Education and Social/Behavioral Science Institutional Review Board (ED/SBS IRB) Newsletter, IRB Insider / Volume 6, Issue 3, February 2018
Revised Common Rule Delayed
On January 17, 2018, the Office for Human Research Protections confirmed that implementation of the revised Common Rule would be delayed until July 19, 2018 with the possibility of a further delay in implementation. Although this delay means that the UW-Madison cannot apply most of the provisions within the revised Common Rule to federally funded research (or FDA-regulated studies), the IRBs plan to implement most of the provisions within the revised Common Rule for studies that are not FDA-regulated or have never been federally funded, including:
- Applying the expanded human subjects exemption categories
- Excusing additional studies from ongoing continuing review
Implementation will begin immediately after ARROW is updated to accommodate campus policy changes. ARROW is scheduled to be updated on February 17, 2018. More information can be found on our revised Common Rule web page webpage.
Improved Ceded Review Process
Also included in the ARROW update in February will be a revised application and review process for studies ceded to an external IRB. A primary reason for this change is to reduce administrative burden for researchers by streamlining the review process for ceded studies. Highlights include:
- Streamlined application form
- Determination letters from the IRB regarding ceded review decisions
- After studies have been ceded, ability to update cede review applications to add new funding source or study team members
If you have questions about these changes, please contact the ED/SBS IRB Office.
Human Subjects Training for Non-UW-Madison Personnel
After the ARROW update mentioned above, non-UW-Madison personnel, for whom UW-Madison is serving as the IRB of Record for, will no longer have to take UW-Madison's CITI human subjects training IF personnel have completed/will complete comparable human subjects research training elsewhere. If you have questions, please contact the ED/SBS IRB Office.
NIH Single IRB Review Policy
As a reminder, NIH issued a policy requiring single IRB review for multi-site research funded by NIH. The effective date for this policy was January 25, 2018. This policy applies only to studies where the same research protocol is conducted at all study sites. Multi-site studies currently ongoing will not need to comply with this policy until a competing renewal application is submitted. Guidance from NIH regarding key questions such as costs for single IRB review and what information about single IRB review needs to be included in grant applications and proposals is pending. Researchers are encouraged to contact the ED/SBS IRB Office with any questions regarding IRB oversight for collaborative and multi-site projects.
Training and Outreach Sessions
The ED/SBS IRB office offers an outreach/training curriculum throughout the year. We hold various training sessions tailored to a particular topic. The following are the trainings for Spring 2018:
- International Research & Summer Projects on February 7th at 10 a.m. in Lathrop Hall, Room B137
- Considerations for Qualitative Research, Research with Minors, and Research involving Technology on March 6th at 2 p.m. in Lathrop Hall, Room B137
- I Have IRB Approval - Now What? on April 5th at 10 a.m. in Lathrop Hall, Room B137
For more information about these trainings and to register, visit the IRB Training Sessions page of our website.
New Guidance Documents
The The ED/SBS IRB Office has a number of new guidance documents available for study teams to use:Have questions? The ED/SBS IRB Staff are here to help!
Whether you have questions about a specific protocol, have general questions, or need help getting started, there are many ways to contact the ED/SBS IRB office.
- For questions regarding a specific protocol, contact the assigned Staff Reviewer. Instructions for identifying the Staff Reviewer are located here.
- Drop-in hours are every Wednesday from 2:00-3:00 p.m. and Thursday from 10:00-11:00 a.m. The IRB staff are located on the 3rd floor of Lathrop Hall (take the west elevator or stairs).
- IRB staff have 12-month appointments and are available for meetings/consults year-round. Individual appointments can be scheduled throughout the week. Contact an IRB staff member to schedule an appointment. Contact information is available here.
- For questions about ARROW, email email@example.com.
- To schedule an Outreach Session for your class, department, or group to learn more about the IRB, visit the Outreach Sessions page of our website.
- The ED/SBS IRB Office KnowledgeBase is a great resource for researchers and includes FAQs, guidance documents, information for new researchers, and much more!