All MSHS Sites Allowed to Use Commercial IRBs

In July, the Program for the Protection of Human Subjects (PPHS) announced that all sites within the Mount Sinai Health System can use commercial IRBs in accordance with the Icahn School of Medicine at Mount Sinai’s policy.

All requests to use a commercial IRB must be sent to IRB@mssm.edu using HRP-229A.  The PPHS office must approve any request to submit an application to the commercial IRB.  While the official IRB review will then be conducted by the external IRB, all other institutional requirements must be met. These are including but not limited to Investigational Drug Service review, Radiation Safety Committee review, submission to the Grants and Contracts Office, Conflict of Interest disclosure and management, and fulfillment of education requirements.  Requests will be evaluated to ensure these institutional requirements have been met before a study team will be granted permission to move forward with their application.

There is a one-time administrative set up fee of $575 for industry sponsored research permitted to use a commercial IRB for the official IRB review of the study.

The 229A form is available on the Forms and Documents Kiosk on the PPHS website.

For additional information, please review the Use of Commercial IRBs under Guidance and Policies.

After reviewing the 229A form and Commercial IRB guidance and policies, if you have questions about the policy and if your study might qualify, please contact Liz Carroll at liz.carroll@mssm.edu or 212-824-8225.