Regulatory Core

Review Process for Investigator-Initiated Research

Le Bonheur's formal review process for unfunded or underfunded investigator-initiated research is designed to improve the quality of the study and help researchers use resources efficiently. It is recommended that the review process be completed prior to IRB submission for applicable studies. Information about Institutional Review Board research requirements can be found in the CFRI "Regulatory Basics" presentation.

Additional resources:

Chart Review Request Process

To request a chart review, please follow the Chart Review Request Process.

Clinical Trial Registration

Investigators with PI initiated studies should register and submit Clinical Trials to This is an FDA requirement for some trials, and the International Committee of Medical Journal Editors (ICMJE) requires registration as a condition of publishing research results generated by a clinical trial.

To register, go to As part of the registration process, you will need to create a Protocol Registration and Results System (PRS) account. For Le Bonheur, put under organization – LeBonheurCH. For UT, put under organization - UTennessee

All Research Education videos are available online. Anyone interested in viewing the videos should contact Kerry Moore at for the password.