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sirb initial review

We are an AAHRPP-accredited IRB that provides high-quality review for new studies from a wide array of specialties and disciplines. We have expertise to review studies that include any of the vulnerable populations described in the Common Rule, as well as many others. 

Our SIRB reviews follow all regulations and policies outlined by the UUIRB SOPs. This includes studies with oversight from DHHS, FDA, HIPAA, VA, DOD, and more.

We utilize a SIRB model that approves the lead site first, so that participating sites can be added and approved expeditiously when each site is ready.

Get started by submitting a reliance consultation request form

  • Tell us a little about your study.

  • We will contact you to set up a time to talk.

  • We'll ask you about your project, what SIRB services you need, and make sure you know what to do next.

OUR SERVICES

HOW YOU CAN PREPARE

ERICA Online System

ERICA is an online submission and review system used by the UUIRB.  It allows for not only enhanced review efficiency, but improved quality and compliance.  

Access to the ERICA system is available for study personnel at participating sites, including those that are external to the University of Utah.

 

Site-Control Model for the IRB Application

Studies with multiple sites have the option to active the Site-Control Model on the IRB application.  This model allows the site's information to be managed semi-independently from the main IRB application.

Participating site investigators and personnel can have convenient access to the information specific to their site.  Additionally, participating site investigators and personnel can have the ability to edit and submit their site's information, allowing them to help with the submission workload for their site. 

 

Confirming Site-Specific Details with the Criteria for IRB Approval

It is important for the UUIRB to consider all of the site-specific details before issuing IRB approval. Because the we connect the site-specific information directly to the IRB submission, we can easily apply the site details to our review. 

The site-specific details include the following, which are requested as part of the Reliance Consultation phase:

  • Information about the institution, the community, and HRP review components relevant to the study.
 
  • Describe any site-specific differences in methods or procedures in the IRB application.  

  • Update the UUIRB if institutional policies or relevant state laws change, so that these can be applied appropriately to the IRB application.  

  • Update the UUIRB if the HRP review at a participating site identifies concerns. 

UUIRB Review Process & Meeting Schedule

The UUIRB's review process has two steps:

  1. Pre-review by a qualified IRB staff member who ensures that the application is complete, consistent, and preliminarily meets regulatory criteria for approval
  2. Review by the convened IRB or an expedited reviewer who make the final decision about approving the study, using the Criteria for IRB Approval and applicable regulations. 

While pre-review takes time up-front, it helps to ensure that applications successfully and efficiently receive approval by the convened IRB or an expedited reviewer.  

The UUIRB has a convened meeting at least once per week. Expedited reviews occur everyday. Studies are assigned for convened or expedited review once all pre-review conditions are met. 

 

Site-Specific Consent Document Attachments

The goal for consent documents is to keep them as similar as possible across participating sites.  This makes it easier for the UUIRB to review, which in turn makes our review faster.  

The UUIRB provides a Study Site Information sheet that is used in conjunction with the study's consent document. This allows the study to keep one version of the primary consent document, while allowing sites to customize some language that is specific to them.  

Negotiating consent language can be tricky.  Let us help you make it easier.  

 
  • Study Site Information sheet coming soon!

  • Instructions for creating a multisite consent model with the Study Site Information sheet coming soon!

Translated Short Forms for Enrolling Non-English Speakers at Any Site

The UUIRB uses a Short Form that can be used at any location without changing the text, requiring re-translation.  

The UUIRB Short Forms are available in many different languages, free of charge. Additionally, if you need a language we do not presently have, we will translate it for you, free of charge.  

 

Pre-IND/IDE audits for Investigator-Initiated Drug & Device Trials

When an investigator holds an IND or IDE from the FDA, they become a Sponsor-Investigator.  This comes with many additional responsibilities from the FDA. 

The Pre-IND/IDE audit is conducted before you start the study, to ensure you have all the pieces in place to conduct a compliant study and meet the requirements of the FDA.  

The UUIRB charges a small fee for the Pre-IND/IDE audit. 

 

 

Last Updated: 9/16/20