Welcome to the Social and Behavioral Sciences Institutional Review Board (SBS IRB) at the University of Chicago.
News (01/22/2019): Revised Common Rule Requirements Effective 01/21/19
Most changes are designed to reduce burden on investigators and take advantage of the new flexibilities offered whenever possible. In the coming weeks and months you may notice some revised application questions, new/revised guidance, and new templates offered. Please contact the SBS IRB office (firstname.lastname@example.org) with any questions.
Some changes include:
- New and expanded exempt categories: some sensitive, identifiable research (e.g., interviews, surveys, etc.) as well as some research involving benign behavioral interventions can now qualify for exempt review or limited IRB review
- Removal of continuing review requirements for almost all research that qualifies for expedited IRB review
- Informed consent is required to begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research, and presented in a way that facilitates comprehension. For most SBS research with consent forms less than four pages, no separate summary section will be necessary—longer forms may now require a summary.
New elements of informed consent must be included (when applicable)
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to other investigators for future research use without additional informed consent
- Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject
- For research involving biospecimens: whether the research will involve whole genome sequencing, and whether specimens may be used for commercial profit (and whether the subject will or will not share in this commercial profit)
- New requirements for federally-funded clinical trials
News (09/07/2018): The NIH course will no longer be available after September 26, 2018. Please complete the course and/or print your certificate by this date. As of September 27, 2018, NIH will no longer provide access to the course or certificate. Click here to go to the NIH course page.
News (08/28/2018): Effective 01/01/2019, Exceptions to SBS Human Subjects Research Training Requirements Will No Longer Be Granted. Please click here for more information.
News (08/17/2018): Policy Updates and Continuing Reviews to be Eliminated for Most Minimal Risk Research. The SBS IRB Policies and Procedures Manual has been updated in order to begin taking advantage of the Three Burden-Reducing Provisions available to federally funded research, and to begin phasing in additional flexibilities for non-federally funded research. Look for more information (as well as updates to guidance, webpages, templates, AURA, etc.) in the coming weeks.
The Protection of Human Subjects involved in Research
Research activities conducted by University of Chicago faculty, staff, and students that involve the use of human volunteers or analysis of identifiable human subjects data must be reviewed and approved by an Institutional Review Board (IRB) if the research is designed to develop or contribute to generalizable knowledge. Generalizable knowledge refers to the intent of the research to add information to your field of study or to obtain and apply results to other settings beyond the subject population or beyond a classroom assignment.
Human subjects research activities conducted as part of a course requirement do not require IRB review if the purpose of the assignment is to learn research methodology rather than to develop or contribute to generalizable knowledge. If you are in doubt as to whether your project needs IRB review, please contact the SBS IRB and we will be happy to discuss it with you.
The SBS IRB office provides ethical and regulatory educational sessions for classrooms, student groups or research centers upon request. We also welcome individual appointments in our offices or, if needed, in other offices on campus. Email addresses and phone numbers for the SBS IRB are listed at https://sbsirb.uchicago.edu/page/contact-sbs-irb
IRB Application Review Process:
IRB approval is required before human subjects research can begin (including recruitment activities). Studies which qualify for approval under expedited review or exempt status are reviewed by the IRB Chair or a designee. Protocols determined to require review by the full IRB committee will be scheduled for the next scheduled IRB meeting. See The IRB Submission and Review Process for a detailed discussion of the submission and review process.
Human Subjects Protection Training Requirements:
Prior to submitting an IRB Application or adding new personnel to the research team, the SBS-IRB requires researchers to complete an ethical and regulatory training course in the conduct of human subjects research. For more information on human subjects training requirements, see the guidance at Human Subjects Protection Training Requirement
Using AURA-IRB online system for IRB Applications:
The online comprehensive system for IRB applications is called AURA-IRB (Automated University Research Administration). Visit: http://aura.uchicago.edu
For answers to Frequently Asked Questions on how to use the AURA software to submit applications to the IRB, please see /sites/sbsirb.uchicago.edu/files/uploads/AURA%20IRB%20FAQ%20UPDATED%2011.11.16.pdf
SBS IRB Listserv
If you would like to receive email updates from the SBS IRB with news about AURA IRB, new and revised IRB policies and guidance documents, and other SBS IRB news that affects researchers, you can subscribe to the SBS IRB listserv by going to https://lists.uchicago.edu/web/subscribe/sbs-irb and entering your email address.
Latest News and Announcements
Continuing Review Requirements (Renewal of IRB Approval)
(Update 08/17/2018) Starting August 20, 2018, continuing review requirements will begin to be eliminated on a case-by-case basis for many new and existing, minimal risk studies. Investigators on existing studies will be notified if their study is transitioned via an email in AURA, or via their approval letter if the project is approved on or after 08/20/2018. If not notified, the expiration date listed in AURA applies, and a continuing review is still required.
Guidance on when to submit amendments versus new project applications
New project or modification? That is the question. Whether ‘tis nobler to change an existing study in AURA or ‘tis better to start fresh? If you engage in research long enough, at some point you face this quandary. While there is no absolute rule to follow, here are a few questions that can help guide your decision.