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 |
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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. |
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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. |
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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:
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UUIRB Review Process & Meeting Schedule The UUIRB's review process has two steps:
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. |
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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. |
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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. |
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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. |
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