Get Started: IRB Review Process
To ensure that your study goes through the IRB process as efficiently as possible, review these links before getting started:
Does My Study Need IRB Approval?
IRB approval is needed for all studies involving Human Subjects Research. Not sure if your study involves Human Subjects Research? Click here to find out how to obtain that determination.
The IRB review process for submissions has several steps:
- When you submit your new protocol, your study goes to IRB Pre-review where the IRB office will work with you to make sure your submission is correct and complete. The IRB may request revisions or missing/additional information as needed.
- Next, the IRB Coordinator will forward the submission to the Department Chair or Faculty Advisor. If the application is not complete enough to move forward, it will be returned to you for corrections and/or additions.
- Once the submission is deemed complete, it will begin the review/signature process. At this point it will take approximately 1 week (exempt reviews) to 6 weeks (expedited and full reviews) for the review to be complete.
- If your study involves other institutions such as the VA , then additional stages are required.
Remember, this 1-6 week range takes place after the first two pre-review stages are complete. Be sure to allow yourself enough time for the entire review process.
Note: Do not begin your research study until you have a final, formal approval letter from the ETSU or ETSU/VA IRB as well as other required institutional approvals (i.e., VA R&D approval if a VA study, MSHA approval if a MSHA study, etc.)
There are two types of training you must complete in order to submit studies to the IRB:
- IRB Manager Training: New protocols are submitted to the IRB electronically. Before you can submit your study, you must be trained on the IRBManager system. Click here to get started on this process.
- CITI Human Subjects Training. Anyone involved as study staff in a research study at ETSU must be up to date on their Human Subjects training. Select this option to get started on your training today.
Note: While CITI training is not required prior to submitting a study in IRBManager, a study cannot be approved until CITI training is complete. Also, we recommend that you complete your CITI training prior to starting your IRBManager submission as it covers information that must be considered when creating your study.
Things to Think About
Before submitting a study, there are several things to think about:
- What type of review will it be? Exempt, Expedited, or Full Board
- What type of consent do I need? Will I request a waiver?
- What attachments are necessary?
Those are just a few things to consider. Here are a couple links to get you started: