This announcement is in regards to the IRB policy regarding sponsor-investigators.

A sponsor-investigator is someone who both initiates and actually conducts a clinical investigation. According to IRB policy, sponsor-investigators must provide documentation of an audit performed by a CRO or an ad-hoc qualified auditor before the initiation of the study to verify the sponsor-investigator meets the sponsor function as described by the federal regulations.

The IRB has created Sponsor-Investigator Policies and Procedures templates for investigational drug/biologic and device studies. These templates will assist sponsor-investigators in providing documentation that they will fulfill all of the additional federal requirements to act as a sponsor. This will help to facilitate the required pre-approval audit.

These templates can be accessed on the IRB HIPAA Forms web page, or by clicking the links below:

• Sponsor-Investigator Policies and Procedures Templates – Devices
• Sponsor-Investigator Policies and Procedures Template – Drugs and Biologics

If you would like more information about the IRB policy for sponsor-investigators, please see the document Sponsor-Investigator Guidelines and Responsibilities on the IRB website, or call the IRB office at 801-581-3655.