Step-by-Step Guide

At the earliest stages of planning, you should complete human participant research training. Understanding foundational principles of human participant research (e.g., informed consent, voluntary withdrawal, etc.), as well as potential risks in data collection and storage, will help you design a robust, ethical protocol.

Expedited and full-board submissions require CITI training certification for all SU researchers and key personnel, including faculty advisers. Some protocols may require supplemental modules, depending on the nature of the population and research. (While applications for exemption do not require this training, best ethical practices recommend completing it.)

• Instructions for accessing CITI human participant research training

Note:  If collaborating with non-SU personnel assisting with recruitment or data collection, or if you will have research partners or assistants for whom you believe traditional human participant training may not be appropriate, contact the IRB.  (For example, in one study involving unhoused individuals, certain representatives from that population helped with data collection, and the researchers gave these individuals basic oral instruction on informed consent, confidentiality, voluntary withdrawal, etc.)

• Read closely the 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.).
• Create an outline and realistic timeframe for starting your project. Out of courtesy to all our SU researchers, the IRB cannot "rush" any projects 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, such as consent documents (review IRB templates), survey or interview questions, etc.
• If applicable, read the IRB guidance on 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 storage plan.

• Read all IRB Application Tips to avoid delays due to incomplete or incorrect submissions.
• Choose and complete the appropriate submission form (exempt, DNP, or expedited/full board). Always use current forms from the IRB website.
• Assemble all required documents, such as recruitment scripts, permissions from external sites, consent forms or scripts, interview questions, survey URLs, human participant research training certification, etc.
• Proofread all materials for accuracy and errors to maximize clarity and ensure professional credibility as a researcher (to the IRB and to your participants).
• Obtain all necessary signatures, as applicable: PI, co-PI, faculty adviser, site mentor, etc.  The IRB does not accept typed names and will return your submission.
• Carefully note the required file naming convention indicated on the submission form. Do not send scans from printers that have no appropriate label.
• Submit as properly labeled PDFs or Word docs (no JPGs, PNGs, RTFs, or links to shared drives) to irb@seattleu.edu.
• Include appropriate message text in your submission email. (Emails with no text and only attachments often divert to the Junk/Clutter folders, where the IRB will not see them, and they may auto-delete.)

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. More details about Review Categories & Timelines.

• Exempt Studies (reviewed on a rolling basis) are processed by the IRB Administrator in approx. 6-10 business days 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 be directed to revise the application to become eligible for exemption or to submit an expedited application, depending on the nature of the study.
• Doctor of Nursing Practice Submissions (reviewed on a rolling basis) are processed by the IRB administrator in approximately 2-4 weeks. However, timelines vary widely, depending on the volume of submissions and calendar. Projects submitted between mid-November and the beginning of January could experience significant delays up to a month or more. 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 (reviewed on a rolling basis): IRB members evaluate expedited submissions based on Federal human participant research regulatory criteria, SU IRB policies, and best ethical practices in human participant research. After the IRB Office processing (1-2 weeks), you will receive revision feedback in approx. 2-3 weeks, depending on the academic calendar. Once you adequately address any revision requirements, and the protocol meets conditions for approval, the IRB office will issue a formal approval letter, after which you may initiate your study. (Average time from submission to approval is 5-8 weeks, depending on necessary revisions.)
• Full Board Studies must be submitted 3 weeks before the monthly meeting (see academic-year Full Board Deadlines & Meeting Schedule).  Multiple IRB members serve as primary reviewers, 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 typically receive the board's feedback 4-5 business days after the meeting. Once you have addressed any revision requirements, the IRB office will issue a formal approval letter. In rare cases, a protocol may require a second full-board review and revision process. (Average time from submission to approval: 6-8 weeks, depending on necessary revisions.)

Note: No research activities (including recruitment) may begin until you have received a written IRB determination.

Once the IRB approves your expedited or full-board study, you (and your faculty adviser, if applicable) are responsible for the following post-approval actions:

    Project revisions

• Modification Request -- Before implementing any change(s) in your approved protocol activities, you must submit a Modification Request and receive written IRB approval for the change(s).
• Unanticipated Problems -- If something does not go according to plan in a way that places participants at risk or causes undue concern, you must report these circumstances to the IRB as soon as possible.
• Post-Approval Monitoring (PAM) for Expedited Studies -- The IRB will check with researchers approximately a year after IRB approval to inquire as to the project status (completed, continuing, paused, etc.). The study will be closed and new approval extensions will be set accordingly.
• Continuing Review Application (CRA) for Full-Board Protocols  -- If your research will continue beyond the full-board approval expiration date, you should submit a continuing review request at least a week before your approval expires.
• NOTE: If you do not submit a CRA for your full-board protocol or respond to PAM inquiries for a expedited protocols, the IRB will administratively close the study after 60 days. Any further data collection without a new protocol submission and approval will represent noncompliance.

    Project reclassification or conclusion

• Downgrade to Exempt (DTE) -- If you have finished collecting all your data and will no longer interact with participants, you may request that your project be downgraded to exempt, thereby ending IRB oversight or reporting obligations.
• Closeout Report -- If you have not requested a DTE, then you should submit an IRB closeout report when your project is complete, so that we do not maintain open records for your protocol.

All forms are available on our Forms & Templates page.