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 University: COVID-19 and Campus Updates
- Northwestern Medicine: COVID-19 Resource Center
- Feinberg School of Medicine: Coronavirus/COVID-19 Updates
- Ann and Robert H. Lurie Children's Hospital of Chicago: Novel Coronavirus (COVID-19) Resources
- Shirley Ryan AbilityLab: COVID-19 Updates
Researchers who are not conducting study visits at a clinical facility must use this pre-screening tool. Researchers conducting study visits at a clinical facility should use the hospital/clinic’s screening protocol.
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.
- Close Contact COVID Exposure Notification Template - Letter or Email
- Close Contact COVID Exposure Notification Template -Phone Script
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
- IRB Office Guidelines for Return of Human Research Activities to Campus (Updated)
- COVID-19 Pre-Screener (v06-19-2020)
May 22, 2020
March 12, 2020
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
- Platforms such as Amazon Mechanical Turk (Mturk) can be used for task research
- 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
- 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