How do I know if I am conducting research with human subjects?

Activities involving interaction with and the collection of information about living individuals are integral components of the educational practices and administrative processes of the University. Not all of these activities meet the regulatory definitions of "research" and "human subjects." As such, not all of these activities require IRB review.

Only projects meeting both definitions of "research" and "human subjects" as provided below come under the purview of the IRB. The initial determination as to whether a research project should be considered "human subjects" "research" is the responsibility of the investigator. This determination should be made in accordance with the definitions and guidance below and in consultation with the IRB as appropriate.

Research — A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
(45 CFR 46.102(d))

• In general, studies that involve data gathered solely for internal, on-going campus use (e.g., course evaluation or institutional program development), or are part of classroom projects that will not be presented outside the classroom do not need to be reviewed by the IRB. If results of these studies will be disseminated publicly in any way (e.g., conference presentation, publication), then the study is considered to constitute "research." If no dissemination is planned at the time the data is gathered, but the possibility of future dissemination exists, the researcher is advised to submit the project for IRB review and approval before initiating the research.

Human Subjects — A living individual about whom an investigator obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
(45 CFR 46.102(f))

• Research on deceased individuals is not subject to IRB review.
• Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject (e.g., telephone call, e-mail).
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., medical record).
• Identifiable information means the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

Only projects meeting both definitions (research and human subjects) come under the purview of the IRB.

Why is my research subject to review?

Through an agreement with the U.S. Department of Health and Human Services the University of Chicago assures that all research involving human subjects conducted at the University of Chicago or by University faculty, students, or staff, will be conducted in accordance with the ethical principles spelled out in the Belmont Report. This agreement assures that the University complies with all federal regulations and policies for prior review and continuing approval by an IRB of federally-funded research. The University has chosen as matter of institutional policy to extend such review to non-federally-funded research.

Additional information about the University's human subjects research protection policies and Federalwide Assurance (FWA—the agreement with DHHS and the federal Office for Human Research Protections) can be found here: http://humansubjects.uchicago.edu/.

Who will review my research?

The University has authorized the SBS IRB to review social and behavioral science and other human subjects research conducted through units other than the Biological Sciences Division/Hospitals, the School of Social Service Administration, and the Chapin Hall Center for Children. The SBS IRB is comprised of faculty researchers, administrators, and at least one non-University affiliate and one individual whose expertise is non-scientific.

How do I submit my research for review by the IRB?

The IRB submission process is completely electronic. Applications are created and submitted for review through the IRBWise website:

https://sbsirbwise.uchicago.edu:2443/sbs/loginpage.

New users can quickly and easily set up an SBS IRBWise account by sending an email with the user's name, department, University position, and CNET ID to sbsirbwise@listhost.uchicago.edu.

When do I submit my research for review by the IRB?

When submitting projects, sufficient time should be allowed for review. A schedule of the IRB Board meetings and submission deadlines are posted on the SBS IRB website. The IRB Board meets at least once monthly during the academic year and as needed at other times. For projects requiring review by the convened IRB, proposals must be submitted two weeks prior to a scheduled meeting in order to be placed on the meeting's agenda. Projects eligible for expedited review procedures are reviewed on an ongoing basis and are generally not considered by the committee at its meetings. These projects are reviewed throughout the calendar year, and the review process generally is completed within two to three weeks from the date of submission.

For additional information about the SBS IRB's review procedures, please consult the IRB Manual or contact the IRB Staff.

How will my research be reviewed?

The review of human subjects research protocols is confined solely to procedures associated with the ethical treatment of study participants. The review process focuses on such issues as minimizing risk to subjects, ensuring voluntary participation, and protecting participants' privacy and the confidentiality of information about them.

Where can I get assistance regarding IRBWise or human subjects research in general?

The SBS IRB Staff acts as liaison between the University's social and behavioral science research community and the IRB and is also able to answer questions about routing protocols to the appropriate University IRB office. If you have questions, problems, or inquiries about the policies and review practices of the SBS IRB, please call 773-834-7835 or email sbsirbwise@listhost.uchicago.edu.

To facilitate your use of IRBWise and to learn more about the issues involved in conducting human subjects research, the SBS IRB offers individualized one-hour training sessions. Please contact an IRB staff member to set up a training session for you or your department.

What happens if I do not comply with the University policy and Federal regulations regarding human subjects research?

If non-compliance is alleged, the IRB Chair will initiate an investigation. The researcher will be informed of the allegations and given ample time to respond. The IRB Chair will then review the relevant information and make a Report to the Institutional Official, including recommendations. Non-compliance can have serious consequences for both the researcher and the University: approval for the project may be terminated and the University could be placed at risk of losing Federal or other funding related to research activities. The IRB Chair is required to report cases of non-compliance directly to the appropriate Dean, with a copy to the Institutional Official who has executive responsibility for enforcement the University's FWA. If the Institutional Official determines the non-compliance to be either serious or continuing, it must be reported to OHRP and, if sponsored, to the sponsoring agency.