These videos are recordings of HRP Grand Rounds, Program Lectures, and HRP Webinars. They cover various topics related to the HRP program here at UMB.
HRP Recorded Lectures
Recorded HRPO Virtual Grand Rounds, Oct 30th, 2024
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
Recording Link: https://youtu.be/s9sT9YxlY-w
Slides: Relying IRB--What Needs to be Reported RNI Oct. 30, 2024
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
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
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
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.
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.
April 30th, 2024 12:00pm - Ethical Issues in Aging Research with Emphasis on Research Involving Older Participants with Diminished Capacity to Consent
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.
Held February 15th, 2024. Relying on External IRBs and Utilizing SMART IRB - Process and Procedures. Presentation by Dr. Julie Doherty.
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
Held April to April 2023-24. Tony Keys, Johns Hopkins University, explains the regulatory requirements related to clinical trials.gov and answers any questions you may have about common issues responsible parties encounter when using the system.
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
Held March 2, 2023, A Review of the Federal Regulations Pertaining to Research with Prisoners presented by Julia Gorey, JD, Department of Health and Human Services (HHS).
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.
November 22nd, 2022 - Cloud recording of the UMSON Research Seminar regarding the SMART IRB Process and External IRB Reliance at UMB.
View the recording - https://youtu.be/bKaOY7Dy5k0
Slides - https://www.nursing.umaryland.edu/media/son/research/SMART-IRB--Reliance-Overview--11.2022.pdf
September 19nd, 2017 - Recording of the Upcoming Changes to the Federal Regulations Governing Human Subjects Research at UMB. Presented by Julie Doherty
View the recording - https://youtu.be/FPNo9VuHsHI
Slides - HRPO Grand Rounds - 09.19.2017
September 19nd, 2017 - Recording of the ClinicalTrials.gov: Updated Requirements. Presented by Julie Doherty
View the recording - https://youtu.be/JvOYZF5g_iw
June 30th, 2016 - Recording of Reportable New Information: What You Need to Know. Presented by Julie Doherty
View the recording - https://youtu.be/ByYwS_Ruk50
Slides - Grand Rounds RNI Slides 6-30-2016
March 17th, 2016 - Recording of Integrating Quality Management into Research Activities. Presented by Julie Doherty
View the recording - https://youtu.be/qzn5m0kynEQ
Slides - Doherty Lecture 3-17-2016
February18th, 2016 - Recording of NHSR, Exempt, Expedited - What You Need to Know. Presented by Tara Catanzariti
View the recording - https://youtu.be/JmWUufrJ7jM
Slides - NHSR Exempt Expedited 2-18-2016
August 19th, 2015 - Recording of Consent or Not to Consent: That is the Question, Ethical Issues in Human Participant Research. Presented by Dr. Hirshon
View the recording - https://youtu.be/MGJrR0sPft8
Slides - Hirshon Lecture 8-19-2015
May 21st, 2015 - Recording of Ethics of BioBanking. Presented by Dr. Rosenthal
View the recording - https://youtu.be/XiD-v4mpgYo
Slides - Rosenthal Lecture 5-21-2015
April 27th, 2015 - Recording of Research Involving Prisoners. Presented by Dr. Archibald
View the recording - https://youtu.be/sqh2-SKsiJw
Slides - Archibald Lecture 4-27-2015