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Research Compliance

How to Submit an Application

Step 1. Check If You Need IRB Review

Step 2. Read About Your Responsibilities In Research

Step 3. Plan for Your Level of Review

Step 4. Plan for your Time to Approval

Step 5. Plan for the Review Process

Step 6. Review These Tips and Tricks to Make Your Submission Easier and Faster

Step 7. Review and Complete All Necessary Trainings

Step 8. Complete an Application

Step 1. Check If You Need IRB Review

Before beginning this process, determine if your activity requires IRB review, and if yes, whether Western Washington University is the right place to submit an application.

    There are three options for making this determination:
  1. Consult the regulatory definitions described below or in 46 CFR 46 for what constitutes “research” and a “human subject.”
  2. Complete our Online Guidance Tool.
  3. Call or email a Research Compliance Officer for a consultation.

Is your project considered “research”?

The regulatory definition for “research" is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. This includes pilot studies.

Additional details about the terms “systematic investigation” and “generalizable knowledge,” along with examples, can be found in our Online Guidance Tool or in our Research Compliance Standard Operating Procedures Manual.

Quick Tips for Students:

  • Class activities: You may be learning about research methods, like how to conduct a survey, as part of a class. As long as there is no intent to ever generalize the results of your activity beyond the class, these activities are not considered “research” and do not require review by the IRB. You can choose to submit an application to the IRB for review if you would like to use this data beyond the classroom or generalize from the results. The IRB cannot give retroactive approval, so if there is any chance that you want to publish or present your data then we would recommend submitting an application.
  • CEDAR: If your data or results will be published in Western Washington University's Contributing to Education through Digital Access to Research (CEDAR) database, this is often a sign of contributing to generalizable knowledge.

Does your research involve human subjects?

The regulatory definition of a human subject is a living individual about whom an investigator conducting research either (1) obtains data through intervention or interaction with the individual OR (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

“Intervention or interaction” includes online surveys. Obtaining “private information” includes observation of public or private behavior.

Additional details about the terms in this definition, along with examples, can be found in our Online Guidance Tool or in our Research Compliance Standard Operating Procedures Manual.

Is the WWU IRB the right IRB?

Your research must be reviewed by Western Washington University it if meets the criteria for “engagement” as defined by the federal regulations:

An institution is considered engaged in a particular human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

Step 2. Read About Your Responsibilities In Research

Who is the Principal Investigator?

The Principal Investigator (PI) is responsible for the ethical conduct of the human subjects research. There is one PI per application, though you might have co-PIs that assist with the research design and implementation.

Students may be PIs under the direction and guidance of a Faculty Advisor, who is also listed on the application.

Do you need or want a PI Proxy?

We ask for one person to be the point of communication with our office. By default, that is the PI.

If you want to delegate that responsibility, so that someone else communicates with our office, you can list a “PI Proxy” on your human subjects application. When a PI Proxy is listed, we will direct communication to that person and look for correspondence from that person. The PI will remain CCed on communication.

How do I include my co-investigators?

You will not be asked to list specific co-investigators on your human subjects research application. PIs are responsible for managing their study team, including obtaining documentation of personnel training in human subjects research.

If you want co-investigators to be included in email correspondence about your application, simply CC them on any emails to our office. We use the “reply all” function when responding, which will include any person that you CC.

If your co-investigators are from another university, please list their university as a research location on the human subjects application form.

What is expected of me as a PI or Faculty Advisor?

Principal Investigators and Faculty Advisors must sign a Responsibilities Agreement when submitting an application, which outlines the expectations of your roles. There are two places to find and review these responsibilities:

  1. Page 3 of the Human Subjects Research Application Form
  2. The Human Subjects Research Application Approval Signatures E-sign Form

Please look carefully through this list of responsibilities, so that you know what is expected.

Quick Tip for Students:

We expect that you and your faculty advisor are actively working together on the research project, but the specifics of that collaboration vary significantly. Some student PIs work independently, with only general oversight from their Faculty Advisor. Other student PIs work very closely with their Faculty Advisors at every stage in the application process. We don’t know where you fall on that spectrum. We will rely on you to help us involve your Faculty Advisor in the conversation as desired, based on your unique collaboration. At a minimum, your Faculty Advisor will be CCed on email communication.

What else do I need to know?

We have some guidance documents to help you along the way with the rules and regulations around research:

- Research Compliance Standard Operating Procedures Manual
This is a large, but searchable document. If in doubt, search this document to see whether your question might be answered.

- Application Guidance Question By Question
This document contains guidance about each question on the application. If you are unsure about a particular question, this is one place to look.

- Students Conducting Research Manual
This is a general guide for students who are conducting research. It contains information about the application process and how to manage your IRB application after approval.

Step 3. Plan for Your Level of Review

There are three levels of review: Exempt, Expedited, and Full Board. Each level has specific eligibility criteria, defined by federal regulations (45 CFR 46), that are based on factors such as risk level, tasks involved, and subject population. When an application is submitted, your reviewer will assign a level of review. A majority of research projects at Western Washington University are eligible for exempt or expedited review.

It is encouraged, but not required, for you to estimate your study’s level of review before submission. There are three methods for estimating your level of review:

  1. Review the federal language, either in 45 CFR 46 or via our Research Compliance Standard Operating Procedures Manual.
  2. Complete our Online Guidance Tool.
  3. Call or email a Research Compliance Officer to discuss your study.

The level of review will determine what is needed for your application packet, how many people on staff will review your application, and the expectations for your study after approval. It is one among many factors that impact your study’s time to approval.

Step 4. Plan for your Time to Approval

Your application approval time may be shorter, longer, or the same as average approval times (6-8 business days for exempt, 8-10 business days for expedited, and 1 month for full board). Full board studies are not reviewed over intersession or the summer quarter. Exempt and expedited studies are reviewed throughout the calendar year. Please plan ahead to allow time for review.

The time to approval depends on:

  • the completeness of the application,
  • the level of review,
  • the complexity of the research,
  • the workload of the IRB,
  • the time of year, and
  • the responsiveness of the researcher to questions.

Step 5. Plan for the Review Process

Application Receipt

AApplications are received during business hours (Monday through Friday, 8 AM – 5 PM). They are placed in a queue and are reviewed in the order received. A Research Compliance Officer (RCO) screens your application. They look to see that the application is complete and clear and assign a level of review (Exempt, Expedited, or Full Board).

Application Screening

If the packet is incomplete, or there are questions for clarification, the RCO will email you with a list of questions, requests, or suggested revisions along with instructions on how to respond. This can involve responding via email or setting up a meeting with the RCO. A majority of applications involve at least one screening “back-and-forth.” There may be multiple screening back-and-forths until your application is complete and clear. We do our best to respond within 3 business days of receiving emails. This includes your initial submission and any screening responses.

Final Review and Approval

Exempt Eligible Applications: When your application is complete, the RCO will issue you an “exemption determination memo.” In some circumstances, your memo will have conditions for approval, which are steps to complete before initiating part or all of your research. When you have met the conditions in the memo, or if there are no conditions, you can start your research. Most exempt eligible applications are approved without conditions.

Expedited Eligible Applications: When your application is complete, the RCO will send your packet to a second reviewer from the Institutional Review Board (IRB). The second reviewer will look over your application materials. If the second reviewer has additional questions or suggested revisions, the RCO will work with you to respond. When the RCO and the second reviewer agree that your application is complete, the RCO will issue you an approval memo. In some circumstances, your memo will have conditions for approval, which are steps to complete before initiating part or all of your research. When you have met the conditions in the memo, or if there are no conditions, you can start your research.

Full Board Applications: When your application is complete, the RCO will send your packet to the Institutional Review Board (IRB) members. The RCO will begin scheduling an IRB meeting regarding your application. When the IRB meets, they will vote on your application. They can vote to approve without additional conditions, approve with conditions, defer voting until revisions are made, or disapprove the application. The RCO will issue you a memo with their determination.

Step 6. Review These Tips and Tricks to Make Your Submission Easier and Faster

There are several steps you can take to make your submission as fast and easy as possible:

1. Submit a complete packet

A majority of screening back-and-forths are to request accidentally missing responses or materials. Before submitting, a quick check goes a long way. Did you answer all of the required questions on the Human Subjects Application form? Did you attach all of the required materials to your submission email (recruitment documents, all study instruments, consent forms, etc)? Do you have your application approval signatures?

2. Use the consent checklist

The next most common reason for screening back-and-forths is to work on elements of consent in the consent form. Did you look through the consent checklist? Are elements 1 through 16 covered?

3. Time your submission, if possible.

We tend to be the busiest during the middle of the quarter. During busy times, the queue for review is longer. If you are able to submit your application during less busy times, the queue for review will be shorter.

4. Respond as soon as possible

The averages times to approval listed are calculated with the assumption that researchers are able to respond promptly to questions or requests. The sooner you respond, the higher your response will be in the queue, and faster we will get back to your application.

5. Consult with a Research Compliance Officer.

You can meet with a Research Compliance Officer at any stage in the process. If you would like advice on how to structure the application, that can be helpful for more complex research. If you are unsure about any of the screening comments or questions, we can help clarify.

Step 7. Review and Complete All Necessary Trainings

Training in human subjects research protections is required for the Principal Investigator, Faculty Advisor (if applicable), and any other personnel who will interact or intervene with subjects or have access to their identifiable data. This is a free online training through CITI that takes an estimated 3-6 hours. Here are instructions on how to register: How to Register for CITI Trainings Instructions.

Some types of research require additional training, depending on the funding source. Review the applicable training requirements for your research.

These training certificates are not submitted along with your application. It is the responsibility of the PI to maintain documentation of these trainings for all research personnel and ensure that trainings are up to date. Our office will conduct post-approval monitoring checks of training certifications. When requested, you should be able to promptly provide a list of past and present research personnel and documentation of their trainings.

Step 8. Complete an Application

1. Visit our Human Subjects Forms webpage to download the Human Subjects Application Form.

2. Carefully read the first few pages of the Human Subjects Application Form then complete the form.

3. Gather all of required attachments for your application submission. Reference the color-coded attachment checklist on the first few pages of the Human Subjects Application Form.

A complete application packet may include (but is not limited to):

4. Obtain the necessary approval signatures for your study.

If you are using the e-sign form: The e-sign form is only designed to obtain signatures. This form is not designed for final submissions of your application materials to RSP/the Compliance Team.

5. When your application packet is complete, email the materials to compliance@wwu.edu.

You may send the Word (.DOC or .DOCX) versions of documents. The only document that must be converted to a PDF is the Application Approval Signatures page, if you choose to obtain written approval signatures in lieu of using the e-sign form.