Education and Social/Behavioral Science Institutional Review Board (ED/SBS IRB) Newsletter, IRB Insider / Volume 6, Issue 2, November 2017
Some revisions to the Common Rule (aka the Federal Policy for the Protection of Human Subjects) are expected to go into effect January 19, 2018 and the UW-Madison IRBs are proactively preparing for these changes. The revised Common Rule reduces IRB and other oversight for many research studies involving human subjects that can be classified as minimal risk. To learn more about these changes please visit our revised common rule webpage and sign up for our upcoming information session:
The Department of Health and Human Services requested a delay in implementation of some of the proposed revisions to the Common Rule, but has not identified which aspects of the revised Common Rule would go into effect in 2018 and which would be delayed, if the request is approved, until 2019. The UW-Madison IRBs will begin applying those components of the revised Common Rule that will go into effect in 2018 to new studies approved on or after January 19, 2018. IRB staff will work closely with study teams to identify the best implementation strategy for each initial review submission.In the past CoCs were issued by NIH upon request. Usually CoCs would be required when study teams planned to collect identifiable information for research purposes that could put individual subjects at risk for criminal or civil liability or be damaging to the subjects’ financial standing, employability, or educational advancement. As of October 1, 2017, NIH will automatically issue CoCs as a condition of award when a study, exempt or non-exempt, involves the collection or use of identifiable, sensitive information. Note that NIH defines “identifiable, sensitive information” as cases when subjects can be identified, biospecimens are collected or used and either are identifiable or have a risk of being identifiable, the research involves the generation of individual level human genomic data, or the research involves any other information that might identify a person. In addition, the NIH is retroactively covering ongoing research funded by NIH as of December 13, 2016.When a CoC was specifically applied for, the NIH required specific language to be included in consent documents which identified the limits of the CoC’s protections. The UW IRBs will work with study teams to include appropriate language in consent forms for new or already approved studies that fall under this policy change. This may require study teams to revise consent documents in some cases.NOTE: The UW IRBs can still require CoCs for studies that are not NIH-funded. In these cases, the institution will need to apply for the CoC to cover that study rather than a CoC being automatically issued.
- Tuesday, December 5th: 2:00 p.m. - 3:00 p.m., Lathrop Hall, Room B137, register here.
NIH Single IRB Review Policy
NIH issued a policy requiring single IRB review for multi-site research funded by NIH. The effective date for this policy is January 25, 2018. This policy will apply 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
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 remaining trainings for Fall 2017:
- IRB 103: How to Avoid Delays in the IRB Approval Process on November 9 at 2 p.m. in Lathrop Hall, Room B137
- *Recently Added!* ARROW Redesign on November 29 at 10 am in the Education Building, Room 159. In December 2017 the ARROW interface will be redesigned to provide a cleaner, more modern look. While the look and feel will be the biggest change, there will be some new features and minor changes in navigation and location of features. This session will give ARROW users an idea of what ARROW will look like come December and highlight some of the new features and changes that can be expected with the redesign.
- IRB 200: Consent Considerations on December 6 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.
facet of our curriculum is tailored outreach sessions for classes,
groups, or departments. IRB staff would be happy to come to a
department meeting, research methods class, or hold a brown bag session
to help faculty, staff, students, and other researchers learn more about
the IRB process. We can also address specific topics such as
international research, research on campus, research with minors,
technology-based research, etc. To schedule an outreach event, please
visit the Outreach Sessions
page of our website.
Education Needs Assessment Survey
This survey is intended to gauge the training needs of our campus research community. As the Human Research Protection Program works to expand educational opportunities for its human subjects researchers, your input will help us to prioritize the creation of these new opportunities. You can take the survey here
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!