Announcement - Effective June 21st, Human Subjects Research Moves to Stage 3 of Resumption Plan. Expand for Checklist
June 9th, 2021 - The decision to move to Stage 3 of the Human Subjects Research Resumption Plan will be effective on June 21st, 2021. Expand for Guide and Checklist.

Resumption Plan - Guidelines | Resumption Plan - Process | Resumption Plan - Checklist 

 

June 9, 2021

Dear UMB Researchers,

We are pleased to announce the following updates regarding research operations effective on June 21, 2021:

Campus Research Not Involving Human Subjects:  Laboratory-based research will be increased to 100% occupancy with no physical distancing requirements inside laboratories. Masks will continue to be required in the laboratory setting.  UMB physical distancing requirements for spaces outside of laboratories including conference rooms and break areas are still in effect.

Community-based Research: The current exclusion of Category D research in community settings will be lifted, with Stage 3 community-based research allowed to resume.  Researchers must follow all guidelines set by the collaborating entity (e.g., nursing home, school, community center, etc.). A letter from the collaborating entity stating that researchers are permitted to conduct studies in their facilities is required to be included as supporting documentation  in a Reportable New Information (RNI) submission for the study, along with the required checklists found above.

Clinical Research and Other Campus Research Involving Human Subjects: Researchers conducting human subjects research will abide by the current University of Maryland Medical System (UMMS) guidelines for conducting clinical research.  UMMS guidelines currently state that researchers must wear masks, regardless of vaccination status, unless they are alone in their work space. There is no density requirement, but researchers should practice physical distancing where possible.

As COVID-19 case numbers continue to decline and the rate of vaccination continues to increase, we are pleased to move a step closer toward normal operations.  Information on COVID-19 vaccine requirements and where to get a COVID-19 vaccine can be found on UMB’s COVID 19 Vaccine webpage.

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

Smart IRB Logo

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)


 

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.

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.