Education and Social/Behavioral Science Institutional Review Board (ED/SBS IRB) Newsletter, IRB Insider / Volume 7, Issue 3, February 2019
Revised Common Rule NOW IN EFFECT
After several delays to the implementation of the revised Common Rule, the updated regulations went into effect on January 21, 2019. In preparation for the revised Common Rule, campus policy was revised to allow the IRBs to implement most of the provisions within the revised Common Rule for studies that are not FDA-regulated or were not federally funded. As of January 21, 2019 we can extend these policies to federally supported research that ARE NOT FDA-regulated. ARROW was updated to reflect some of the new provisions that went into effect with the revised Common Rule. Information about how these changes may affect your research and other implementation details are being maintained and updated on our website. We strongly encourage researchers to review this information and contact the ED/SBS IRB Office with any questions.
Single IRB (sIRB) Mandate and New sIRB Application
Per the revised Common Rule, sIRB review will be required for all non-exempt federally supported multi-site studies as of January 19, 2020. The NIH sIRB policy went into effect in January of 2018. To account for the sIRB mandate, ARROW has been updated to add a new sIRB application. In order to use the sIRB application, the following must hold true:
- Involve three or more external sites for which UW-Madison will serve as the reviewing IRB;
- Qualify for expedited or convened (full) IRB review; AND
- Have a separate, standalone protocol that will be uploaded in the application.
Further information about the sIRB application and process can be found here. If you have questions about any of these changes, please contact our office.
Training and Outreach Sessions
The ED/SBS IRB office offers workshops throughout the year. The following are the upcoming workshops for Spring 2019:
- "Considerations for Qualitative Research, Research with Minors, and Research involving Technology" on March 7 @ 2-3pm
This session will focus on additional considerations for performing qualitative research, research with minors, research involving technology and other unique research areas.
- "I Have IRB Approval - Now What?" on April 16 @ 10-11am
Interaction with the IRB does not end after obtaining initial approval for your project. This session explores the complete life-cycle of a human subjects research project after IRB approval, including: Changes, Continuing Review, Reportable Events, Study Completion, Data Storage, and Potential Audits
Would your class, department, or group be interested in learning more about the IRB?
Our office can plan an outreach session tailored to your needs! An IRB staff member would be happy to come to a department meeting, research methods class, or hold a brown bag session to help faculty, students, and other researchers learn more about the process. We can also address specific topics such as international research, research on campus, qualitative research, research with minors, research involving social media or other new technologies, and more. To schedule an outreach event, please contact a member of the IRB Staff.
REMINDER: Plan ahead for International and Summer Research Projects
Planning on doing international or summer research, but couldn't make it to our IRB Workshop? Come talk to a member of the IRB Staff as soon as possible about your project to ensure you are prepared and have enough time to get it approved before traveling! We have drop-in hours twice a week (see below) or you can contact us to make an appointment outside of drop-ins.
REMINDER: Human Subjects Training for UW-Madison Personnel
For researchers who have submitted applications to the ED/SBS IRB, we have required all study team members to take the the UW Social and Behavioral CITI training. However, we will now accept Biomedical or VA training in lieu of Social and Behavioral training. That being said, if any study team members have not completed any of these trainings and the application they are listed on will be submitted to the ED/SBS IRB, we prefer those study team members take the Social and Behavioral Course.
REMINDER: Changes to NetID and Training Requirements for External Personnel
As announced this fall, the IRBs no longer require external personnel to obtain netIDs and to be listed be listed on the study team member pages of the IRB application. This change was made to reduce administrative burden on researchers and IRB staff alike. A few reminders and resources regarding this change:
- While netIDs are no longer required for external personnel for the purposes of being listed in the IRB application, the ED/SBS office will still process netID requests when a netID may be needed for other purposes (e.g., completion of HIPAA training, access to ARROW for UW Health personnel who may not otherwise have a netID).
- External personnel do not need to obtain a netID to complete human subjects research or Good Clinical Practice (GCP) training. See Training Options for External Personnel for more information on these other options.
- In rare cases, external personnel may also need a netID to comply with UW-Madison conflict of interest policies.
If you have questions about when external personnel may need a netID or how to list them in the IRB application, please contact email@example.com.
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 firstname.lastname@example.org.
- To schedule an Outreach Session for your class, department, or group to learn more about the IRB, visit the IRB Workshops & Outreach 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!