The SU IRB is committed to working with our researchers to protect the privacy, welfare, and personal information of all human research participants. Whether you are collecting data for a class, pedagogical project, or other activity involving information from living individuals or their private records, all SU students, faculty, and staff must first consult the IRB or submit an application before initiating any aspect of a project (including recruitment).
You might never intend to publish or present your findings, but the IRB must assess whether risks to potential participants could exist in the recruitment or data collection process, regardless of what you plan to do with the information. Even pilot studies need IRB approval if they involve human participants.
Students should read our Student Researchers page, as well as the Step-by-Step Guide below. Your Faculty or Staff Adviser should be involved to provide guidance in all stages of the process.
Collaboration with Non-SU affiliates: When collaborating with non-SU researchers, you may request that the SU IRB cede oversight to their institutional IRB, depending on that institution's policies. For some programs, such as the College of Nursing, if researchers must go through a separate IRB (e.g., the Swedish/Providence IRB, etc.), the SU IRB will consider ceding oversight even when the SU affiliate is the sole investigator. When planning collaborative research, always consult with the SU IRB early in the process. You must obtain written permission/documentation before participating in any aspect of a collaborative study. Rarely, but occasionally, the SU IRB might require changes to ensure appropriate risk mitigation for participants; for this reason, start the IRB process as early as possible.
Click here for more information about ceding oversight to another institution's IRB.
CITI training helps researchers design a robust, ethical protocol by reviewing foundational principles of human participant research (e.g., informed consent, voluntary withdrawal, etc.), as well as potential risks in data collection and storage. CITI training is required of researchers working with human participants by most IRB offices within the United States.
Expedited and Full-Board submissions to the IRB require CITI training certification for all Seattle University researchers and key personnel, including faculty advisers. CITI training is recommended but not required in Exempt submissions.
Some protocols may require supplemental modules, depending on the nature of the population and research.
Note: If non-SU personnel will assist with recruitment or data collection, or if your study involves research partners/assistants for whom traditional human participant training might not be appropriate, contact the IRB. Example: In a study involving unhoused individuals, researchers might wish to provide basic oral instruction on informed consent, confidentiality, voluntary withdrawal, etc. to representatives from that population, representatives who also might help with data collection.
Closely read IRB guidance on different review categories and approximate timelines (which may alter with faculty board members' availability due to academic calendar factors, such as finals week, holidays, etc.). Then, create an outline and realistic timeframe for starting your project. Out of courtesy to all researchers, the IRB cannot rush any reviews or adjust timelines arbitrarily.
Establish a method to recruit participants, and create oral or written scripts for recruitment. For research with minors, adults with decisional impairment, incarcerated persons or those under correctional supervision, international communities, read the IRB guidance about research with special populations.
Develop all necessary materials and tools, such as consent documents, survey or interview questions, etc. Refer to the IRB consent templates and related forms.
If you are conducting online research, you will need to provide any survey URLs with your IRB submission, so the IRB may verify appropriate consent language and voluntary progression through questions.
Develop a clear, robust data security and data storage plan.
Read all IRB Application Tips to avoid delays due to incomplete or incorrect submissions.
As of 1 July 2023, use the OneAegis system to submit your proposals to the SU IRB Office. For all submissions made after 30 June 2023, first, log into SU OneAegis with your SU credentials.
The website address should look like this "https://seattleu.oneaegis.com/" and the login page will ask for your SU username and SU password before directing you to the OneAegis system. Once logged in, click "Start new xform" if you are beginning a new application. The form will ask for Project Title, PI information, and will ask you to choose what type of application you are submitting. The categories are:
Choose the category that you think your research fits into, based on the criteria and examples provided on this website, your CITI training, and -- in the case of students -- discussion with your advisor.
After you have begun the application, we suggest bookmarking the page; you may then return to finish that particular application at your convenience. When ready, click, "Submit." All subsequent processing and decisions will be made through the OneAegis system.
For students, first make sure that your advisor knows that you plan to submit an application. Note that the OneAegis system will not "recognize" your advisor when you try to list them if that advisor has never logged into the system before. The login need not be specific to an application -- your advisor simply needs to have clicked on the login page and verified their identity at some point. Once you, as the student, completes your application, the system will route your complete, submitted protocol to your faculty/staff adviser for review and sign-off before it comes to the IRB Office.
Note the required file naming convention indicated within the submission system, which will accept PDFs only (no JPGs, PNGs, RTFs, or links to shared drives).
If you need assistance with the e-submission system, contact the IRB.
Most IRB reviewers are faculty members; thus, review timeframes will be slower during final exam weeks, holidays, and official university breaks. The IRB does not review full-board submissions during the summer months.
After a submission via OneAegis, the IRB reviews the application. The IRB then makes an initial determination within OneAegis, choosing one of the following options:
If the application does not provide sufficient information to make an initial assessment, the application will be returned to the PI. It is the PI's responsibility to provide more details. If the submission is clear and complete, then the IRB will be able to make an initial assessment. If the determination is that the application either meets criteria for Exemption or meets "Not Human Participant Research" criteria, then no further review with the IRB is required.
Exempt and NHPR Studies are reviewed on a rolling basis and are processed by the IRB Director during normal SU operations. Contact the IRB with any questions about exemption criteria before submission. If an application does not meet exemption criteria, you will need to revise the application to meet exemption criteria or resubmit as an Expedited application, depending on the nature of the study.
Doctor of Nursing Practice (DNP) Submissions are considered a special category in certain respects. Timelines might vary significantly, depending on the volume of submissions and the calendar. DNP students will experience smoother processing by carefully following all guidelines and requirements outlined in their CON DNP instructions and the SU DNP guidance page
Expedited Studies, which are also reviewed on a rolling basis, are processed by IRB Director, and then sent out for further review. IRB board members then evaluate expedited submissions based on federal human participant research regulatory criteria, SU IRB policies, and best ethical practices in human participant research. After Expedited Review and IRB Office processing, you will receive either Approval or a request for revision feedback via OneAegis. Once you adequately address any revision requirements, and the protocol meets conditions for approval, the IRB office will issue a formal approval letter via OneAegis, after which you may initiate your study.
Full Board Studies must be submitted 3 weeks before the monthly IRB Board meeting (see academic-year Full Board Deadlines & Meeting Schedule), still via OneAegis. Multiple IRB members serve as primary reviewers for Expedited Studies, but all IRB members review all Full-Board protocols. During the IRB meeting, the Board considers protocols within federal review and approval criteria, SU IRB policies, and best ethical practices in human participant research. Often, the researcher (and faculty adviser, if applicable) are invited to attend a brief portion of the meeting to provide possible clarifications. You will receive the Board's feedback after the meeting. Once you have addressed any revision requirements, the IRB office will issue a formal approval letter via OneAegis. In rare cases, a protocol may require a second Full-Board review and revision process.
No research activities (including recruitment) may begin until you have received a written IRB determination of Exempt or IRB approval of an Expedited or Full-Board study.
Once the IRB approves an Expedited or Full-Board study, you (and your faculty adviser, if applicable) are responsible for a number of post-approval actions. A study categorized as Exempt does not require any subsequent approval by the IRB unless you change your study protocol.
If you have a currently open protocol that predates the 1 July 2023 roll-out of OneAegis, then you will continue to use the traditional Modification Request, Continuing Review, Close-Out Report, etc. forms that are available on the IRB website. If you submit a protocol after 30 June 2023, then Continuing Review and related post-approval monitoring will be done primarily through OneAegis.
After a study has been approved, you (and your faculty adviser, if applicable) are responsible for contacting the IRB Office for the following:
Project reclassification or conclusion