Human Research COVID-19 Guidance

IRB COVID-19 Guidance
October 18, 2022 

As COVID-19 evolves, Investigators conducting human research should stay informed of the latest information on COVID-19 in addition to university guidance and implications for research. This guidance will be updated as new information becomes available.

Investigators conducting human subjects research must consider the risk(s) to participants within the current COVID-19 environment.  Risk of exposure to COVID-19 resulting from participation in human research may arise when research procedures include face-to-face interactions with participants, physical presence of participants on Auburn University campus or research site, or other scenarios.  

Investigators with active IRB protocols and those that are submitting new applications to the IRB may need to submit modifications to approved protocols and/or provide additional information related to the current COVID-19 environment. 

Active Protocols: 

1. What should I do if I have an active IRB protocol that does not involve risk of exposure to COVID 19?
   
   Active IRB protocols where exposure to COVID-19 would not result from participation in the research may proceed as previously approved by the IRB. 

2. What should I do if I have an active IRB protocol that includes the risk of exposure to COVID-19?
   
   Principal Investigators with active IRB protocols, where exposure to COVID-19 may result from participation in the research, must ensure that their protocols include approved IRB COVID-19 precautions.  For investigators with existing COVID-19 precautions interested in updating their protocols to reflect the current Auburn University COVID-19 Precautions Matrix, submit a Modification Request Form. The modification request should include any revised study materials (i.e., consent documents).

Protocol Applications:

3. What should I do if I am submitting a protocol application to the IRB?
   
   Principal Investigators submitting protocol applications to the IRB must consider if the risk of exposure to COVID-19 could result from participation in the research.  If it is determined that exposure to COVID-19 is a potential risk to research participants based on the proposed procedures, the following items should be included in the protocol application
   (See Resource List below for assistance with developing IRB submissions):
   • list exposure to COVID-19 as a potential risk to participants,
   • include the risk category of COVID-19 (A, B, or C) as specified in the Auburn University COVID-19 Precautions Matrix,
   • describe precautions to address the risk of participant exposure to COVID-19 (use the current Auburn University COVID-19 Precautions Matrix for guidance), and
   • describe the risk and precautions in the consent documents, scripts, or other materials (e.g., the COVID-19 Precautions Matrix). 

Questions? Contact us at irbadmin@auburn.edu or 334-844-5966.

Resources for Investigators Related to COVID-19

Guidance on Human Research COVID-19 Precautions: Provides guidance on screening/rescreening, personal protective equipment, surface contact decontamination, and other information for investigators conducting human research involving the risk of exposure to COVID-19.

COVID-19 Information for Human Research Participants: Provides participants with general information on the risk of COVID-19 so they can decide whether they want to participate or continue participation in human research. This document should be attached to the consent document or provided to all participants on any protocol where there is a risk of exposure to COVID-19.

COVID-19 Sample Language for Informed Consent: Provides sample consent language and a template for the PI to include in the consent document or provide to all participants on any protocol where there is a risk of exposure to COVID-19.