Past Announcements

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.