Human Research COVID-19 Guidance

IRB COVID-19 Guidance
March 27, 2020 (updated April 22, 2020, June 4, 2020, and October 30, 2020)

As COVID-19 presents a new and evolving situation, 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 are encouraged, as appropriate to meet research objectives, to consider replacing in-person activities with remote activities, technology-assisted participant interactions, or other methods to reduce the risk of participant exposure to COVID-19.

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. 
  1. What should I do if I have an active IRB protocol that involves the risk of exposure to COVID-19, but I would like to temporarily suspend the research?

    Active IRB protocols where exposure to COVID-19 may result from participation in the research may be temporarily suspended by the principal investigator.  The principal investigator may suspend all work on the protocol or limit activities to those that do not involve interaction with human participants.  The principal investigator should notify the IRB of the temporary suspension by emailing IRBsubmit@auburn.edu and including the following information:  
    • PI Name
    • Protocol Number
    • Protocol Title
    • A statement that exposure to COVID 19 may result from participation in the research.
    • A statement that the PI desires to temporarily suspend research activities.
    • A statement that all protocol activities will be suspended or only activities that involve interaction with human participants will be suspended.

    Following temporary suspension of research activities and prior to continuing work on the project, investigators may need to address the risk of COVID-19 by submitting a modification request to the IRB. Please see the response to Question 3 below for information on what should be included in the modification request.
  1. What should I do if I have an active IRB protocol that involves the risk of exposure to COVID-19 and I would like to proceed with research activities at this time?

    Principal Investigators with active IRB protocols, where exposure to COVID-19 may result from participation in the research, must submit a modification request form to engage human participants in research activities.  The modification request should include the items listed below.

    If face-to-face interactions, physical presence, etc. are needed to meet the research objectives:
    (See the Resource List below for assistance with developing IRB submissions)  
    • include a justification for procedures that may expose participants to COVID-19,
    • include detailed information needed to assess the risk of COVID-19
    • include any additional precautions to reduce the risk of exposure to COVID-19, and
    • include new or updated consent documents, scripts, or other materials as needed to address the requested modification

    If remote activities or other methods may be substituted for face-to-face interactions, physical presence, etc.: 
    • describe the requested change to the approved protocol,
    • include a description of the new procedure, and
    • include new or updated consent documents, scripts, or other materials as needed to address the requested modification

Protocol Applications:

  1. 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 will need to 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,
    • justify the use of procedures which may result in risk of participant exposure to COVID-19,
    • include detailed information needed to assess the risk of COVID-19,
    • describe precautions (see Precautions for risk of exposure to COVID-19 below for more information) to address the risk of participant exposure to COVID-19, and
    • describe the risk and precautions in the consent documents, scripts, or other material

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 Considerations for Human Research: Provides questions for PIs to consider when developing new protocols or modifications for projects 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.