For the protection of human research participants
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:
- 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).
- 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.
- We recognize some continuing participant testing may be deemed necessary. In these cases, adopt the accompanying protocol (see below) for screening potential participants for COVID-19, which is currently in use at Sanford Health.
- Researchers who are ill (including but not limited to COVID-19) should not interact with human subjects.
- Follow CDC guidelines regarding best practices for good hygiene (handwashing, covering coughs and sneezes, etc.) and maintenance of lab equipment (sanitization practices).
- 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, email@example.com)
IRB Chair – Dr. Ben Balas (1-6105, firstname.lastname@example.org)
IRB Vice-Chair, Dr. Zoltan Majdik (1-8038, email@example.com).
North Dakota State University is committed to protecting the rights, safety and welfare of all individuals participating in NDSU research projects. Research with human subjects is conducted in accordance with regulations of the Dept. of Health & Human Services, Food and Drug Administration, and other applicable agencies (see NDSU Policy #345). 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.
NDSU holds an approved FederalWide Assurance (FWA) with the Office of Human Research Protections (DHHS). #FWA00002439 Expires July 19, 2023 FWA Terms.
The terms of the FederalWide assurance (FWA) require the NDSU Institutional Review Board (IRB) to review or certify all human subjects research prior to initiation to ensure protection of participants’ rights and welfare. The IRB is comprised of NDSU faculty, student members, and members not otherwise affiliated with the university. Members possess varying experience and expertise in order to review the types of research conducted at NDSU. IRB Members are appointed by the Vice President for Research and Creative Activity who serves as the Institutional Official. The board is also responsible for oversight of ongoing research, resolving participant concerns or complaints, reports of noncompliance, and providing education and guidance on research participant protections to the NDSU research community.