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.

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.

University of Maryland Baltimore Human Research Protections Program

SMART IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy (effective date: January 25, 2018). Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. Presentation by Dr. Julie Doherty.

Recording link: https://youtu.be/lQdrd8jp7So  

Slides: Relying on an External IRB_Researchers Feb 2024

Please join us!

University of Maryland Baltimore

Human Research Protection Program Research Grand Rounds (Virtual)

April 30, 2024     12:00-1:00pm

Title: Ethical Issues in Aging Research with Emphasis on Research Involving Older Participants with Diminished Capacity to Consent

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

Slides: Webinar Slides Ethical Issues in Aging Research 4-30-2024

Dr. Katzel is an associate professor of medicine in the Division of Gerontology, Geriatrics, and Palliative Medicine, Department of Medicine, University of Maryland School of Medicine; director of the Baltimore VA Medical Center Geriatrics Research, Education, and Clinical Center (GRECC); and co-principal investigator along with Drs. Alice Ryan and Jay Magaziner of the University of Maryland Claude D. Pepper Older Americans Independence Center. Dr. Katzel is a board-certified internist and geriatrician with fellowship training at Johns Hopkins and the National Institute of Aging/Gerontology Research Center. For the past 30 years he has been principal investigator or co-investigator on grants funded by the National Institutes of Health and U.S. Department of Veterans Affairs (VA) that focus on the performance of exercise and lifestyle interventions in older adults with numerous medical comorbidities including metabolic syndrome, chronic kidney disease, Parkinson’s disease, peripheral arterial disease, HIV, and stroke. He has published more than 160 journal articles and book chapters. Dr. Katzel also has a longstanding interest in research ethics and is chair of the VA Maryland Health Care System Research and Development Committee, chair of the University of Maryland Embryonic Stem Cell Research Oversight Committee, former chair and vice-chair of the UMB IRB. 

Session I:

Recorded Webinar Link: https://youtu.be/b4KZS-nNGYI 

Webinar Slides: Webinar Slides CT.gov Session I

Session II:

Webinar Slides: Webinar Slides CT.gov Session II

Session III:

Recorded Webinar Link: https://youtu.be/ajlOFcJDAvY 

Webinar Slides: Webinar Slides CT.gov Session III

Session IV:

Recorded Webinar Link: https://youtu.be/BLLD7uNE0Go 

Webinar Slides: Webinar Slides CT.gov UMB Session IV

Session V:

Recorded Webinar Link: https://youtu.be/_O8VOHFr3Ww

Session VI:

Recorded Webinar Link: https://youtu.be/2VDPVjuAM_U

Title: A Review of the Federal Regulations Pertaining to Research with Prisoners.

Speaker: Julia Gorey, JD

Julia Gorey serves as a Policy Analyst in the Office for Human Research Protections, Division of Policy, Department of Health and Human Services (HHS), and is charged with writing and interpreting guidance and policy for 45 CFR part 46, the HHS regulations for the protection of human subjects in research. In addition to general responsibilities, she oversees the administration of subpart C and the review and authorization of human subject research involving prisoners; she also serves as Executive Director of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which provides expert advice and recommendations to the Secretary, HHS, on issues relevant to research involving human subjects with a particular emphasis on vulnerable populations. She is a University of Maryland Francis King Carey School of Law alumnus.

Recorded Webinar Link

View the recording - https://umaryland.zoom.us/rec/share/Uci8G92eInCBSU5dUpQa5r50BgBoK7XS3ubbULHoB7GGok9_ngh1FO1dMM9zAe-B.ZOB5SYuiSNZ7gCcJ

Passcode = P%a?xa5!

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

FDA COMBATING COVID-19 WITH THERAPEUTICS

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