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

Human Research Protections (HRP) is a comprehensive program that affords protections for all human research participants and is under the direct leadership of the Vice President and Chief Accountability Officer. This website is designed to provide users with the most up-to-date information related to conducting research with human participants.

Full Accreditation by AAHRP

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Institutional Official (IO), Dr. Susan Buskirk

The IO is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. 

UMB HRP Components

The main focus here is to provide information, resources, and instructions for completing the review process through the IRB. While the IRB is a key player in the HRP program, there are many other components within UMB critically involved in protecting human participants. Click here to learn more.

What Can Be Found Here

For Researchers: This resource helps investigators design, write, and organize research protocols; maintain compliance with policies and regulations; create and submit IRB applications via CICERO.

 

HRP Office: Information regarding its role in coordinating the Human Research Protections Program and providing support for the UMB Institutional Review Board (IRB). Contact information and informatics regarding submission processing times.

 

Institutional Review Board (IRB): Information about the board and the executive members and their role in approving, monitoring, and reviewing biomedical and behavioral research involving humans.

 

For Research Participants: This section assists former, current, or prospective human research participants in obtaining information or offering input regarding research and clinical trials.

Announcements

(Click to read all Past Announcements)


 

FDA Guidance Oct 2020 - Combating COVID-19 with Therapeutics
Guidance to provide information on CTAP and EUA

This FDA guidance provides information on the Coronavirus Treatment Acceleration Program (CTAP) and currently authorized EUA Theerapeutics.

FDA COMBATING COVID-19 WITH THERAPEUTICS

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.

Notice: IRB Fees Memo

August 4th, 2020 - New IRB Fee structure effective Oct 1st, 2020. Read article for full details.

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