Social & Behavioral Sciences Institutional Review Board

The Protection of Human Subjects involved in Research

Research activities conducted by University of Chicago faculty 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.

For a more detailed discussion of which research projects must undergo IRB review, see Does My Research Need IRB Review?

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

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.

Continuing Review Requirements (Renewal of IRB Approval)

Federal regulations require an IRB to conduct substantive, meaningful continuing review of human subjects research that is within the IRB's jurisdiction. For federally funded research, continuing review of human subjects research projects is required at least annually even if no changes have occurred to the recruitment materials, research procedures, or subject population during the IRB approval period. For many studies that are minimal risk and not federally funded, the SBS IRB grants 3-year IRB approvals. The SBS IRB's 3-year approval policy is available on the IRB website.

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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.

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Important Information

Final Rule published by HHS on 1/19/17 -- Summary of Provisions

Full Committee Review Meeting Dates

Contact the SBS IRB

IRB Newsletters

Illinois Mandatory Reporting Law for Child Abuse and Neglect

University Policy on Payments to Research Participants

Data Use Agreements and Restricted Data Licenses

3-Year Approvals for non-federally-funded minimal risk research: The SBS IRB is implementing a major policy change effective on March 2, 2015 -- the SBS IRB will begin issuing 3-year IRB approvals for minimal risk research that is not federally funded. Studies that are more than minimal risk or receive federal funding will not be eligible for 3-year approvals and will continue to undergo annual IRB review after the initial IRB approval.

As of March 2, we will be issuing 3-year approvals for eligible new studies, and for eligible studies that are already approved by the IRB and are coming up for renewal of IRB approval. The policy that fully explains the criteria for 3-year approvals is at /page/sbs-irb-policies-and-procedures.

We are asking researchers to keep in mind the following points:

-- It is the principal investigator's responsibility to notify the IRB if a study's funding status changes. If the SBS IRB issues a 3-year approval for your study and you later obtain federal funding for that study, you must immediately notify the IRB (see the specific instructions in the attached policy on what to do in this situation).

--Researchers need to let the IRB know when an IRB-approved study closes (ie, is done with data collection and data analysis) by emailing us at sbs-irb@uchicago.edu, so we can close out the protocol in AURA. We want to avoid having a lot of protocols with 3-year approvals listed in AURA as active studies that are actually done with data collection and analysis.

Social & Behavioral Sciences Institutional Review Board

Social & Behavioral Sciences Institutional Review Board