HRP Recorded Lectures

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.

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.

Human Research Protection Program Research Grand Rounds 
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. 

Recorded Webinar: Relying on External IRBs and Utilizing SMART IRB - Process and Procedures 
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 

Slides: Relying on an External IRB_Researchers Feb 2024

Recorded Webinars - Session I, II, III, IV, V, and VI: ClinicalTrials.gov Registration & Reporting Guidelines and Best Practices 
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

Recorded Webinar UMB Research Compliance Education - Research with Prisoners 
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.

Recorded Webinar Link

UMSON November Research Seminar: SMART IRB Process and External IRB Reliance at UMB 
November 22nd, 2022 - Cloud recording of the UMSON Research Seminar regarding the SMART IRB Process and External IRB Reliance at UMB.

HRPO Grand Rounds - Upcoming Changes to the Federal Regulations Governing Human Subjects Research 
September 19nd, 2017 - Recording of the Upcoming Changes to the Federal Regulations Governing Human Subjects Research at UMB. Presented by Julie Doherty

HRPO Grand Rounds - ClinicalTrials.gov: Updated Requirements 
September 19nd, 2017 - Recording of the ClinicalTrials.gov: Updated Requirements. Presented by Julie Doherty

View the recording - https://youtu.be/JvOYZF5g_iw 

HRPO Grand Rounds - Reportable New Information: What You Need to Know 
June 30th, 2016 - Recording of Reportable New Information: What You Need to Know. Presented by Julie Doherty

HRPO Lecture - Integrating Quality Management into Research Activities 
March 17th, 2016 - Recording of Integrating Quality Management into Research Activities. Presented by Julie Doherty

HRPO Lecture - NHSR, Exempt, Expedited - What You Need to Know 
February18th, 2016 - Recording of NHSR, Exempt, Expedited - What You Need to Know. Presented by Tara Catanzariti

HRPO Grand Rounds - Consent or Not to Consent: That is the Question, Ethical Issues in Human Participant Research 
August 19th, 2015 - Recording of Consent or Not to Consent: That is the Question, Ethical Issues in Human Participant Research. Presented by Dr. Hirshon

HRPO Grand Rounds - Ethics of BioBanking 
May 21st, 2015 - Recording of Ethics of BioBanking. Presented by Dr. Rosenthal

HRPO Grand Rounds - Research Involving Prisoners 
April 27th, 2015 - Recording of Research Involving Prisoners. Presented by Dr. Archibald