When the IRB receives an application that is prepared in such a way that the proposed research procedures are unclear or large components of the application are missing, reviewers will be unable to provide meaningful comments and guidance. In such cases, the application will be withdrawn in eIRB, and recommendations for additional resources and guidance will be provided to the PI. Below are some examples of scenarios in which the IRB may determine that an application is not ready for review:
- Missing or inadequately prepared essential documents, including:
- consent form/s
- questionnaire/s or focus group materials when the main component of the study is the administration of that material
- documentation needed to determine the engagement level of any off-campus study sites
- drug or device documentation
- Inconsistent or unclear description of procedures such that the reviewers are uncertain of what is being proposed
- Project described does not seem to constitute research with human subjects as written
- Recurrent errors throughout the application and attachments to the extent that a detailed review and revision of the entire application is needed Information presented in the SmartForm is not in agreement with the information provided in the protocol, ICF and other supporting documents
When an application is withdrawn in this manner, the recommendation from the IRB is to:
- Seek help from the free on-campus research support services at the SUCCESS center.
- Talk with Principal Investigator’s Mentor to receive guidance on how to provide a complete application.
- Set up a meeting with the IRB Administrator and Chair
*Please refer to the SUCCESS center website at
to request regulatory services.