For the protection of human research participants
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.
New Protocol submissions are now required to be submitted via the Novelution Institutional Review Board (IRB) module. Protocols originally submitted using the previous IRB forms, will continue to use "Legacy forms" for Amendments, Continuing Reviews, Personnel additions, etc. Legacy Forms can be found on the Forms page.
- Click here for more information about the Novelution platform or to view recorded demonstrations of the software.
- Click here to log in to Novelution.
- Tutorial - Creating an IRB Protocol Application
- CITI Integration - Novelution automatically integrates with the CITI program to verify completion of human subjects training. To ensure accurate reporting of your completed training, ensure that the email address in your Novelution Profile, and the email address in your CITI profile match. Your Novelution profile is set by the University System and can be found by clicking on 'Profile & Settings' > Edit User Profile. For most faculty, staff and students, this email will by firstname.lastname@example.org; however, if you have another affiliation within the NDUS system (e.g. you are a student at another institution), the domain may be the institution at which you are a student.
- Wondering the status of your IRB submission? - Check the Requirements panel within the Protocol application to check on the current status of the protocol submission.
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.
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 using the above screening tool.
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.