Institutional Review Board (IRB)
For the protection of human participants in research
Delay in revised Common Rule Implementation
The Federal Register has published the "Delay of the Revisions to the Federal Policy for the Protection of Human Subjects". Officially scheduled to be published 1/22/2018, this delays the effective date and general compliance date of the revised common rule to July 19, 2018, six-months after the original date of January 19, 2018.
We will continue to utilize the revised consent template for non-exempt research which was developed in response to the changes; however, we will be unable to utilize the additional exemptions or the changes to continuing review processes for research qualifying for Expedited review until the July effective/compliance date.
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.