The University of Utah SIRB team follows the guidance provided by the DHHS on the Engagement of Institutions in Human Subjects Research.

The lead PI and study team are responsible for assessing each participating site (pSite). If a site is determined to be engaged in research requiring IRB approval, and the study is using a single IRB (SIRB) model, the site must enter into a reliance agreement with the SIRB.

Separate legal entities will often have separate site "FWA numbers" and will require their own reliance agreements. Sometimes several separate legal entities work together as a "performance group". It is common for one performance group to need multiple reliance agreements.

You can also assess your pSite's readiness to be involved in a SIRB project.

Only the main study personnel have access to the main study application. If you’ve only been added as part of a site, that will be the only area of the study you have access to.

Site control locations are included on a study as an additional location where a portion of the research  takes place. They are overseen by personnel at the site and can have their own documentation and personnel. Each site control location will go through a separate approval process . Details of what’s done for the study at these locations are dictated by the main study’s application.

Study locations are similar in that they can have additional personnel added specific to the location, but they use the documentation from the main study application, and are overseen by the study location personnel.

There are different kinds of access in a site application:

• Site PI’s, Site Faculty, and Site Contact Persons all have access to view the site application.
• Site PIs and Site Contact persons have the ability to edit the site application.
• Site and Study PIs are the only ones who can submit an application.

Yes, if the main study is approved to have this consent process aspect. Check with your local HRPP to ensure your site allows for the use of short forms.

Next, check with your lead team to design this component of the consent process.

The University of Utah IRB provides an extensive Translation Library, which includes 60+ languages. These short form consent documents are not study-specific and, if the study is approved for short form use, they do not need to be attached or separately approved in the ERICA application.

No, a site continuing review will be created simultaneously with a study continuing review.

This will be determined based on the role that you have within a site. Site PI’s, Site Faculty , and Site Contact Persons all have access to view the site application, but only the Site PI and Study PI have the ability to submit a site application.

The Responsible Investigator and all Study Contacts have access to edit the site application and can assist if needed. If they are unsure of how to help/proceed, please contact us at irb@hsc.utah.edu.

“Site Bundling” is a  term used to describe the process of grouping the study application and the site applications together to move them to the next phase of the application approval process. Examples of these phases would be “Submission” and “Final Approval”.

Site bundling can be initiated at multiple steps during the approval process for Continuing Reviews, but it automatically occurs for study amendments where sites are impacted by the changes.

The only way a site may be 'bundled' on a Continuing Review is if the appropriate actions have been taken on the site application, and it is ready to move to the next step.

For example: Filling out all required fields on the site application before the study application is submitted. By 'bundling' these applications together, only one action is required to advance the approval process instead of one action per submission.

No, site amendments can be submitted and processed separately from the main study.

This is caused by an outstanding study continuing review or amendment with the site selected. Only one application can be open for any site at a time.

No, your site will only be included if the amendment affects your site directly.

Yes, a site may create their own final project report outside of the main study.

If an event or study situation meets SIRB reporting criteria, it must be submitted through the main study application within 10 working days of the PI becoming aware (Note 5 working day for VA research).

Not all events require SIRB submission; however, all events should still be documented at both the site and study level to monitor for potential continuing non-compliance.

Study teams are encouraged to use an event or unanticipated problem tracking template, with PI sign-off documenting review and determination of whether reporting criteria are met. Sites must also comply with their own local reporting policies in addition to SIRB requirements.

More information here.