August 30, 2017
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, 9-10:30 a.m., Jackie Gaughan Multicultural Center, Unity Room. Register here.
- Oct. 20, 2-3:30 p.m., Nebraska East Union, Arbor Suite. Register here. A live webstream will be available. Details will be posted on research.unl.edu 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.
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 UNL is preparing for this policy update. The executive summary and flowcharts provide an overview of how the changes may impact UNL 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, UNL will post compliance deadline updates on the Common Rule website.
Research Compliance Services and the Institutional Review Board began Common Rule transition plans in spring 2017. Key milestones and ongoing activities include:
- Meeting with department chairs, faculty and staff in 13 areas to gain perspective on how regulatory changes will impact university researchers.
- Participating in a statewide IRB working group that includes IRB administrators from UNL, University of Nebraska Medical Center, University of Nebraska at Kearney and Creighton University. The working group’s aim is to strengthen collaboration and communication among the institutions and establish similar interpretations of new regulatory criteria.
- Joining SMART IRB, an online reliance system that includes more than 200 institutions. SMART IRB will assist UNL in successfully complying with National Institutes of Health requirements for single IRB review, along with additional Common Rule regulations slated for 2020 that require a single IRB for multisite research projects.
- Meeting biweekly with an IRB subcommittee, the institutional official and Bolero Information Systems to identify policies, guidance and timelines for implementation.
- Identifying changes to NUgrant, including a flowchart for the overall review process, a new project application that will become available Dec. 4, and functions for two sets of IRB processes that will be used as projects transition to the 2018 requirements. For more information about NUgrant, view the collaboration section of the Common Rule website and attend a training session.
For more information, contact Sara Frizzell, director of Research Compliance Services, at 402-472-4491.