to assisting you.
The University of Maryland, Baltimore is the founding campus of the University System of Maryland.
620 W. Lexington St., Baltimore, MD
21201 | 410-706-3100
