Click here to download a full PDF of the SOM human subjects research guidelines. Please note, updates may be made frequently. Always reference the CRSO website to ensure you are working under the current version.

Click here to view the CRSO Town Hall recording from 6/4/2020 (Onyen login required).

HUMAN SUBJECTS RESEARCH

Summary of Changes:

Brief Description of Change Reason for Change Date
Added requirement to wear eye protection (in addition to mask) when interacting with subjects who cannot reliably wear masks To maintain alignment with UNC Health policies 5/28/2020
Removed all requirements related to measuring temperature (for participants and employees) To maintain alignment with UNC Health policies 6/5/2020
Added resources: 1) COVID-19 information review documentation template 2) Participant visit checklist template Provide additional resources 6/19/2020

 

The Office of the Vice Chancellor for Research (OVCR) will govern decisions regarding reopening UNC Chapel Hill and research operations. On May 23, 2020, Dr. Magnuson announced that starting June 1, 2020, UNC will begin increasing the amount of research conducted on our campus in a phased, careful and sustainable way.

This document describes processes and guidelines for conducting human subjects research for investigators and study teams within the UNC School of Medicine. Human subjects research studies wishing to initiate or resume activities going forward will be subject to guidelines established by the SOM.

  • Any individual who can effectively conduct their work remotely should continue to work remotely so as not to place themselves or others at unnecessary risk.
  • Please pay special attention to the requirements for wearing of face masks, physical distancing, hygiene and cleaning practices while on campus.
  • These principles must be followed at all times by faculty, trainees and other staff involved in University research.

Direct notice of updates and revisions to these guidelines will be disseminated via the CRSO list serv. If you would like to receive direct notice, you may subscribe to the CRSO list serv by clicking here. Updated documents and guidelines will also be posted on the this website. If you have questions related to the guidelines outlined in this document or otherwise related to conducting human subjects research in the context of COVID-19, please contact crso@med.unc.edu.

What you will find in this document:

  1. Direction and guidance for all on-campus research at UNC
  2. SOM general information related to human subjects research in the context of COVID-19
  3. Considerations for different types of human subjects research studies
  4. Specific procedures and guidelines for research studies involving direct contact
  5. General guidelines for worker safety
  6. Special considerations for field-based research

If everyone working in a research facility uses the described precautions, we will minimize risk of COVID-19 transmission and maximize prevention and safety. OVCR is working on a testing and tracing plan in place for researchers across the university. Speak up to your supervisor, department chair or center director if you observe someone not following such precautions. Individuals may report non-compliance by calling the Ethics Point Hotline at (866) 294–8688. We are all responsible for workplace safety and ensuring the safety of participants.