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Single IRB (SIRB) Services at the University of Utah

 

We provide Reliance Consultation services to help investigators initiate a SIRB model for their multisite studies. 

To facilitate this process, we communicate directly with participating site investigators, data coordinating centers, and representatives of the sites' Human Research Protection Program (HRPP).

We recognize that some institutions and sites will not have a full human research protection program. In these cases we expect at least one individual at the institution/site to help with the Human Research Protection (HRP) review. 

 

 

  
RELIANCE CONSULTATION REQUEST
   Get started by submitting a Reliance Consultation Request

 

 
Our services
 
How you can prepare as an Investigator 

Reliance Consultation Meeting

This meeting is the first step in setting up a SIRB process at the UU. Even if you aren't sure about your funding or only want to get a better feel for what the UUIRB can offer, this meeting can get your started.  

You will be contacted to set up a meeting by phone or in-person. Each meeting is led by an IRB Manager experienced in SIRB processes. 

Note that this meeting should include at least one investigator on the study, as well as any key study personnel (or data coordinating center staff) involved in the regulatory process.

During this meeting, we will help you determine if UU SIRB services are a good fit and provide you with guidance on your roles and responsibilities when using the SIRB model.  You will also receive written instructions for how to move your study through the SIRB process at the UU. 

Grant Language for Single IRB

The UUIRB provides grant language describing our expertise and ability to perform SIRB review for your study. 

This language is only provided for studies that have been preliminarily accepted for UU SIRB services through a Reliance Consultation Meeting.  

  • Participate in a Reliance Consultation Meeting.

Single IRB Fees & Budgeting

The UUIRB charges for SIRB services and can provide you with a signed quote that can be used in a budget proposal.  If funds are awarded to your study and SIRB services commence, you will be billed at the time services are provided. 

Fee quotes are only provided for studies that have been preliminarily accepted for UU SIRB services through a Reliance Consultation Meeting.  

  • Participate in a Reliance Consultation Meeting.
  • In addition to the draft proposal & list of potential sites, provide the potential funding period.

Reliance Invitation Packet

The IRB Managers will work with the lead investigator to officially invite institutions to rely on the UUIRB for SIRB services.  This invitation is timed appropriately for each study, but is only sent after

  • Participating site investigators have at least preliminarily agreed to collaborate on the study
  • The protocol is ready to submit to the UUIRB for review

The reliance invitation packet is sent via email to each participating site investigator and an HRP representative at their institution.  While the IRB Managers will send initial reminders to help follow up on the invitation, it is the responsibility of the participating site investigator to ensure the institution completes all elements outlined in the reliance invitation packet.  

The reliance invitation packet includes instructions for the HRP representative, including

  • Executing an IRB reliance agreement
  • Documenting a site's reliance decision for the study
  • Providing information about the institution, the community, and HRP review components relevant to the study
  • Finalize the protocol.
  • Prepare the email contact information for all participating site investigators.
  • Provide contact information for HRP representatives when requested.
  • Follow-up with participating site investigators to ensure completion of requirements at each site.

Reliance Agreement Negotiation

The UUIRB prefers to utilize the SMART IRB Master Common Reciprocal IRB Authorization Agreement for reliance purposes. However, there may be some cases where a different reliance agreement will be negotiated.  The IRB Managers will work with the HRP representatives at participating sites to ensure the appropriate agreements are in place.  

Note that the University of Utah does not require agreements to include reciprocal indemnification provisions, but we will use the Letter of Indeminfication to accompany the SMART IRB Agreement when necessary for the participating site.  

  • Be available to help answer questions about the project and follow up with participating site investigators. 

Documenting Reliance Decisions, Institutional Profiles, & HRP Reviews

The UUIRB tries to be flexible with this documentation and accepts it from a number of different sources, including

At the UUIRB, all of this documentation ends up linked to the IRB submission in the ERICA system. 

The UUIRB requires positive confirmation of receipt of the reliance decision and the institutional profile before a participating site will receive SIRB approval.

The UUIRB does not require the HRP reviews to be reported unless there is a concern or management plan identified by the HRP. The UUIRB will require amended materials if the study is not compliant at a given site. HRPs are under no obligation to allow the study to be conducted at their site, even if SIRB approval is granted for the site.  

  • Instruct participating investigators to initiate their HRP reviews.  Investigators must work closely with their HRP representatives to complete the HRP review.  Every site has different processes for performing this review, so submit to the HRP according to their policy.  Provide the HRP with the information they request.   
  • Instruct participating investigators to follow-up with the HRP representative on submission of the reliance decision and the institutional profile. 
  • You have the option to gain an account for accessing IREx Online.  Contact the IREx Administrator for details. 

 

 

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.

 
OUR SERVICES
 HOW YOU CAN PREPARE AS AN INVESTIGATOR 

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's 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. 

 

 

We provide ongoing review services to ensure that research can be updated and re-approved in a timely manner. 

We provide considerate review of reportable problems and events to ensure the protection of participants and the integrity of the research. Additionally, we provide mechanisms for compliance monitoring throughout the course of the study.  

 

The content on this page is coming soon! In the meantime, please contact the UUIRB if you have questions related to ongoing review. 

 

OUR SERVICES
 HOW YOU CAN PREPARE AS AN INVESTIGATOR 

Amendment Reviews

The IRB requires amendments to describe any modifications to an approved study, including reasons for the change, whether the information will increase or decrease the risk of harm to participant(s), and whether the consent form requires updating.

Amendments may be submitted for one or multiple sites, as applicable. If the study is utilizing the ERICA site-control model, participating site investigators can submit site-specific amendments. The UU IRB may need to consider applicable site-specific details before approving an amendment.

Continuing Reviews

The IRB requires renewal applications in order to review the progress for all participating sites and determine if a study may continue. This application should include information about current enrollment, ongoing enrollment, adverse events, withdrawals, study progress, and any amendments/changes. Continuing Review applications should be submitted eight weeks prior to the study expiration date.

No new forms or documents will be reviewed or approved without an amendment application. An Amendment may be submitted and reviewed in conjunction with a Continuing Review application.

If the study is utilizing the ERICA site-control model, participating site investigators can submit their site-specific continuing review information independently. This site-specific information may be included with the main study continuing review application for consideration together.

If a participating site fails to provide the needed continuing review information to be considered with the main study review, their site may “expire” while the rest of the study receives review and approval. The IRB will then review the site-specific continuing review application separately, once it has been submitted.

  • Review the guidance on Submitting a Continuing Review in ERICA

  • Determine if any amendments need to be submitted with the Continuing Review application.

  • Gather continuing review information from each participating site (i.e., enrollment, current progress, any possible issues that have arisen, etc.)

  • If applicable, review the instructions and features for the Site-Control Model

Report Form Reviews for Problems & Events

A report form application should be submitted in ERICA any time a reportable problem or event occurs at any of the sites for which the UU IRB serves as the IRB of record. Types of issues may include unanticipated problems or events, deviations, breaches of confidentiality, etc. In the report form, affected site(s) should be identified.

Reportable events must be submitted to the IRB promptly, within 10 days from the time the investigator learns of the information (5 days for research involving the VA). Late reports may be reviewed for additional non-compliance.

Once submitted, the report may be reviewed administratively or by the full board to determine if it meets the criteria for an Unanticipated Problem or Serious and/or Continuing Non-Compliance. The IRB will issue a notification in ERICA describing its determination and outline any necessary corrective and preventative actions.

It is the responsibility of participating site study teams to determine if their HRPP has local reporting requirements in addition to reporting to the SIRB when an event/problem occurs at their site. The UU IRB may need to work with a participating site’s HRPP to determine the best course of action to address the reported issue, including notification of applicable entities once a determination has been made (e.g., OHRP, FDA).

  • Review guidance on Report Forms, including Unanticipated problems or events and Deviations to determine if the event is considered “reportable”

  • Submit Report Forms only from the main study workspace, not from site-controlled applications.

  • Only attach documents to Report Form applications that do not require approval; documents needing approval should be submitted as part of an Amendment.

Investigator Self-Assessments

A lead site or participating site study team may use the UU IRB’s self-assessment tools to perform internal monitoring to ensure research is being conducted properly.

Routine and For-Cause Auditing

The UU IRB has the authority to conduct routine and for-cause auditing for any participating site which it serves as the SIRB. The participating site’s institution also maintains the ability to conduct its own routine and for-cause auditing, even if they are relying on UU SIRB. An audit may be conducted at any time, with or without prior notice to the study team. If the UU IRB deems an audit necessary, we will work together with the site’s institution to determine who will carry out these duties. This may be delegated to UU IRB staff, participating site institution, or an independent auditor.

  • Use the Self-Assessment worksheet(s) to determine areas for study improvement prior to an audit

  • If reportable issues are identified during an audit— regardless of which institution conducted the audit — they must be submitted via a Report Form in ERICA.

Final Project Reports for Study Closure

After a study is finished at all sites, the Responsible PI submits a Final Project Report to provide the UU IRB with the final progress of the study, including:

  • Total number of participants
  • Amendments since last approval
  • Problems and participant withdrawal, as applicable
  • Study results, if available
  • Sponsor/accounting information

Final Project Reports are submitted using the Continuing Review application in ERICA. You must indicate the study is ready to close in order for the application to take you to the Final Project Report. When prompted, answer “yes” to indicate a Final Project Report is being submitted and complete the remaining pages of the application.

If individual sites are requesting site closure, submit a Continuing Review application in advance of expiration and indicate which site(s) is closing.

  • Review the criteria for when and how to submit a Final Project Report

  • Gather final progress information from each participating site to include in the Final Project Report application.
 

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.  Studies benefit from ERICA's centralized documentation, communication, and review features. 

Stay in the loop and manage the status of your study and the participating sites more effectively in ERICA. 

 
OUR SERVICES
 HOW YOU CAN PREPARE AS AN INVESTIGATOR 

ERICA Access for All Study Teams & Guests

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

Guest access to studies is also available for study monitors, external auditors, and HRP representatives.

Site-Control Model

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. 

  • Study Site Information sheet coming soon!
  • Instructions for creating a multisite consent model with the Study Site Information sheet coming soon!
  Our goal is to ensure that you understand the nuances of the SIRB Model.  Whether your study has 2 sites or 20, interventions or observations, a biomedical edge or a social/behavioral bend -- we want you to feel prepared. And we have education options to get you there.  
 
OUR SERVICES

Online Education Modules

Our SIRB Learning Modules are available to anyone with access to the internet.

TO UNIVERSITY OF UTAH STAFF AND FACULTY: Watching the videos on this website DOES NOT fulfill the SIRB training requirement for the University of Utah.  You are required to complete the training via RATS Online if you wish to receive credit for the SIRB training.  For full instructions on accessing the acceptable training module, please click here and use the SIRB tab.  

Live Presentations & Education Sessions

The UUIRB can provide live presentations and education sessions specific to the SIRB Model for your group, both in-person or via webinar. These presentations and sessions are based on the online SIRB Learning Modules, but will be catered to the needs of your group. 

Contact the UUIRB for more information about scheduling a session. Costs of travel for live presentations are the responsibility of the requestor. Webinars are free of charge.  

Study-Specific Consulting

If your study has special considerations that warrant one-on-one consulting in order to establish your regulatory processes, the UUIRB can provide these services.  Consulting is provided for a fee.  

 

Last Updated: 5/4/20