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 RSP Gateway. 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 RSP Gateway 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.
PIs and study team members must also understand that 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 approved the initial application in writing via an emailed approval letter.
The initial submission should include, but is not limited to the following:
- Initial Review Form (only accessible via RSP Gateway)
- Project Specific Disclosure Form (Version 2.0)
- Local Protocol (Created by PI even when sponsor protocol exists. Specialized templates are available for content guidance.)
- Sponsor Protocol, when applicable
- Informed Consent Document(s)
- 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 with one of the IRB Staff.
How do I submit an IRB Application in RSP Gateway?
For step-by-step instructions for creating and submitting this submission refer to the Investigator Initial Submission Guidance (DOCX).
Frequently Used Forms & Templates:
- Required Project Specific Disclosure Form v2.0 (DOCX)
- Social, Behavioral, and Educational Informed Consent Template (DOCX)
- Biomedical Informed Consent and Authorization Template (DOCX)