Initial Submission Requirements for New Research (Exempt and Non-Exempt)
A principal investigator (PI) intending to initiate a research study involving human subjects that requires review by the IRB or IRB Office (i.e., non-exempt and exempt research) must complete and submit an Initial Review Form via Cayuse Human Ethics. Research staff or students who are not the study PI, can initiate the submission and complete the form. However, the IRB requires that the PI approve the submission in Cayuse prior to it being allowed to be routed for further review in the system (i.e., departmental, college, or affiliated hospital review).
The IRB Office does not immediately “receive” the submission after the PI clicks the “Submit” button, as several ancillary reviews may be required in the route depending on the study. These reviews may take days or weeks, delaying when IRB Office receives the submission to initiate IRB review. Therefore, investigators are advised to submit as soon as possible if the grant or other deadlines require IRB approval/exemption by a certain date.
No aspect of the study, including testing performed solely to determine eligibility for the study (i.e., pre-screening), may begin until the IRB has notified the study team of approval via an e-mail notification.
The initial submission should include, but is not limited to the following:
- Initial Review Form (only accessible via Cayuse Human Ethics)
- Human Research Scientific Merit & Feasibility Attestation Form (WSU Campus Expedited & Full Board studies only)
- Local Protocol (Created by PI even when sponsor protocol exists. Specialized templates are available.)
- Sponsor Protocol, when applicable
- Informed Consent Document(s) (Specialized templates are available.)
- Recruitment materials (flyers, print/radio ads, social media ads, phone scripts, etc.)
- Data collection and/or assessment tools
- Any other related study documents
If you have questions, email firstname.lastname@example.org to schedule time to discuss your research project with one of the IRB Staff.
How to Submit Electronic IRB Submissions
Wright State University investigators are required to use the Cayuse Human Ethics module to submit applications to the Wright State IRB. All new human subject research studies must be submitted using the Initial Application Form. All forms within the HE module are “smart” forms that add/remove questions based on your responses. Therefore, it is important that you answer every available question to avoid submitting an incomplete form. The initial application form is also utilized by the IRB to make non-human subject and/or non-research determinations, as well as process external reliance registrations, delayed onset determinations, and emergency research reports.
To facilitate your use of the system, we have posted guidance documents below.
How do I submit an IRB Application in Cayuse?
Additional resources are available on the IRB SharePoint Site:
- IRB Workshop Series Dates, Slides & Recordings
- Reviewer Checklists & Worksheets
- IRB Metrics