INTRODUCING - UMB IRB Chair and HRPO/IRB Virtual Office Hours 
This is an opportunity for the research community to speak directly to the IRB Chair and a member of the HRPO/IRB staff!! The 2nd Monday of every month from 12n to 1pm.

Questions???    Ask the Chair and HRPO Staff!

This is an opportunity for the research community to speak directly to the IRB Chair and a member of the HRPO/IRB staff!!

2nd Monday of every month from 12n to 1pm.

First session:   This Monday, October 14, 2024

Link:  https://umaryland.zoom.us/j/95695695923?pwd=RNkVmEbTox7fbjGaTqGORBojpXAGqJ.1

(no RSVP required)

Announcement: HRPO Virtual Grand Rounds: Single IRBs: What Needs to be Reported to UMB When Relying on an External IRB 
HRPO Virtual Grand Rounds, Oct 30th, 2024, 12:00 to 1:00 pm

Please join us!!

University of Maryland Baltimore

Human Research Protections Program

Virtual Grand Rounds:

Single IRBs:  What Needs to be Reported to UMB When Relying on an External IRB

Presenter:  Julie Doherty, DM, MSN, RN, CIP, CCEP

Assistant Vice President, Research Compliance

October 30, 2024

1pm to 2pm

Link: https://umaryland.zoom.us/j/98449207979?pwd=JiHi8zuxCpoZNdCj84eltm8XzY8lJL.1 

(no RSVP required)

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 provides up-to-date information related to conducting research with human participants.


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.     Dr. Buskirk's IO Appointment Letter

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)

Recorded Webinar: HRPO Virtual Grand Rounds: After IRB approval--What Needs to be Reported to the UMB IRB? 
HRPO Virtual Grand Rounds, Oct 10th, 2024, 1:00 to 2:00 pm

Please join us!!

University of Maryland Baltimore

Human Research Protections Program

Virtual Grand Rounds

After IRB approval--What Needs to be Reported to the UMB IRB?

(A Review of UMB IRB HRPP Reportable New Information Submission requirements)

Presenter:  Julie Doherty, DM, MSN, RN, CIP, CCEP

Assistant Vice President, Research Compliance

October 10, 2024

1pm to 2pm

Recording Link: https://youtu.be/DlEqcpZgLOA

Slides: Recorded Webinar Slides - Oct 10th, 2024 Grand Rounds

Recorded Webinar: HRPP Research Grand Rounds & SOCRA Baltimore 
May 30th, 2024 12:00pm - PI and Study Staff Considerations for QA/Monitoring

Please join us!

5/30/2024 Seminar 12pm-1pm Virtual (Zoom)- Registration Required

Presentation:   PI and Study Staff Considerations for QA/Monitoring

Presenter:                         

Jill Kessler MS, MSL, CCRP

Senior Research Monitor

Johns Hopkins University

Learning Objectives:

  • Essential document review and importance during life of study
  • Preparing for a successful remote site visit
  • Common findings during IMVs and how to prevent (or resolve)

Recording Link: https://youtu.be/X_ZAzCZH_0E

Slides: Recorded Webinar Slides - May 30th, 2024 GR and SOCRA

Regards, 

Casey Jackson, MS, CCRP (she/they) 

Director, Research Quality Improvement and Compliance

Baltimore SOCRA Chapter Chair 

SOCRA National Board Director 

Recorded Webinar: Human Research Protection Program Research Grand Rounds 
May 29th, 2024 2:00pm - Focus on the UMB IRB: Survey Results and Plans for Improvement

Please join us!!

UMB Human Research Protections Program Virtual Grand Rounds

UMB Research Compliance Coordinating Council Survey: Focus on the UMB IRB: Survey Results and Plans for Improvement

May 29, 2024  2pm-3pm

In the early Fall 2023, a survey was conducted that included a request for feedback on the UMB Institutional Review Board. This session will provide summary information on IRB survey feedback along with IRB plans for improvement in processes and procedures. Q&A session will be included.

Recording Link: https://youtu.be/wAqWRkUoLPA

Robert Rosenthal, MD, Assistant Provost, Research Compliance

Julie Doherty, DM, MSN, CIP, CCEP, Assistant Vice President, Research Compliance

Jon Mark Hirshon, MD, PhD, UMB Institutional Review Board Chair

Jan Martinez, MS, CIP, CLSSGB, UMB Institutional Review Board Manager

Recorded Webinar: Human Research Protection Program Research Grand Rounds 
May 16th, 2024 12:00pm - Using the Secure Research Environment (SRE) in UMB Research Activities

University of Maryland Baltimore

Human Research Protection Program Research Grand Rounds (Virtual)

May 16, 2024     12:00-1:00pm

Title: Using the Secure Research Environment (SRE) in UMB Research Activities

Recording Link: https://youtu.be/PMucOAPhBi0     

Presenter: Dr. Peter Murray, Senior Vice President,  Information Technology and Chief Information Officer

The Secure Research Environment (SRE) is a new University virtual environment designed to protect sensitive and restricted research data from misuse and unauthorized access.  The SRE is different from the current UMB research computing environment in that the computing resources, data storage and software are not located on a local desktop or laptop computer but are available in a secure Cloud infrastructure. The SRE minimizes risk to the institution and to the principal investigator of an unlawful exposure of sensitive data.

Recorded Webinar: Human Research Protection Program Research Grand Rounds 
May 15th, 2024 12:00pm - Down with GCP? Yeah, you know me!

University of Maryland Baltimore

Human Research Protection Program Research Grand Rounds (Virtual)

May 15, 2024     12:00-1:00pm

Title: 

Down with GCP? Yeah, you know me!

Recording Link: https://youtu.be/LVym_lMYQgU      

Slides: Webinar Slides May 15th, 2024 - Down with GCP? Yeah, you know me! 

Presenter: Jessica Rowe, MA, MS, CCRP, CIP

Director of Quality and Education, Yale Cancer Center, Clinical Trials Office

 

Good Clinical Practice (GCP) is a set of internationally recognized ethical and scientific quality standards that guide the design, conduct, recording, and reporting of clinical trials involving human subjects. Adherence to GCP ensures the protection of participants' rights, safety, and well-being, as well as the reliability and integrity of data generated in the trial. The 13 Principles of Good Clinical Practice provide a comprehensive framework for conducting clinical trials responsibly and ethically. Ms. Rowe will provide an overview of these principles and their relevance to the Institutional Review Board (IRB), sponsor, and investigator responsibilities, with a particular emphasis on investigator-initiated trials and the informed consent process.

 

 

Jessica Rowe, MA, MS, CCRP, CIP is an expert in clinical research and human subject protection. She currently serves as the Quality and Education Director for the Yale Cancer Center Clinical Trials Office, where she oversees quality and education initiatives in clinical research. Previously, Jessica was the Associate Director for Regulatory, Compliance, and Quality at the Yale Center for Clinical Investigation and Yale Human Research Protection Program.

Before her tenure at Yale, Jessica was the HRPP Director for WellSpan Health, where she managed a comprehensive Human Research Protection Program. Her career began at the University of Maryland, Baltimore (UMB), where she worked for 13 years in various research roles and served on several research review committees. Currently, Jessica is an Institutional Review Board (IRB) member for both the University of Maryland, Baltimore and Yale IRBs.

Jessica is actively involved in professional organizations, serving as Chair of the Southern Pennsylvania Society of Clinical Research Associates (SOCRA) Chapter and as a SOCRA Board member and President. She is also an adjunct instructor at the University of Maryland, Baltimore Graduate School, where she teaches courses in research compliance and administration. In addition, Jessica participates as faculty in several SOCRA workshops on topics such as quality management, Good Clinical Practice (GCP), and decentralized clinical trials.