Institutional Review Board
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: 09/05/23.
THE IRB COMMITTEE
Committee Members for 2018-2019 include:
- Maria Lowe (Co-Chair), Department of Sociology & Anthropology
- Abby Dings, Department of Modern Languages & Literature
- Katie Grooms, Department of Economics & Business
- Ed Merritt, Department of Kinesiology
- Marilee Parsons, external community member
- Carin Perilloux, Department of Psychology
- Natasha Williams (Co-Chair), Director of Institutional Research and Effectiveness
WHO MUST SUBMIT THEIR PROPOSALS?
With a few exceptions (see pdf below ), 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, 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.
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 matriculation convocation 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.
ETHICS TRAINING REQUIREMENT
The IRB requires certification of ethics training for all Principal Investigator(s) prior to proposal review, as well as for all IRB members. Protecting Human Research Participants (PHRP) offers an online training program that meets its education requirements for grant recipients and provides important information for anyone involved in human research. The cost is $39.99 per learner and the program takes about 2-3 hours and can be accessed here . A certificate of completion (PDF or screenshot) for this PHRP program or a similar certification program (e.g., CITI) dated within the past three years must be submitted to firstname.lastname@example.org and kept on file.
If the proposal is deemed to be more than “minimal risk” then all researchers associated with the study (including student researchers) must provide a certification of ethics training prior to proposal review.
“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.”
Faculty and staff members who go through the ethics training themselves or who require their students go through the training will be responsible for contacting their department chairs to use their program budgets to cover the training costs ($39.99 per person).
SUMMER REVIEWS OF MODIFICATION PROPOSALS
*****Policy for Summer Reviews of Modification Proposals*****
Approved: April 2019
The Southwestern University IRB does not review new proposals during the summer (after the last day of classes in the spring semester and before matriculation convocation in the fall semester). However, the IRB will review modifications to previously approved proposals that allow Principal Investigators (PIs) and/or their students to continue conducting research during the summer months. These modification proposals must meet the following requirements:
- Only modifications that are essential to continue data collection during the summer may be submitted.
- Only modifications that do not require a full board review may be submitted.
Summer modification proposals must follow the guidelines stipulated in the “Proposal Modifications and Extensions Procedures” form on the IRB website.
- If a modification becomes necessary due to an adverse event, go to the “Incident Report” form and submit it to the IRB. Stop your research immediately and notify the IRB on whether or not you can continue with your study. The IRB will then notify you if you are permitted to modify or must not continue your research.
Note: summer reviews of modification proposals may take several weeks to complete so PIs should plan accordingly.
SUBMISSION OF RESEARCH PROPOSAL FORM
- The Principal Investigator (PI) or faculty advisor should submit research proposals.
- PIs must be Southwestern University faculty or staff members.
- Proposals must be submitted as a single attached file (only Microsoft Word or Google Doc forms will be accepted. Do not submit PDF files) to email@example.com .
- For student projects, the faculty supervisor must read, if necessary edit, and approve the proposal prior to its submission.
- Proposals must be officially submitted by a faculty or staff member.
- Proposals should be submitted no later than two weeks before the proposed start date.
NOTIFICATION OF DECISIONS ON PROPOSALS
The IRB will email the PI a letter describing the results of the review, including reasons for any requested modifications or for denying approval of the project. Researchers may not begin data collection until approval is received.
MAJOR CATEGORIES OF IRB PROPOSALS
FACULTY OR STAFF RESEARCH WITH OR WITHOUT STUDENT COLLABORATORS
- All faculty or staff research projects that meet the definition of human subjects research according to the IRB decision tree must be approved by the IRB before any recruitment or data collection can begin.
CLASS RESEARCH PROJECTS
Class research projects do NOT need to be submitted to the IRB if the research activity is designed for the purpose of learning research methods, if the research exposes participants to no greater than minimal risk, if the proposed participants do not include vulnerable populations (prisoners, pregnant women, people under 18 years of age, or other vulnerable groups), if the project does not involve sensitive information (such as sexual activity, drug use, illegal behaviors, etc.) AND if the results and data will NOT be disseminated in any way outside of the classroom. Please note that Capstone and Student Works Symposium presentations are considered to be outside of the classroom and therefore do not meet the criteria for class research projects. In order to protect the rights of participants and ensure ethical conduct by all researchers, faculty members who assign class research projects are expected to review students’ research plans prior to participant recruitment and data collection, as well as to provide ongoing supervision and guidance. All faculty members who assign class research projects are expected to comply with the ethics training requirement below, even if they do not need to submit a research proposal.
For reference, here are two examples of class research project proposals submitted to the IRB:
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.
- IRB policy Student Research Abroad (Google doc)
MODIFICATIONS AND EXTENSIONS OF PREVIOUSLY-APPROVED RESEARCH (INCLUDING CLASS PROJECTS)
PROJECTS APPROVED BY IRBS FROM OTHER INSTITUTIONS
Regarding projects that have been approved by IRBs from other institutions, the following policies should be followed:
- 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 can submit the irb materials and approval from the other institution to firstname.lastname@example.org and the IRB chair(s) will determine if the materials are sufficient for Southwestern approval or if a Southwestern IRB proposal is needed.
- 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. The Southwestern IRB will be revisiting this policy shortly.
- If members of the Southwestern community wish to distribute an invitation to participate in an anonymous online survey by an outside researcher, they should click on the invitation page of the survey. If the consent page includes a statement that indicates IRB approval from another institution, the SU members may forward the invitation to potential participants. If the consent page does not include a statement indicating IRB approval and the SU members are still interested in forwarding the invitation, they should request IRB approval documentation from the researcher, and upon receipt, they can distribute the invitation. If none is provided, the invitation cannot be distributed to Southwestern community members.
If you have questions about how to complete the form or are unsure about whether your project requires submission, contact the IRB at email@example.com.
FORMS AND INFORMATION
- Research proposal form (Google doc)
- Sample recruitment statement (PDF)
- Sample consent form for adults (Google doc)
- IRB policy Student Research Abroad (Google doc)
- Sample consent statement for adults (for online questionnaires ) (Google doc)
- Sample parental consent form (for parents of research participants under the age of 18) (Google doc)
- Sample assent form (for research participants under the age of 18 who are capable of reading and understanding the form (Google doc)
- Sample offsite permission forms: