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COVID-19 Resources

Northwestern University is actively monitoring the COVID-19 pandemic, with particular focus on the health and well-being of the university community, as well as on the continuity of university operations. This page contains resources and guidance that can used to conduct human subjects research during this time. This page is routinely monitored and updated, and all members of the Northwestern community are advised to check back regularly for new information.

Northwestern COVID-19 Resources

IRB COVID-19 Resources

COVID-19 Symptom Pre-Screener

Researchers who are not conducting study visits at a clinical facility may use this pre-screening tool. Researchers conducting study visits at a clinical facility should use the hospital/clinic’s screening protocol.

Considerations When Eligibility Criteria May Require COVID-19 Vaccination/Testing

Researchers proposing to list COVID-19 vaccination and/or testing as  part of eligibility criteria must provide scientific justification in order to add this requirement to any research study.

Notification of Close Contact to COVID-19 in a Research Setting

The following notification templates have been created for Principal Investigators and their research team members to use in the scenario when a research participant has come into close contact with a study team member during a study visit in a non-clinical setting, and after which that study team member has tested positive for COVID-19.

This notification is in an effort to be diligent as well as courteous in informing our research participants. The IRB Office recommends notifying research participants via a confidential phone call, followed by a mailed letter (on a departmental letterhead) or secure email to the research participant. 

If the research visit took place at a clinical affiliate or other clinical setting, please follow the respective clinic/hospital policy on notification. Please note that, if the research visit took place in the clinical (healthcare) setting where the appropriate PPE is consistently used and has been proven effective in reducing risk of COVID exposure, the definition of close contact as described in the template script would not apply.

IRB-Related News and Memos

January 27, 2022

  • Considerations When Eligibility Criteria May Require COVID-19 Vaccination/Testing  - See above

January 23, 2022

  • COVID-19 Pre-Screener (v01-23-2022)  - See above

June 21, 2021

July 09, 2020

June 19, 2020

May 22, 2020

March 12, 2020

Tips for Performing Virtual/Remote Human Subjects Research

General Study Management:

  • Conduct virtual study visits through Zoom or other Northwestern IT verified platforms
  • Convert paper questionnaires to electronic form – utilize services such as REDCap or Qualtrics for data collection
  • Submit modifications in eIRB+ to existing studies to allow for a Waiver or Alteration of the Consent Process and/or a Waiver of Documentation of Consent if the study can no longer be practically carried out without written consent

Record Keeping:

  • Ensure that private/confidential documents are saved on secure Northwestern devices and servers – do NOT save any study-related documentation to your personal devices
    • See NUIT’s guidance on protecting research records here
  • If a study is conducted without a Waiver of Documentation of Consent, consider utilizing a Documentation of Consent Process form to fully document the written consent process
    • If a study is using online/verbal consent, the consent process must still be documented
    • Resources for documenting consent and other study activities can be found on the IRB Website under Study Support Resources and Templates

Federal Guidance on COVID-19