Any investigator intending to initiate a research study involving human subjects that requires IRB oversight must submit an initial application for review and approval. 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. The IRB process begins by submitting an initial application via eRA. For step-by-step instructions for creating and submitting this submission in eRA refer to the Initial Application Submission Guide.
The initial application submission should include, but is not limited to the following:
- Initial Application Form (only accessible via eRA)
- Copies of CITI completion reports for all key personnel named on the study
- Protocol Document using the IRB-provided template
- Informed Consent Document(s) using the IRB-provided template
- Recruitment materials (flyers, print/radio ads, social media ads, phone scripts, etc.)
- Data collection and/or assessment tools
- Any related funding applications
- Any other related study documents
Pre-Submission Checklist for Initial Applications
- Read the Investigator Manual (required for Principal Investigators; recommended for all study staff)
- Review study staff Roles and Responsibilities
- Complete CITI training (all study staff)
- Download Protocol and Consent Form templates from IRB website
If you have questions, email email@example.com or schedule time to meet with one of the IRB Coordinators.