All Communications

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.


 

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.

Webinar: UMB Human Subjects Research - Q&A Session

April 14th, 2020, 11:00am - Session focused on providing guidance and information, as well answering questions, regarding human subjects research under UMB’s COVID-19 pandemic guidelines. Open Full Article to view Recording of session.

Proposed or Planned COVID-19 Human Subjects Research Protocols

10 April 2020, COVID-19 human subjects research protocols proposed or planned will be subject to a preliminary review to allow for prioritization and efficient processing. Click Title for full article and the required Worksheet

COVID-19 Prioritization Communication from the Institutional Official (IO)

April 9th, 2020 - All Researchers, IO providing our research community with continuing information about the new and ongoing activities UMB is taking to facilitate human subjects research during the COVID-19 pandemic.

Temporary Modifications to the Research Study Participant Payments Procedure

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.


COVID -19 Human Subjects Research

April 1st, 2020 - Institutional Official provides our research community with information about some of the activities the University of Maryland, Baltimore (UMB) is taking to facilitate human subjects research during the novel coronavirus (COVID-19) pandemic.

FDA COVID-19 NEWS RELEASE - Updated March 27, 2020

 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19


FDA NEWS RELEASE - Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials

March 18, 2020  To access news release click here


Announcement - UMB IRB and HRPO Research Guidance Regarding COVID19

Mar 12th, 2020 - All Researchers, Please read the guidance on responsible conduct of active human subjects research regarding COVID-19.