Step 4: Responsibilities After Approval
Your application has been approved and you may begin research. You may be required to have additional reviews in the future if you are making changes, adding personnel, or extension of your project. You will also need to keep up to date with CITI trainings for all personnel on the study. Please see below for more information on these additional reviews.
All amendments require an additional review of the approved protocol. This is done through the amendment form submitted into IRBNet under your original package.
All changes are required to be documented but here is a list of some common examples:
- Adding key personnel or students to your project
- Changing or adding surveys, questionnaires, interviews, or any participant interaction.
- Changes or additions in funding
- Changes is participant incentives
- Please note that all changes in incentives must be prior to participant recruitment.
- Changes in the way participants are being recruited or consented.
Please submit your amendment form and consent documents highlighting any changes.
Annual updates of your protocol are required if you are continuing research, including data analysis. These are often called continuing reviews for annual renewal up to 3 years of protocol. Please fill out the continuing review form and submit into IRBNet in a new package under your current protocol. Approval of your continuing review will grant you another year.
No research may occur after your protocol is expired. If your protocol has been expired for over 45 days, you will be required to submit a new application for your research.
Renewal applications are required the third year after your initial protocol approval. This should be done using the renewal application form and submitted into IRBNet in a new package under your current protocol. This is done in order to provide complete review of all changes and updates within the project.
Your renewal application is similar to the initial application. You may copy and paste your initial application into it but add and highlight all changes made over the course of the protocols lifecycle. This makes it clear to the IRB what changes have been made and approved and allows us to have a most updated version of your application on file.
These reviews take less time than an initial review.
CITI trainings should be maintained and kept up to date during the course of your research. Responsible Conduct of Research CITI Training does not expire. However, the Social/Behavioral Research Course expires every three years. Maintaining these CITI Trainings keeps you in compliance and limits the amount fo revisions needed during your protocol updates and continuing reviews.
New personnel on the study should have these trainings up to date and completed at the time of their approval by the IRB to begin research.
1. Login to IRBNet
2. Click on “My Projects” on the lefthand panel
3. Click which project you are submitting a continuing review or amendment for
4. Click “Create New Package”
a. This will be close to the bottom of the Project tab on the left side. You need to create a new package not a new project
b. The IRBNet ID should be the same number as the original project but with a -2 or -3 depending on how many packages are open in this project
5. Complete the application (continuing review, amendment, renewal) and save it on your computer
6. Press Attach New Document
7. Upload Continuing Review Form
8. In Document Type select Amendment or Continuing Review
9. Upload the following required documents:
a. Continuing Review Form, Amendment Form, Renewal Form
10. Upload any supporting documents, if applicable:
a. Email scripts
b. Recruitment flyers
c. Budgets
d. Letters of support
(All documents can be uploaded on the same screen.)
Please note that these documents are ONLY needed IF you are changing these specific documents or have additional material which was not uploaded originally.
*this is needed if you have any other person listed on the project and they will need to review and sign the package before approval*
11. Click Share this Package on the left-hand menu.
12.Select Organization:
Western Kentucky University, Bowling Green, KY
13.Search for the appropriate user(s).
14. For signature-only access, select Access Type: Read.
15. Click Save.
16. Click Sign this Package on the left-hand menu.
17. Select your title from the dropdown menu.
18. Click Sign.
19. Enter your IRBNet login credentials when prompted.
20. Click Continue to confirm the package has been signed.
21. Click Submit this Package on the left-hand menu.
22. Select Organization:
Western Kentucky University (WKU) IRB
a. Important: A COI (Conflict of Interest) option will also appear.
Ensure you submit to the IRB side, not COI, so the package is reviewed by the correct board.
23. Under Submission Type, select Amendment/Modification or Continuing Review
24. Add any comments you wish to share with the IRB.
25. Click Submit.
When the IRB requests revisions it will send you an email with the revisions requested
- Revise the documents requested
- Open your project in Designer
- Click the pencil icon on the document you need to re-upload
- Click Attach
Lock the Package
- The red unlock icon signifies this package is still unlocked
- In Designer press Mark Revisions Complete
- Then Submit
If this step is not completed the IRB will not receive notification that revisions are complete which could cause delay.
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