Human Subject Forms and Policies
Think of the IRB application like any other form you have had to fill out
Think of other forms you have had to fill out, like a job application, your college application, or maybe a loan for a car.
You make make sure you have all of your information together so that you are ready to fill out the form.
How to Prepare
- Complete your CITI training: Double check if you have any co-investigators that they are up-to-date as you will need their CITI certifications too
- Prepare your supplemental documents: Recruitment, consent, the questions you will be asking participants
- Review the instructions carefully on the IRB application: Do not cut and paste information from proposals, please answer all questions in less than 6 sentences
How much time will it take to prepare?
- Completing your CITI course will be about 8 to 12 hours
- Preparation of IRB consent forms/information letters and recruitment documents about 2 hours
- Preparation of IRB application about 1 hour
- Other supplemental documents, like site permissions (schools, businesses, etc.), make take up to several weeks depending on the site. Please be prepared!
What can you expect from the IRB?
- You will be notified of receipt of your submission within 3 business days. If you do not hear, please send a reminder email.
- Your application will be pre-reviewed, and you will be notified if there are any missing materials within 4 business days.
- Your application will be returned to you with 7 business days with comments and/or approval from the IRB analysts/members.
- It’s always much quicker on your end to prepare a good submission rather than going back and forth with the IRB.
- Follow the directions on the application if forms are returned to you. IRB's are responsible for record keeping as per the federal regulations.
Preparing an IRB Application
This is not an exhaustive list, as there are many forms that can be required in the IRB process. The information below will, however, help get you started.
Please review all of the information starting with the video.
Relevant Policies and Procedures
The U.S. Department of Health and Human Services (HHS) issues and enforces rules pertaining to the protection of human subjects in research. All regulations issued by federal agencies under the statutory authority established by Congress are published in the Code of Federal Regulations (CFR). Regulations pertaining to the protection of humans subjects can be found in Title 45 Part 46 (45 CFR 46) and is divided into four subparts: A, B, C, and D.
Western Washington University’s policies, procedures and standards related to human subjects research: