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.
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.
March 7th, 2019
NIH Notice: NOT-OD-19-029 - Harassment and Discrimination Protections in NIH Training Applications.
March 6th, 2019
Information and Contacts for reporting misconduct related to Discrimination or Bias.