Archived Announcements
TO: UMB Research Community:
A virtual town hall will be held for the UMB research community to provide feedback on the goals of the UMB Research Compliance strategic plan related to human, animal and laboratory research. Attendees may pose questions or comments personally or anonymously. This listening opportunity is designed for your voice to be heard!
Dr. Robert Rosenthal, Assistant Vice Provost Research Compliance and Dr. Julie Doherty, Assistant Vice President, Research Compliance, will be there to facilitate. We are looking forward to your participation !!
Link to recording:
Date: December 3, 2024
STRATEGIC GOAL 1: An efficient and effective research compliance program of the highest standards
STRATEGIC GOAL 2: Comprehensive educational opportunities for all
STRATEGIC GOAL 3: An inclusive and engaged research community
STRATEGIC GOAL 4: Innovative research enterprise
STRATEGIC GOAL 5: Ethical and compliant global research engagement
STRATEGIC GOAL 6: Security and Integrity of Research Data
Announcement - Revisions to Informed Consent and HIPAA Authorization Form Template
Announcement - Effective June 21st, Human Subjects Research Moves to Stage 3 of Resumption Plan. Expand for Checklist
REMINDER: FDA Compliance with ClinicalTrials.gov
Announcement - Human Subjects Research Resumption Update
Update to Announcement - Human Required Reliance Process Training for PIs
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
Announcement - MUST READ - Memo from IO to PIs Regarding Expired Studies
Announcement: UMB Research Community - COVID-19 Risk Statement for Human Research Participants
Reminder - Human Subjects Research Remains in Stage 2 of Resumption Plan
This FDA guidance provides information on the Coronavirus Treatment Acceleration Program (CTAP) and currently authorized EUA Theerapeutics.
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
Notice: IRB Fees Memo
FDA Guidance on Conduct of Clinical Trials during COVID-19: For Industry, Investigators, and IRBs
Updated July, 2nd, 2020 of original March 2020 Guidance.
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.
COVID-19 Human Research Coordinating Committee - Update 2 (IO)
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. .
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. .
Webinar: UMB Human Subjects Research - Q&A Session
Proposed or Planned COVID-19 Human Subjects Research Protocols
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
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
February 2019 - HHS Posting
Clinical Trial Posting of Informed Consent Documents Under the Revised Common Rule.
To View HHS Instructions .
HHS Announcement, Single IRB and Cooperative Research
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
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.
CICERO New Login Instructions
Research Workshop
FDA Guidance:
IRB waiver or Alteration of the Informed Consent
Click for details:
NIH implements a series of clinical trials reforms. Effective 1-25-2018
Click for details: CT.GOV Information