Step-by-Step Submission Guidance
Preparing your project for submission
This will guide you in understanding the entire process, from the proposal to the approval.
Proposal, Design, and Research Training
Planning and Proposing
When planning your study, consult with your department regarding the logistics, personnel, data security measures, and funding (if applicable) for the potential study. If you are a student, work closely with your faculty advisor throughout the submission process as they will serve as the principal investigator on the project and will be the IRB’s primary point of contact regarding the study.
Design and Logistics
It’s important to create a timeline and/or framework for the study’s process. Most funding agencies and federal grants have very strict deadlines. Especially if you are seeking external funding, it is important to understand when approval from the HRPP/IRB will be required, especially if funding is contingent upon IRB review and approval. Please allow our office time to appropriately review your project if approval is required before the funder will make an award. Ideally, you should submit the project at least one month before the deadline given by your funding agency.
The Collaborative Institutional Training Initiative (CITI) has become a national standard in regards to preparing researchers with the proper ethical, logistical, and regulatory training for research specific purposes. WSU maintains a subscription with CITI that allows WSU faculty, students, staff, and affiliates to complete trainings as necessary, free of charge. We have created a CITI guidance page that will assist you in your setup and understanding of the training site. (Please note: training is required for all personnel involved in the study, including any non-WSU personnel.)
Data Security Requirements
A common risk to participants in most research is “informational risk,” or risk associated with the data collected from the participants. Proper data protection measures will need to be clearly outlined in your materials, no matter the level of risk or sensitivity associated with that data. We recommend discussing security and storage options with your IT department and/or Area Technology Officer (ATO). WSU’s Executive Policy #8 specifies certain security requirements, responsibilities, and data classifications for WSU researchers. See our Data Security Guidance page for more information.
The Process for the Protocol
1. Submission of Materials
Complete your submission at least one month in advance of the anticipated study start date. Projects that require Full-Board review should be submitted at least two months ahead of time. Understanding that timelines fluctuate based on reviewer availability and workflow, we recommend you submit your protocol as soon as you are able, as we review protocols in the order in which they are received.
Our office will need all of the materials used in the study. Some examples include the following:
- Recruitment materials, which consist of any invitation to participate in the study. Flyers, emails, person-to-person solicitation scripts, social media posts, newspaper ads, etc.
- Data Collection materials, such as survey, interview, and/or focus group questions, cognitive tests, lab visit protocols, etc.
- Consent/Assent/Parental Permission forms as needed. Please visit our Consent Form Guidance page for specific guidance on what is needed. There are templates available on our website.
- Any Addenda required for the study: The notes throughout the applications will tell you to fill out the appropriate Addenda as it becomes necessary. Examples: Addendum 2 is required for research involving children, Addendum 9 is required for research with Biospecimens.
If any materials are missing/incomplete or personnel need CITI training, our office will send a request to you regarding what is needed. The protocol will not be sent for review until all materials are received.
2. Sending the Project for Review
The compiled materials are then sent to the reviewers. Depending on the category (Exempt, Expedited, or Full Board), the initial review will be completed in about 10-12 business days. Full Board time will vary depending on the date of the meeting and when the materials were submitted; this can range from 10-20 days for the initial review.
3. Reviewing the Project
The review determines the risk level, ensures ethical principles are upheld, and confirms overall compliance with federal regulations and university policies. Reviewers are assigned to the project based on expertise and will conduct a thorough review.
4. Sending the Reviewers’ Comments to the researchers
The reviewers’ comments are compiled and sent to the researchers to revise the materials. This can be one of several exchanges, depending on the revisions required by the reviewers. Most researchers will receive at least one set of comments per protocol.
5. Revisions from the researchers
The comments will specify the changes throughout the appropriate materials (For example: “Section 2 – please clarify …”). The materials are then revised by the researchers and resubmitted for review.
6. Re-review of the Revisions
After the revised materials are received, the protocol undergoes a “Re-review” to ensure that all revisions have been made. If there are any revisions that have not been addressed, or if updates to our re-review of the protocol indicate it necessary, there will be another set of comments sent. The researchers will then have to complete the remaining revisions and submit the materials once again. Each exchange of Revision and Re-review can take about 3-5 business days. Once all revisions have been made, the approval process may begin.
The approval process consists of ensuring that all compliance, ethical concerns, and risk level determination have been fully resolved. An approval email is sent to the PI with pertinent information regarding the project, such as expiration dates (if applicable) and various responsibilities for the research team. Exempt projects receive a “Certification of Exemption” as opposed to a formal approval; the project is certified as Exempt from the rest of the regulations under 45 CFR 46. The approval/certification process can take 3-5 business days.