The University of Nebraska–Lincoln research community is urged to start preparing for major changes to regulations governing human subjects research, as outlined in Common Rule 45 CFR 46. Registration is now open for fall training sessions.
Faculty and staff are encouraged to visit the Institutional Review Board’s Common Rule website, a comprehensive resource for navigating these changes and registering for the training sessions.
The amended rules, expected to become effective Jan. 19, 2018, are the first significant changes to human subjects regulations since 1991. While some Common Rule changes will reduce the burden on researchers and institutional compliance areas, many of the new requirements come with additional responsibilities.
Campus training sessions
Research Compliance Services is offering training sessions throughout the fall to educate researchers about the impact of Common Rule changes and ease the process of complying with the changes. The training also will address important changes to the IRB application system in NUgrant. Advance registration is encouraged for these sessions:
Sept. 21, 9 to 10:30 a.m., Jackie Gaughan Multicultural Center, Unity Room. Register here.
Oct. 20, 2 to 3:30 p.m., East Union, Arbor Suite. Register here. Details on a live webstream of this session will be posted on the research website when they become available.
Nov. 8-9, with details to come. A training session and information booth will be offered during the fall Research Fair.
Online resources
Visit the university’s Common Rule website for the latest updates on changes to Common Rule 45 CFR 46, as published in the Federal Register in January, and to learn how the university is preparing for this policy update. The executive summary and flowcharts provide an overview of how the changes may impact Nebraska researchers. Human subjects researchers are encouraged to use this resource for details on the campus’s transition process, explanations on how to comply with the changes, frequently asked questions, and additional links and information.
In June, four higher education associations collectively requested a one-year delay to the January 2018 compliance deadline. Should that happen, the university will post compliance deadline updates on the Common Rule website.
For more information, contact Sara Frizzell, director of Research Compliance Services, at sfrizzell2@unl.edu or 402-472-4491.
