How to Create a SMART IRB Account | Texas Tech Health El Paso

How to Create a SMART IRB Account to Submit a Request for Reliance (adapted from SMART IRB)

If you are an investigator at a Participating Institution who would like to submit a request for reliance using the SMART IRB Online Reliance System, complete the "Request Investigator Access" form and follow the instructions. It is not unusual for an investigator to delegate the responsibility for completing reliance requests to another member of the research team, such as a study coordinator. In this scenario, the study coordinator or another member of the research team should also complete the "Request Investigator Access" form.

Once the form has been submitted, your request will be forwarded to the Reliance Point of Contact (POC) for your institution, who must authorize your access to the system. This process may take up to five business days. Once you have been authorized, you will receive an email inviting you to register for an account in the Online Reliance System.

How do I submit my documents to the external IRB for review? (adapted from SMART IRB)

You will need to find out the arrangements in place for submitting to and communicating with the designated Reviewing IRB.

In some cases, a lead study team, coordinating center, or sponsor will submit documents to the IRB and provide you with documentation of that IRB’s approval for your site.
Some institutions do not allow sponsors to submit applications to the IRB on the behalf of the study team.
In other cases, the study team is directly responsible for submitting documents to Reviewing IRB.

How do I know when I can start the research at my site if an external IRB is reviewing the study? (adapted from SMART IRB)

Obtaining IRB approval is one of often many approvals or sign-offs that study teams must have in place to activate a study. The same institutional requirements must be met for study activation when using an external IRB. Examples include reviews and approvals by other institutional committees (e.g., biosafety, radiation safety, pharmacy, conflict of interest, billing compliance) and executing any clinical trials agreements.

You will need to ensure you have documentation that:

your site has ceded review to the external IRB; and
the external IRB approval for the study covers your site. If the external IRB has approved the study before your site is ready to join, your site will need to be specifically reviewed and approved as a new site, which is usually accomplished via an amendment to the existing study. Activities involving human subjects at your site cannot occur until the external IRB specifically approves your site’s participation in the research and you have obtained all required institutional sign-offs and/or approvals.

“This information was obtained from Relying on an External IRB: FAQs for Research Teams as part of SMART IRB, which is funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number 3UL1TR002541-01S1.”