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.
NIH recently released guidance and sample consent language for protecting the privacy and respecting the autonomy of participants when sharing data or biospecimens for future research. The document provides modifiable sample language that investigators and IRBs can use to clearly communicate potential risks and benefits associated with data/biospecimen storage and sharing for future research.
As we all find ways to regain normalcy in a world with COVID-19, the NDSU IRB has transitioned its guidelines for preventing the transmission of COVID-19 in face-to-face research to "Risk Mitigation Strategies for Infectious Illness." This one-page document outlines basic strategies to decrease the risk of transmitting infectious illnesses (e.g. influenza, COVID, and even the common cold) while still actively pursuing face-to-face research opportunities.