Institutional Review Board (IRB)
For the protection of human participants in research
Upcoming changes in Human Subject's Protections
New standard operating procedures, protocol applications, forms, and templates have been drafted to comply with the revised Common Rule which will take effect January 19, 2018. The revised Common Rule expands the types of research which will qualify for an exemption, provides a limited review process for some exempt research, alters requirements for continuing review, and implements new standards for informed consent. Currently active expedited protocols will transition to the new rule as they come due for Continuing review. At that time, some protocols may be transitioned into one of the new Exemption Categories by completing a new Protocol Application for Exemption.
Ongoing non-exempt research studies which are still open to enrollment must adapt Consent form(s) to meet the new consent requirements. An updated Consent Template is available on the Forms page of the IRB website under the Templates Section.
New non-exempt protocol submissions should begin using the new Consent Template.
More information about these changes can be found on the Resources page.
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.