Pre-Submission IRB Consultation

Review Guidance for Serving as IRB of Record document to determine whether the UTHSA IRB is likely to consider serving as the IRB of record.  If you have specific questions about whether the UTHSA IRB can serve as the IRB of record, please contact the IRB office for assistance before submitting the application.

1. Determine who should initiate submission to UTHSA IRB through the SMART IRB platform or directly to UTHSA IRB (normally the Lead PI).
2. During this time, the following resource forms will be discussed with Lead PI/Study Team:

• SMART IRB Standard Operating Procedures if utilzing the SMART IRB agreement
• Agreement Implementation Checklist and Documentation Tool (this is the preferred selections version)– This form is used to document which options institutions will implement as part of the Ceded Review. If more flexible terms are needed, use the blank version of the documentation tool.
• Single IRB Institutional Profile - A reviewing IRB POC may use this survey to obtain key local context information from relying institutions.
• Single IRB Protocol Specific Form (for each site) - This survey will aid in obtaining key information from relying site study teams to determine whether particular regulatory or institutional requirements should be communicated to the Reviewing IRB. This form is key in documenting the reliance in the SMART IRB's Reliance Online System (SIORS).
• Overall PI (and Lead Study Team) Checklist – This checklist will help the Overall PI understand and fulfill his/her responsibilities. 
• PI Checklist, Relying Institution - This checklist helps site investigators and study teams understand and fulfill their responsibilities when a study has been ceded to an external institution. This form is important for the collaboration, but does not need to be submitted to the UTHSA IRB.
• Communication Plan – This tool is key to documenting communication roles, such as submitting initial and continuing reviews, amendments, and reportable events to the Reviewing IRB; providing conflict of interest management plans to the Reviewing IRB; and providing IRB-approved documents and communicating Reviewing IRB determinations to relying site study teams and is required to be submitted to the UTHSA IRB.
• Form K-2 or similar to document Relying Site’s agreement to cede review if not utilzing the SMART IRB agreement.

Additional Resources: https://smartirb.org/resources/