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Human Research Protections
Within the Office of Accountability and Compliance

Archived Announcements

December 3rd, 2024 - UMB Research Compliance strategic plan related to human, animal and laboratory research Virtual Town Hall.

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: https://www.youtube.com/watch?v=ElJS-unR1aY

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

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.

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: 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: 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.

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.

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

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

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.

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.
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.

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!
February 2019 - HHS Posting

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

To View HHS Instructions click here. 

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.
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. 

 

CICERO New Login Instructions

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

Research Workshop

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

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.

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