Do not initiate any aspect of a project that collects information from or about living individuals (except for publicly available data) until you have received prior written IRB exemption or approval. Even recruitment cannot be started until you have received this exemption or approval.
Beginning 1 July 2023, the IRB will implement its new e-system: researchers will submit all new studies via the SU OneAegis system using your SU credentials. The online system will accept PDFs only. Follow file naming conventions described in the application. For students, submitted applications will first go to your faculty/staff adviser/mentor for verification of completeness and accuracy before being routed to the IRB Office. You will be unable to submit applications missing required or documentation.
If you have a currently open Expedited or Full-Board protocol -- one that predates the roll-out of OneAegis -- you should continue to use the traditional, post-approval forms offered on this page and listed below. These include Modification Requests, Continuing Review forms, etc.
Many of the forms offered below will not be used by researchers who are currently using the SU OneAegis system. The Consent and Assent forms are still useful, however, as are the templates listed in the Appendices. We will post here when Modification Requests and Closeout Reports become available through OneAegis, but in the meantime, please continue to download the traditional forms and email them to the IRB.
NOTE: If you wish to initiate a request with the SU IRB Office to cede oversight to another institutional IRB Office, you cannot use OneAegis. Instead, follow the directions below.
SECOND NOTE: If you are new to Seattle University and have an existing project that was approved by your previous institution's IRB Office, you nonetheless still must begin a new application to the SU IRB Office via OneAegis.
For all new IRB applications, 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. Choose from the list of options provided by the system which category you think your research falls into and then follow the e-system's directions to complete the application.
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."
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.
If you wish to initiate a request with the SU IRB Office to cede oversight to another institutional IRB Office, you cannot use OneAegis. Instead, follow the directions below.
Before creating your consent documents, we recommend that you read the guidance section on the Informed Consent process.
To ensure all required informed consent elements are present, we strongly encourage researchers to use the sample templates listed below. However, you may edit the templates or submit an alternate consent form to meet the needs of your particular research study.
Choose whichever of the following templates is most appropriate to your study:
When you have an individual other than the researcher involved in data collection, you need to ensure they know their responsibilities to keep all participants' responses confidential.
You should include a version of the templates listed below with your protocol submission and then obtain a signed copy from the translator/interpreter for your protocol files.
In some cases, a professional transcription or translation firm may insist on using their own agreement templates and these should be included in your files as well.
Beginning 1 July 2023, these appendices will be merged within the e-submission system and will no longer be required as separate documentation. We plan to continue to provide these on our website, both as reference for new researchers and as a resource for researchers with active approved protocols that predate 1 July 2023.
Certain methodologies, populations, or settings require greater consideration with regard to mitigating risk. The appendices provided below solicit more specific information, which enables IRB reviewers to better assess risk to participants and offer recommendations for mitigation.
For Expedited and Full-Board studies submitted via OneAegis after 1 July 2023, you will use the e-system for any further post-approval actions.
If you have an open Expedited or Full-Board protocol (not one determined as Exempt or NHSR), you will continue to use the forms below and submit them via an email to firstname.lastname@example.org
To read more about specific post-approval requirements and to ensure you remain in compliance with SU and Federal policies, click on the links below for more information: