Human Research Protections

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.

Link: https://umaryland.webex.com/umaryland/j.php?MTID=ma08dfef264651eb8670071435d57557b

Presenters:

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

Human Research Protection Program 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)

Register here: https://umaryland.zoom.us/meeting/register/tJMsde6vqz0sHtOB8UeORM6Ix6AQTuieLl0C

Regards,

Casey Jackson, MS, CCRP (she/they)

Director, Research Quality Improvement and Compliance

Baltimore SOCRA Chapter Chair

SOCRA National Board Director

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)

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://umaryland.webex.com/umaryland/ldr.php?RCID=986c906167131a923c589eeb60a1e466

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://umaryland.webex.com/umaryland/ldr.php?RCID=0e2b93894c5abab7dfa347a0dfe73e91

Slides: Relying on an External IRB_Researchers Feb 2024

Announcement - Revisions to Informed Consent and HIPAA Authorization Form Template

Effective December 4th, 2023, the University of Maryland Baltimore Human Research Protections Program (HRPO) will adopt a revised version of the informed consent document (ICF) template.

Recorded Webinars - Session I, II, III, IV, and V: ClinicalTrials.gov Registration & Reporting Guidelines and Best Practices ▾
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://umaryland.webex.com/umaryland/ldr.php?RCID=eda6b84a72c906535e6fada7b0382bf3

Webinar Slides: Webinar Slides CT.gov Session I

Session II:

Webinar Slides: Webinar Slides CT.gov Session II

Session III:

Recorded Webinar Link: https://umaryland.webex.com/umaryland/ldr.php?RCID=86197e3a6b37f4aef42d767fe7c62314

Webinar Slides: Webinar Slides CT.gov Session III

Session IV:

Recorded Webinar Link: https://umaryland.webex.com/umaryland/ldr.php?RCID=ced442327142705cc607f1e2df1be144

Webinar Slides: Webinar Slides CT.gov UMB Session IV

Session V: