Institutional Review Board (IRB)
For the protection of human participants in research
Changes to Human Subjects Regulations known as Common Rule took effect January 21, 2019
Changes to the human subjects regulations known as the Common Rule have now taken effect after a yearlong delay. The revised rule includes:
- new and expanded exemption categories,
- updated Approval Criteria including changes to criteria for waiving or altering informed consent and waiving documentation of consent,
- additional required elements of consent for non-exempt research (see our Consent Resources page),
- and changes to the continuing review requirements for research qualifying for expedited review under the Common Rule.
To comply with the revised requirements, Protocol Applications have been updated and are available on the IRB Forms page. Current protocol application materials must be utilized for any new protocol submissions.
PROTECTING HUMAN SUBJECTS IN RESEARCH
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 September 28, 2020FWA 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.