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.
- Departmental Approval Form
- Over Age Study Participants for Research Study Form
- Investigator Initiated Trials Contract and Budgeting Checklist
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 ClinicalTrials.gov. 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 https://clinicaltrials.gov/ct2/manage-recs/how-register. 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