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.  

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The Department of Education has issued new regulations regarding Title IX that go into effect on August 14, 2020.

A Summary of the Major Provisions of the Title IX Final Rules can be found on the Office for Civil Rights, Department of Education, website at https://www2.ed.gov/about/offices/list/ocr/docs/titleix-summary.pdf.  

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


 

Resuming Human Subjects Research - Stage 2 Examples

GCCC Re-Open research plan FINAL

GCCC Clinical-Research-Resumption---Checklist-for-Resuming-FINAL-UMGCCC_06 30 20

HSF III User Procedure CTRIM human COVID19 v3

SON HS Research Resumption Process 7.14.20


 

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.


 

December 2020 - UMB's Resource Guide for Students on Sexual Misconduct has been updated and posted to the Title IX Resources and References page.

This resource contains information and definitions from UMB’s policies and procedures related to sexual misconduct, as well as information about on-campus and off-campus resources available to UMB students. This brochure also includes risk reduction information, general information and recommendations about what to do in the immediate aftermath of a sexual assault, and UMB’s procedures for responding to sexual misconduct.

Found here: Resources and References