Information for Researchers

  1. Institutional Review Board and Office of Research Oversight
  2. Information for Researchers

To comply with federal regulations and SU policies, all SU affiliates must submit any proposal involving human participants to the Office of Research Oversight.

Beginning 1 July 2023, researchers will submit all new studies via the Seattle University OneAegis system using their SU credentials. A researcher with a currently open protocol that predates 1 July 2023 should continue to use traditional post-approval forms for Modification Requests, Continuing Review, etc.

Your proposal to the IRB will fall into one of the following review categories: Exempt, Expedited or Full Board. Here are a few details on these categories and their review timelines:

  • Certain types of low-risk research submissions may be determined by us to be “Exempt” from IRB oversight. This initial determination will be made by the Director, typically in under a week's time. Occasionally, the Director may disagree with a PI's self-designation of "Exempt" and escalate the project to Expedited -- this necessarily lengthens the review timeline.
  • Projects reviewed at the Expedited level involve some privacy or psychological and/or physical risk to human subjects participants, but to a minimal degree. Expedited submissions will be assigned to individual Board members by the Director and the subsequent peer review typically takes two weeks. You must complete CITI human subjects training for Expedited submissions.
  • Both Exempt and Expedited submissions are reviewed on a rolling basis, after submission through OneAegis.
  • When research activities pose risks to participants significantly higher than those encountered in daily life, the study will need review by the full IRB Board. You must complete CITI human subjects training before you submit a project for review at the Full-Board level. You must submit full-board studies three weeks before the monthly meeting. 

Information about Ceding Oversight

SU affiliates who collaborate with researchers at other institutions may request that the SU IRB cede oversight to another institution. This is particularly common when the PI for a project is affiliated with another institution. Sometimes, this is called a Reliance Agreement. No SU affiliate may engage in any aspect of a collaborative study until receiving written documentation from the SU IRB regarding ceding oversight. The SU IRB does not have a separate form for ceding oversight. To initiate the process, please refer to our FAQ section on Ceding Oversight and then email us.

Information for Faculty and Staff Researchers

From off-campus studies, to pedagogical research in your classroom, to advising student researchers, the IRB supports SU faculty and staff on all aspects of projects involving data collection from individuals or from their private records.

SU faculty and staff research projects tend to fall into several categories. Traditional scholarship based on research with human subjects in which a faculty/staff is the PI always requires that faculty/staff submit an application to the SU IRB office before research begins. SU faculty/staff classroom-based research projects also typically require a submission. Certain types of programmatic evaluations and quality assessments may likewise need to go through the IRB application submission process.

The federal definition of research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” If you are uncertain whether your project constitutes research with human participants, please contact us. We may decide that your project fits the "Not Human Participant Research" determination.

Many other faculty and staff projects will eventually receive an Exempt determination from the SU IRB office. Others will require Expedited or Full Board Review. Only after this determination has been made (and, in the case of Expedited and Full Board reviews, Approved), may any aspect of the project begin.

Information for Student Researchers

Students engage in human participant research activities in different ways. The three most common here at Seattle University are:

  • As part of a course, SU students often conduct minimal-risk research overseen by the faculty member teaching the course. Course projects will end up falling into one of two categories: "Not Human Participant Research" or Exempt. Because these projects are for a course, the students need to first coordinate with the faculty teaching the course before contacting the SU IRB.
  • SU students also sometimes serve as the Primary/Principal Investigator (PI) on research projects involving human participants for an Honors, Capstone, or individualized, graduate-level project. In these cases, students should submit a protocol application directly to the IRB after consulting and working closely with an SU faculty/staff adviser. These projects are most often determined to be Exempt or Expedited. If Expedited, both the student and the advisor will need to provide proof of CITI training.
  • SU DNP students must, as part of their programmatic requirements, serve as Primary/Principal Investigator (PI) on research projects and these projects typically involve human participants.

Student PIs will use the OneAegis portal for submissions. Students, please 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. Once you finish 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. 

Students conducting research for a course should consult with the faculty teaching the course before trying to submit a proposal via OneAegis, as the requirements are often different.

DNP students and advisors should consult their Canvas pages, as well as Nursing's DNP guidelines, for additional information.