Step 3: Application Review Process
Once you submit your application The Office of Research Integrity performs initial checks on your application to check required trainings, assess the application and supporting documents and review guidelines for risks to human subjects (participants).
Your application may be unlocked for revisions in IRBNet during this initial review. We do this in order to mitigate the amount of revisions needed by the IRB co-chairs. We may ask for more details, to upload missing materials, or address some issues in the application regarding participant risks.
Final Review
Determination of the level of IRB review. The IRB will determine what level of review is necessary: exempt, expedited, and full board review.
- Please note that exempt review is not exempt from the IRB review process. This simply means that this determination is for projects that are exempt from some of the stricter regulations for human subjects research. It is still subject to all basic policies, regulations, and standards for all research involving participants.
Once your initial revisions with the ORI are completed we will send your application to the IRB co-chairs for their review as well. They may have further revisions after the initial review which will be communicated to you through IRBNet.
The IRB office assigns your project an appropriate level of review depending upon the risks and benefits to the participants per 21 CFR Part 56.
This determination is given to projects that present no more than minimal risk to participants and qualifies for an exemption based on 45 CFR 46.104.
- Educational research that are considered "normal educational practice" in an "accepted educational setting". This must not adversely affect student or educators normal practices. Research conducted within the classroom must not be published or presented by students.
- Surveys, interviews, and focus groups with adults where participants identity cannot be readily ascertained.
- Observations of public behaviors where participants identity cannot be readily ascertained.
- Benign behavioral interventions with adults where participants identity cannot be readily ascertained.
- Identifiable information limited data sets.
This determination is given to projects that present no more than minimal risk to participants and for minor changes within approved projects based on 45 CFR 46.110 and HHS Expedited Review.
- Clinical studies of drugs and medical devices in which a new drug application is not required or an investigational device application is not required.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy nonpregnant adults who weigh at least 110 pounds.
- Collection of biological specimens for research purposes by noninvasive means.
- Collection of data through noninvasive procedures.
- Research involving materials that have been collected, or will be collected solely for non-research purposes (such as medical treatments or diagnosis)
- Collection of data from voice, video, digital, or image recordings.
- Research on participant characteristics or behavior that does not qualify under exempt categories.
- Continuing review of research previously approved where no subjects are put at greater risk than identified.
This list applies regardless of the age of subjects, except as notated.
This determination is given to projects that are more than minimal risk and may involve vulnerable populations. This also applies to research that does not fit into the categories of exempt or expedited research that could pose more than minimal risk. All projects that involve prisoners are required to be Full Board Reviews.
When Full Board Review is required The Office of Research Integrity will notify you of this and describe the process for board review. The Full Board meeting dates can be found at WKU IRB. If you know your project will be considered for Full Board Review please submit your application by the first of the month to have it reviewed at that months meeting.
Note that review times can be subject to change based on application volume and complexity of the application. Please ensure ample time for review for your application. To ensure quicker review times, be sure to submit your revisions in a timely manner and look for any correspondence from ORI via IRBNet and emails.
Exempt Review: 5-10 business days
Expedited Review: 5-15 business days
Full Board Review: 20-30 business days
Amendments of Existing Protocols: 5-10 business days (this heavily depends on the changes to be reviewed in the application.)
Continuing Reviews (Extension) of Existing Protocols: 5-10 business days
Renewals of Existing Protocols: 5-15 business days
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