3/24/2016: External IRB Review

The Human Subject Research Office (HSRO) is sending this communication to notify you of procedural and policy changes related to the conduct of human research studies at the University of Miami. We value the feedback we have received from all stakeholders and seek to continuously improve the service we provide to facilitate the important research being conducted at UM.

External IRB Review

In an effort to ensure effective turn-around times during this transitional period at the Human Subject Research Office, effective immediately, new studies may be submitted to an applicable external commercial IRB (WIRB, Quorum, Sterling, etc.) for review. These new studies must meet the following criteria:

  • Newly being submitted for initiation at UM
  • Industry-funded and/or supported
  • Involve an FDA-regulated product (drug, device, or biologic)

Studies not meeting the above criteria will be considered for external IRB review on a case-by-case basis. For studies being submitted to an external IRB, University of Miami policies require that you complete an abbreviated eProst New Study Application for tracking purposes. To do this, please follow the directions contained within the External IRB Investigator Guide. If your industry sponsor requests to use a commercial IRB not already included on the list of external IRBs currently in the eProst application form, you must contact the HSRO for approval to use the IRB in question.

Use of an external IRB requires the execution of an IRB Authorization Agreement between UM and the external IRB. In order to facilitate these requests, please complete HRP-216 – FORM – External IRB Reliance Application and submit to the HSRO for review and approval.

Should you have any questions related to this process, please contact the HSRO at 305-243-3195 .