COVID-19 Face-to-Face Research Restart Guidelines

North Dakota State University is committed to protecting the rights, safety and welfare of all individuals participating in NDSU research projects. These protections ensure that: risks to participants are minimized, risks are reasonable in relation to benefits, recruitment procedures are fair, subjects are sufficiently informed and able to make a voluntary choice, their privacy and confidentiality are respected, and extra protections are in place for vulnerable groups.


During the ongoing COVID-19 pandemic, additional precautions need to be taken to ensure that human subjects in research are protected. These guidelines are intended to help researchers identify best practices for conducting face-to-face (F2F) research at NDSU while minimizing the risks of infection by COVID-19.

NDSU Institutional Review Board (IRB) - COVID-19 Face-to-face Research Restart Guidelines

COVID-19 Screening Questions

If you have questions or concerns regarding these recommendations, please contact

Kristy Shirley (1-8995, kristy.shirley@ndsu.edu)

IRB Chair – Dr. Ben Balas (1-6105, benjamin.balas@ndsu.edu)

IRB Vice-Chair, Dr. Zoltan Majdik (1-8038, zoltan.majdik@ndsu.edu).

Institutional Review Board Guidance

03/17/2020

In light of the ongoing spread of COVID-19 in the United States, NDSU’s IRB is recommending the following guidance for human subjects research conducted by NDSU faculty, staff or students:

  1. The board recommends that researchers voluntarily suspend all in-person human subject research covered by an NDSU IRB protocol until further notice. This includes all research activities that involve face-to-face interaction between a researcher and a participant (recruitment, interviews, focus groups, laboratory studies).
  2. The board recommends that all researchers who can conduct their research virtually (online) switch to that format immediately.

    Per 45 CFR 46.108(a)(3)(iii), changes to protocols that are necessary to eliminate apparent immediate hazards to a subject may be made without prior approval by the IRB. This includes initiating online testing and the use of Skype or other software platforms to conduct interviews or focus groups in lieu of in-person methodologies.

    Within 72 hours of implementing these changes, a Protocol Deviation report must be filed outlining the rationale for the change(s), what change(s) have been implemented and how these changes will mitigate risk to the participant.

  3. We recognize some continuing participant testing may be deemed necessary. In these cases, adopt the accompanying protocol for screening potential participants for COVID-19, which is currently in use at Sanford Health.
  4. Researchers who are ill (including but not limited to COVID-19) should not interact with human subjects.
  5. Follow CDC guidelines regarding best practices for good hygiene (handwashing, covering coughs and sneezes, etc.) and maintenance of lab equipment (sanitization practices).
  6. Suspending human subjects testing may be disruptive to planned courses of study for graduate students. We strongly encourage research supervisors and student research committees to develop alternative plans for the completion of student projects to eliminate or minimize ongoing human subjects testing.

If you have questions or concerns regarding these recommendations, please contact

  • Kristy Shirley (1-8995, kristy.shirley@ndsu.edu)
  • IRB Chair – Dr. Ben Balas (1-6105, benjamin.balas@ndsu.edu)
  • IRB Vice-Chair, Dr. Zoltan Majdik (1-8038, zoltan.majdik@ndsu.edu)
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