Getting Started

Putting Your Proposal Together

Putting a sound research proposal together can be a complicated, but rewarding experience. Research proposal structures may vary depending on the funding agency involved. Please be sure to follow the requirements specific to each funding agency. For locally funded or "unfunded" projects, the following template may be used along with the appropriate BHIRB submission documentation.

Research Proposal Template (Microsoft word)

Submission to the IRB

Every research study must have IRB approval before implementation. Submission to the BHIRB is required for all internally funded projects and some federally funded projects. The Austin multi-instutional IRB (AMIRB) can also be used for industry funded studies. To assist with the IRB submission, please contact the Office of Research Administration at 512-324-7991.

The maximum approval period for any approved project is one year. This means that every approved study, must have an annual renewal request or it will be considered terminated and can longer proceed. Please submit all renewals approximately 2 months in advance of the expiration date to avoid study interruptions.

IMPORTANT NOTICE:

The Seton Family of Hospitals requires that all investigators and research staff engaged in human subject research complete the online training program "Collaborative Institutional Training Initiative (CITI)"

The approval of any research protocol application will  be contingent upon the fulfillment of this requirement.

Directions for completing CITI training can be found here.

Clinical Research Steering Committe (CRSC)

The CRSC must approve all research projects being conducted at Seton facilities prior to implementation. This is in addition to IRB approval. The role of the CRSC is to ensure alignment of research projects with the mission and resources of the institution. Approval by the CRSC does not constitute IRB approval. Therefore, approval by both entities is necessary before any study can begin. The CRSC submission process can begin in parallel to the IRB submission process.

All study-related procedures or services conducted in Seton facilities must have prior approval before study implementation. A Services and Procedures Request Form must be completed before the Seton Clinical Research Steering Committee can evaluate the study.

Investigators must ensure that a Patient Load Form is completed for each participant who will also be receiving clinical care or clinical services at Seton facilities at the time of admission or enrollment (whichever comes first). An online version of this form can be found on the Seton SharePoint site.

Patient Load Form (pdf)
Patient Load Form (word)