COVID-19 UPDATE: Human Subject Research – Important Additional Guidelines and Update
EDIT 4/28/2021: As of April 27, 2021, the Tiering system referenced in this post has been discontinued. Investigators are no longer required to make a Tiering determination for their studies.
IMPORTANT: Please read this announcement (issued 3/23/20) from Dr. Srirama Rao, Vice President for Research and Innovation, and Dr. Peter Buckley, Interim CEO, VCU Health System, Interim Senior Vice President, VCU Health Sciences, Dean, VCU School of Medicine, regarding important additional guidelines and updates related to human subjects research during the COVID-19 pandemic.
- Tier 1/ Tier 2 – Studies within Tier 1 or Tier 2 (those seeking to continue in-person visits/interactions) must follow the steps outlined in the announcement including submission of a justification through the VCU COVID-19 Human Research Continuation Request Portal. All justifications should have been submitted by Wednesday, March 25th. If you have not yet submitted a justification through the portal, you must do so immediately. Following submission to this portal, the PI’s Department Chair and Dean/Associate Dean for Research will review the justification for consideration of approval (by Friday, March 27, 2020). Please ensure completion of the processes outlined in the below notice for studies that you determine to fall in Tier 1 or Tier 2.
- New studies proposed during the COVID-19 pandemic that likely fit the description of Tier 1 or Tier 2 may be approved by the IRB, however, they may not begin to enroll participants until/unless cleared to do so via the VCU COVID-19 Human Research Continuation Request Portal.
- Tier 3/ Tier 4 studies should continue to follow previous OVPRI guidance from March 17, 2020.
Please review the notice in its entirety for additional requirements and information related to all four tiers. If you have questions about how this guidance affects your research, please contact the IRB Coordinator assigned to your study.
For the most up-to-date information regarding human subjects research, see the OVPRI COVID-19 Website and the Human Subject Research Protection (HRPP) Blog. Our COVID-19 and Human Research: FAQs page will also be kept up-to-date with new information as it is available.