Past News

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


 

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.


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.

2019 Ethics Week Celebration 

November 4th-9th, 2019

This is a time for organizations of all types and sizes to spotlight the efforts and actions that create and reinforce a culture of compliance.


 

UMB Notice: NIH Training Applications

March 7th, 2019

NIH Notice: NOT-OD-19-029 - Harassment and Discrimination Protections in NIH Training Applications.


 

How to Report Discrimination or Bias 

March 6th, 2019

Information and Contacts for reporting misconduct related to Discrimination or Bias.