Institutional Review Board (IRB)
The mission of the Southwestern University (SU) Institutional Review Board (IRB) is to evaluate SU faculty, staff, and student research proposals to ensure that human participants are treated with respect and safety and that their rights are protected, following the federal guidelines set forth in the US Department of Health and Human Services’ “Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects ”
Southwestern University holds a Federalwide Assurance (FWA) #27279, approved by the Office for Human Research Protections (OHRP). Expiration date: 08/30/2028.
THE IRB COMMITTEE
Committee Members for 2023-2024 include:
- Ed Merritt (Chair), Department of Kinesiology
- Erika Berroth, Department of Modern Languages & Literature
- Jennie Demarco, Department of Biology
- Bryan Neighbors, Department of Psychology
- Raquel Sáenz Ortiz, Department of Education
- David Gardner, external community member
- Kim Faris, Director of Institutional Research & Effectiveness
WHO MUST SUBMIT THEIR PROPOSALS?
With a few exceptions, anyone conducting academic or administrative research with human participants (including research where human tissues or cells will be collected or analyzed) must submit proposals to the IRB. For IRB purposes, research projects include not only standard faculty research but also class research projects, research abroad, student-led independent studies and capstone research, and administrative research. Examples of research methodologies include (but are not limited to) experiments, surveys, questionnaires, interviews, participant/informant observations, interventions, and program evaluations. IRB Submission Decision Tree.
WHAT ARE THE IRB DEADLINES FOR THE ACADEMIC YEAR?
The IRB committee regularly reviews proposals during the fall and spring semesters (rolling deadlines for expedited reviews; on the 1st and 15th of each month for full reviews), and does not typically review proposals after the last day of classes in the spring and prior to the first day of classes in the fall; therefore, researchers should make appropriate plans. Usually, the first committee meeting of the academic year is during the first week of the fall semester.
During the fall and spring semesters, the IRB Committee will meet to discuss proposals that require a full review. For proposals submitted by the 1st of the month, the committee will ideally meet between the 8th-10th. For proposals submitted by the 15th of the month, the committee will ideally meet between the 23rd-25th. Proposal authors will be invited - but not required - to attend full board reviews in case the committee has any questions while they discuss the proposal. Proposal authors will not be present during the committee’s vote.
***** Policy for Summer Reviews *****
The Southwestern University IRB does reviews for the following types of IRB proposals during the summer:
- New proposals requiring an exempt or expedited review.
- Proposal modifications that are essential to continue data collection during the summer (see “Proposal Modifications and Extensions Procedures” for additional information).
The IRB cannot review new proposals or proposal modifications that require a full board review during the summer.
WHAT IS MINIMAL RISK?
Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Research studies that are more than minimal risk require a full review by the IRB committee and all researchers associated with the study (including student researchers) must provide a certification of ethics training prior to proposal review.
MAJOR CATEGORIES OF IRB PROPOSALS
1. FACULTY OR STAFF RESEARCH WITH OR WITHOUT STUDENT COLLABORATORS
All faculty or staff research projects that meet the definition of human subjects research must be approved by the IRB before any recruitment or data collection can begin.
2. CLASS RESEARCH PROJECTS
If class research projects involve human subjects research and are presented outside of the classroom, including capstone and Student Works Symposium presentations, they must go through the IRB process.
If class research projects involve human subjects and expose participants to greater than minimal risk, involve vulnerable populations (prisoners, pregnant women, people under 18 years of age, or other vulnerable groups), or involve sensitive information (such as sexual activity, drug use, illegal behaviors, etc.), they must go through the IRB process.
All faculty members who assign class research projects on human subjects are expected to comply with ethical requirements even when it is determined that they are not required to submit a proposal to the IRB (minimal harm and research is not presented outside of the classroom).
3. STUDENT RESEARCH ABROAD
When Southwestern University students study abroad and conduct research on people, they are required to go through an Institutional Review Board (IRB) approval process. To make sure that the research students conduct while abroad meets the Southwestern University Institutional Review Board guidelines, please read through the IRB policy for Student Research Abroad.
4. MODIFICATIONS AND EXTENSIONS OF PREVIOUSLY-APPROVED RESEARCH (INCLUDING CLASS PROJECTS)
See Modifications and Extensions guidelines for additional information.
5. PROJECTS APPROVED BY IRBS FROM OTHER INSTITUTIONS
If any Southwestern faculty, staff or students intend to be involved as researchers on the project (i.e. participating in data analysis, study design, etc.), they must submit the IRB materials and approval from the other institution to email@example.com to be kept on file. Participating researchers will be expected to comply with all requirements of the governing IRB.
At this time, outside researchers who would like to recruit members of the Southwestern community for a research project but do not have Southwestern faculty or staff involved as researchers on the project (i.e. not participating in data analysis, study design, etc.), may not do so.
If you have questions about how to complete the form or are unsure about whether your project requires submission, contact the IRB at firstname.lastname@example.org