New COVID-19 Research Involving Humans Information Section

11 May 2020, This section 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.

Human Research Protections (HRP) is a comprehensive program that affords protections for all human research participants and is under the direct leadership of the executive vice president and provost. 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 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.

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

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.