Past Announcements

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 Webinar: 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. 

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, V, and VI: 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://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.

REMINDER: FDA Compliance with ClinicalTrials.gov

April 19th, 2022 - The UMB Office of Accountability and Compliance (OAC) and the IRB are once again asking researchers who are subject to the CT.GOV regulations to log in to clinicaltrials.gov and check for problems with their records.

Announcement - Human Subjects Research Resumption Update

March 16th, 2022 - Memorandum to UMB Research Community, update to resumption of research requirements pertaining to COVID.

Update to Announcement - Human Required Reliance Process Training for PIs

April 22th, 2022 - UMB’s Human Research Protection Program (HRPP) has updated their Reliance Agreement documentation and requirements. UMB investigators read to see if you need to complete and how to access the training.

Announcement - Principal Investigator Responsibilities Brochure Release

January 18th, 2022 - HRPO releases the Principal Investigator Responsibilities Brochure to help PI's prevent protocol expiration. Download or find on Study Conduct webpage. 

Principal Investigator Responsibilities Brochure


 

Announcement - Required PI Training Regarding Expired Studies

November 19th, 2021 - Communication from Institutional Official to Principal Investigators about required training on their responsibilities for maintaining study approval and the consequences for allowing IRB approval to expire.

Announcement - MUST READ - Memo from IO to PIs Regarding Expired Studies

October 25th, 2021 - Communication from Institutional Official to Principal Investigators regarding their responsibilities regarding expired studies.

Announcement - Effective June 21st, Human Subjects Research Moves to Stage 3 of Resumption Plan. Expand for Checklist

June 9th, 2021 - The decision to move to Stage 3 of the Human Subjects Research Resumption Plan will be effective on June 21st, 2021. Expand for Guide and Checklist.

Reminder - Human Subjects Research Remains in Stage 2 of Resumption Plan

December 17th, 2020 - The decision to move to Stage 2 of the Human Subjects Research Resumption Plan was announced August 25th, 2020 and remains in place.

FDA Guidance Oct 2020 - Combating COVID-19 with Therapeutics 
Guidance to provide information on CTAP and EUA

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

FDA COMBATING COVID-19 WITH THERAPEUTICS

Announcement: UMB Research Community - COVID-19 Risk Statement for Human Research Participants

21 September 2020: The UMB COVID-19 Risk Statement provides the research community with the standardized COVID-19 risk language to share with research participants, or their Legally Authorized Representative (LAR) who are scheduled to visit the UMB campus and/or its affiliated off-campus sites.

Resuming Human Subjects Research, June 23, 2020 - Guidelines, Process, Checklists

The UMB COVID 19 Research Advisory Task Force was charged with developing guidance for restarting research considering the ongoing pandemic. This guidance provides a tiered, staged approach for resuming human subjects research activities, responding to the varied need for personal contact, physical space, and the ability to maintain personal and environmental safety precautions.

Resumption Plan - Guidelines   |  Resumption Plan - Process  |  Resumption Plan - Checklist  |  Resumption Plan - Assessment Questions


 

Recorded Q&A Session from July 17th, 2020 
UMB Guidelines for Resuming Human Subjects Research

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

Notice: IRB Fees Memo

August 4th, 2020 - New IRB Fee structure effective Oct 1st, 2020. Read article for full details.

FDA Guidance on Conduct of Clinical Trials during COVID-19: For Industry, Investigators, and IRBs

Updated July, 2nd, 2020 of original March 2020 Guidance. Read full guidance here.


 

New COVID-19 Research Involving Humans Information Section

11 May 2020, This section provides information on UMB’s Committees and Task Forces convened in response to the COVID-19 pandemic and human subjects research arising in response, the Biospecimen Repository being created under an umbrella protocol, COVID-19 Clinical and other Trials, and provides a FAQ for the research community.

FDA Guidance May 2020 - COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

13 May 2020,  - The FDA is issuing this guidance to assist sponsors in the clinical development of drugs for the treatment or prevention of COVID-19. Click to read FDA guidance.


FDA Guidance May 2020 - COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products

13 May 2020,  - FDA is issuing this guidance to provide general considerations to assist sponsors in preparing pre-investigational new drug application (pre- IND) meeting requests for COVID-19 related drugs1 for the duration of the COVID-19 public health emergency. Click to read Pre-IND guidance.


COVID-19 Human Research Coordinating Committee - Update 2 (IO)

12 May 2020 - To the UMB Research Community, The COVID-19 Human Research Coordinating Committee continues to meet weekly to collaborate on a comprehensive and coordinated research response to the COVID-19 pandemic.

Webinar: UMB Human Subjects Research - Q&A Session

April 14th, 2020, 11:00am - Session focused on providing guidance and information, as well answering questions, regarding human subjects research under UMB’s COVID-19 pandemic guidelines. Open Full Article to view Recording of session.

Proposed or Planned COVID-19 Human Subjects Research Protocols

10 April 2020, COVID-19 human subjects research protocols proposed or planned will be subject to a preliminary review to allow for prioritization and efficient processing. Click Title for full article and the required Worksheet

Temporary Modifications to the Research Study Participant Payments Procedure

6 April 2020, the State of Maryland and UMB Financial Services – Disbursements continue to process payment requests in accordance with established regular payment processing requirements. The temporary modifications described below are effective until the UMB COVID-19 Telework Policy is lifted. Click to read announcement.


FDA COVID-19 NEWS RELEASE - Updated March 27, 2020

 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19


FDA NEWS RELEASE - Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials

March 18, 2020  To access news release click here


UMB IRB and HRPO Guidance Regarding COVID19 and Conduct of Research

March 12, 2020  All Researchers - Please read the attached document for guidance regarding COVID-19 and the responsible conduct of active research. UMB IRB and HRPO Guidance Regarding COVID19 and Research


OHRP - New Lecture Video on e-Consent

OHRP Newsletter February 2020. OHRP is excited to announce that a new informative video on e-Consent is now available to the research community!

HHS Announcement, Single IRB and Cooperative Research

HHS Announcement Nov. 21st, 2019 - Determination of Exception to the Required Use of a Single IRB for Certain HHS Cooperative Research that is Subject to the 2018 Requirements.

February 2019 - HHS Posting

Clinical Trial Posting of Informed Consent Documents Under the Revised Common Rule.

To View HHS Instructions click here


New: Common Rule Revisions Courses

These ~30 minute online courses cover the Common Rule revisions governing human subjects research that were implemented on January 21, 2019. General, Exemptions, Informed Consent, etc.

To View Courses.


 

New Common Rule Revisions

The New Common Rule revisions to the regulations governing human subjects research are due to go live on January 21, 2019.

New: A Clinical Trials.gov Checklist

A checklist has been developed for UMB Researchers! Click CT.GOV Information to download the checklist from the resources page. 


 

Research Workshop

Special Workshop on Making Payments to Research Study Participants, April 24, 2019, 10:00 – 12:00, SOP Room N203

CICERO New Login Instructions

NEW!! The way you log on to CICERO will change on Tuesday, Sept. 25, 2019

FDA Guidance:

IRB waiver or Alteration of the Informed Consent

Click for details: FDA Guidance

NIH implements a series of clinical trials reforms. Effective 1-25-2018

Click for details: CT.GOV Information

NIH released a policy on Good Clinical Practice (GCP) Training for NIH Awardees involved in NIH-funded Clinical Trials

This policy went into effect on Jan. 1, 2017. NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials are required to be trained in GCP.