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 new and on-going research be conducted virtually (online) when possible.
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).
If Face-to-Face Interaction is required, the board recommends screening all participants and any family member/guardian accompanying the participant.
1. Do you have any of the following symptoms, or pending COVID-19 test because you were having any of the below symptoms?
• Body aches
• Shortness of breath
• Sore throat
• New onset loss of smell or taste
• New onset of vomiting or diarrhea
2. Do you have a pending COVID-19 test without any of the symptoms previously mentioned?
3. In the last 14 days, have you been exposed to anyone with a lab confirmed COVID-19 test or have you had a COVID-19 positive test result?
Anyone responding "yes" to any of the three questions should be excluded.
For Research/Lab Personnel, report any symptoms, exposures, pending or positive test results to the PI. Lab personnel reporting symptoms or potential exposures should self-isolate per the CDC guidelines for Discontinuation of Isolation for Persons with COVID -19 Not in Healthcare Settings.
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.