FAQs

Click the plus sign (+) to expand the sections and read our frequently asked questions. Have other questions? Email us at admin@irbexchange.org!

What is IREx?

IREx is a freely available web-based IT platform that supports single IRB (sIRB) documentation and coordination on multisite studies.

IREx is used by sIRBs and lead study teams to document cede decisions from relying sites, capture local considerations, and document sIRB approvals for the lifetime of a study. 

Why is IREx needed?

Single IRB review requires collaboration between institutional human research protection programs (HRPPs) and IRBs, as well as lead study teams and participating sites. IREx provides a centralized space for the documentation and communication required for sIRB review and helps standardize the single IRB process.

Is IREx the same as SMART IRB?

No, but they are complementary platforms. The SMART IRB agreement can be used to outline the roles and responsibilities of those implementing the sIRB process, and the IREx platform can be used to operationalize the terms of the SMART IRB agreement, ensuring all parties comply and provide the necessary documentation.

Who maintains IREx?

The IREx support team and developers are at Vanderbilt University Medical Center based in Nashville, TN.

How long has the IREx platform been available?

IREx was launched in late 2016. However, IREx has been an evolving IT platform supporting Single IRB review since 2012. The platform was originally called IRBshare and was funded by NCRR (now called NCATs) and later evolved into IRBchoice with funding from NHLBI.

What does IREx stand for?

IREx stands for the “IRB Reliance Exchange”

How can my institution join IREx?

IREx is available to any institution with an FWA.

Anyone can request access for an Institution, but the human research protections administrator or IRB director/manager must initiate an institution’s access by completing this form. Check here to see if your institution is already a member of IREx.

Click here to view the IREx Terms of Use.

Who can join IREx for my institution/ site if we do not have an IRB? 

If your institution does not have an IRB, the person that signed for your FWA with OHRP or their designee can join. Sometimes this person is called a Human Research Protections Administrator or Manager.

My institution is an IREx member. How do I get access?

Please contact your institution’s liaisons (found here) to get access to IREx.

If you are a coordinator or an investigator needing access to a specific study, your site’s other investigators or coordinators with access to the study can add you to the study. If no other study team members have access to IREx, the Lead Study Team/Coordinator (“IREx Study Manager”) can grant access to new coordinators or PIs as personnel changes occur. Here is a quick guide for how to add other study staff to a study.

How do I update the IRB points of contacts in IREx?

Liaisons at your institution can add or ‘deactivate’ IREx access for individuals within the HRPP or IRB. You do not have to contact IREx when you make these edits. From the IREx homepage in the Resources section, you can use “Find other users” to edit existing user access or you can use “Add HRPP Staff / Members” to add new access.

I am a Study Manager and do not have access to IREx or to the study yet. What should I do?

Please contact your site’s sIRB liaison if you have questions about when you will get access to the study.

The sIRB Liaison grants Study Manager (SM) access to studies in IREx. Access may be granted at different times by different sIRBs, depending on their sIRB workflow. Some sIRBs grant SM access before a study is approved so the SM can begin listing the participating sites. Other sIRBs wait to provide access to the SM until the study has sIRB approval to ensure sites do not begin their local reviews before the protocol and consents have initial IRB approval.

I am a study investigator or coordinator and do not have access to IREx or to the study yet. What should I do?

The Lead Study Team/Coordinator (“IREx Study Manager”) will grant you access to IREx when they notify you the study is in IREx. Typically, Study Managers wait until after the Lead Site Initial Approval is uploaded to IREx before they grant access to relying site study teams. If you think you should have access but do not yet, contact the Study Manager for the study.

The IREx Study Manager can grant access to new study team members or PIs as personnel changes occur.

If a member of your study team already has access to the study they will be able to give you access. Here is a quick guide for how to add other study staff to a study.

What reliance agreements does IREx support?

IREx supports the SMART IRB Agreement v1 and v2 and one-off reliance agreements, such as an IRB Authorization Agreement (IAA), provided by the Reviewing IRB – in IREx this is called “Other Reliance Agreement” (ORA).

Additionally, the Reviewing IRB can require and track the acceptance of indemnification of relying institutions in IREx, if it is not included in the reliance agreement.

Can multiple reliance agreements be offered on a study?

Yes! The Reviewing IRB can offer the SMART IRB Agreement versions 1 and 2, as well as Other Reliance Agreements.

Additionally, the Reviewing IRB can require and track the acceptance of indemnification of Relying Institutions in IREx if it is not included in the reliance agreement.

Can sites that have signed SMART IRB use an ORA to rely on a Reviewing IRB?

Yes, if the SMART IRB Agreement is not a reliance agreement offered by the Reviewing IRB on a study, then a site in SMART IRB can execute an Other Reliance Agreement (ORA) with the SIRB for that study. However, if the SMART IRB Agreement and an ORA are offered on a study, sites in SMART IRB will default to that agreement.

Can a Reviewing IRB’s institutional reliance agreement be broad – applying to multiple studies – or are they study-specific agreements?

IREx allows the SIRB to track broad agreements that can be executed once with a site and apply to multiple studies, such as all studies that are part of a research network, as well as study-specific agreements that only support reliance on a single study.

Can indemnification terms (e.g., letters of indemnification (LOIs)) be broad – applying to multiple studies – or is it study-specific?

IREx allows the SIRB to track broad indemnification that can be executed once with a site and apply to multiple studies, as well as study-specific indemnification that only applies to a single study.

As a relying site, how do I know which agreements are offered/ required for my study?

Relying Site HRPPs can view the agreements they are expected to execute for a study on the “Complete Agreements” step in their IREx checklist.

Relying Site Study Teams can check with the Study Manager to see what agreement(s) their institution needs to sign onto if they see their reliance agreement is not already complete on the Status Summary.

Relying Institution’s agreement status is viewable on the Status Summary Tab. Note: Institutions signed on to SMART IRB are updated by IREx and study-specific agreements added by the Reviewing IRB are also updated and tracked by them. 

A site has joined SMART IRB, why isn’t the SMART IRB status updated in IREx?

A site’s SMART IRB Agreement status is updated in IREx after SMART IRB has published the site on their Participating Institutions Page. If you have joined SMART IRB and do not see this reflected in IREx, feel free to check in with us at admin@IRBExchange.org

Who updates the status of institutional reliance and indemnification agreements in IREx?

The IREx Admin team updates SMART IRB sites. If you do not see your site’s SMART agreement status accurately reflected in IREx reach out to the admin@irbexchange.org.

The Reviewing IRB logs which sites have executed their Other Reliance Agreement and indemnification

How do I indicate if a site has signed a reliance agreement or indemnification?

If you are the Reviewing IRB, you can indicate that a site has signed an Other Reliance Agreement or indemnification through the “Manage Agreements” button on your Status Summary tab, or from the homepage under “Agreements.”

How can I check if a site has signed an agreement?

A Relying Institution’s agreement status is viewable on the Status Summary Tab if listed as part of a study. Note: Institutions signed on to SMART IRB are updated by IREx and study-specific agreements added by the Reviewing IRB are updated and tracked by the Reviewing IRB. 

If a site is not yet listed on a study, use the Agreement Checker under Resources on the homepage after logging into IREx. Select the potential Reviewing IRB and add sites to check if the site has signed on to any of the agreements required by the Reviewing IRB.

As the Reviewing IRB, how do I indicate what agreements are needed to rely on my institution for a study?

After creating the study, the Reviewing IRB indicates what reliance agreement(s) can be used by relying sites in the IREx Study Setup. This is also where the Reviewing IRB indicates whether separate terms or a letter of indemnification is required.

On a study, can I require indemnification from some sites, but not others?

Yes. During the IREx Setup for the study, the Reviewing IRB indicates whether it requires indemnification from any site on the study. If a site(s) doesn’t have to fulfill the indemnification requirements (e.g., because it is a state institution), a Reviewing IRB liaison indicates the site is allowed to rely without the indemnification. This action occurs on the study in the Agreement Manager, which is accessed from the Status Summary tab. The site’s indemnification status will then appear as ‘not required’ on the Status Summary Tab.

Does the Reviewing IRB have to offer SMART IRB as a reliance agreement on a study in IREx?

No. The Reviewing IRB can choose to only offer an institutional reliance agreement, such as an IAA, on a given study. The reliance agreements offered are at the full discretion of the Reviewing IRB.

Can Relying Institutions indicate reliance while the agreements are under review by an institution’s legal team?

No. Relying Institutions must have executed the required agreements for a study before they are able to indicate reliance. However, Relying Institutions may document their local reviews (local considerations) in IREx before all the agreements have been executed, if desired.

How does a Relying Institution indicate an agreement has been executed?

Relying Institutions do not log executed agreements in IREx, as it must be verified by the Reviewing IRB requiring the agreement.

Relying Institutions should email or fax (per the instructions from the Reviewing IRB) all executed agreements to the Reviewing IRB Liaison or contact for the study. The Reviewing IRB Liaison can then indicate the agreement was fully executed in IREx.

How will a Relying Institution know if the Reviewing IRB marked an agreement as completed or executed in IREx?

Relying Institutions will receive an email from IREx letting them know their agreements are complete and they can indicate reliance.

Can sites that have signed SMART IRB use an institutional reliance agreement to rely on a Reviewing IRB?

Yes, if the SMART IRB Agreement is not offered by the Reviewing IRB on a study, then a site in SMART IRB can execute the Reviewing IRB’s institutional reliance agreement with the Reviewing IRB for that study. However, if the SMART IRB Agreement and an institutional reliance agreement are offered on a study, sites in SMART IRB will default to the SMART IRB Agreement.

Why do Single IRBs (sIRBs) use IREx?

sIRB use IREx as part of their reliance infrastructure because it provides a standard, centralized portal to capture documentation from relying sites that they are not able to capture or only partially able to capture in their electronic IRB system.

IREx offers these additional benefits to the single IRB:

• The ability to offload or delegate some tasks to the lead study team
• Standardized local considerations surveys
• The ability to electronically document the flexible elements of reliance, such as those in the SMART IRB Implementation and Documentation Toolkit

A standardized, familiar system to which relying sites can become accustomed

How does IREx help the Study Manager?

Although Study Managers (Lead Study Teams and Coordinating Centers) take on additional work under the national sIRB mandates, IREx provides a centralized tracking tool to automate tracking and standardize processes as much as possible.

IREx offers these additional benefits to the Study Manager:

• Study-specific dashboards to track sites progress completing reliance documentation
• User-specific dashboards to track progress across multiples studies
• On-demand consultation and training from IREx experts fluent in the sIRB regulations and process

Communication templates for informing participating sites about the process and steps to using an sIRB.

How does IREx help Participating Site HRPPs?

IREx provides a centralized system for documenting reliance on any sIRB, which can help establish standard sIRB processes.

IREx offers:

• Electronic documentation of reliance to avoid filling out paper-based letters of reliance
• Electronic documentation of local considerations to streamline documentation and avoid back-and-forth clarifications by email
• Clear next steps, requirements and standard notifications to take the guess work out of reliance
• On demand, 24/7 access to your site’s approval status on all studies in IREx

Standardized local considerations questionnaires to ensure local reviews are sufficiently documented, but in as few questions as possible

How does IREx help Participating Site Study Teams?

• A centralized documentation portal avoids sIRB-specific logins and system training

On demand, 24/7 access to your site’s approval status on all studies in IREx

What is a Combo Site?

A Combo Site occurs when one investigator or study team engages multiple FWAs (unique Federalwide Assurance numbers at each site) for a study.

Since a combo site is two or more FWAs, do Study Managers upload approvals for each FWA?

Yes, approval documents are uploaded for each FWA in the Combo Site. Approvals can be shared at separate times, as sites receive approval from the sIRB.

What’s the difference between a Primary HRPP and Non-primary HRPP for a Combo Site?

The Primary HRPP is the first point of contact for the sIRB and final sign off before a site is ready for sIRB review.

Are HRPPs at all FWAs in a Combo Site required to complete the HRP Survey?

Yes, given that each FWA must provide local considerations to the sIRB. However, the Non-primary HRPP can copy the Primary HRPP’s responses if that is appropriate. The Non-primary HRPP can also make edits and must sign off on the HRP Survey for their FWA.

Are HRPPs at all FWAs in a Combo Site required to validate the PI Survey?

No. HRPPs are no longer required to validate the PI Survey; however, HRPP Liaisons at each FWA in a Combo Site can view and edit, if needed, the PI survey for their FWA.

What if, as the sIRB or Study Manager, I add a site and PI to my study and later learn it’s part of a Combo? 

Not a problem – when the Relying Site HRPP registers for the study, they can add the new FWA and create their own combo!

If the site has already registered for the study, the Study Manager can add the additional site through the ‘Edit Participating Sites’ dialog. Simply add the new site and use the same PI name and email address. Do not check the box that the PI engages another site. IREx will automatically make them a Combo Site.

Does the PI of a Combo Site have to complete a PI Survey for each FWA?

Yes, given that each FWA must provide local considerations to the sIRB. However, the PI or Coordinator can copy and edit responses from another completed PI Survey for that study if that is appropriate.

What information is required to create a study?

Very little information is required to create a study (Watch this video):

• Study Title
• Study summary/overview
• Protocol version #
• Draft protocol
• Study sponsor

After this information is entered, the project is created. IREx will require the following information be entered before granting the Study Manager access:

• Indicate whether the Lead Site is at the SIRB Institution (Y/N)
• Indicate whether IREx is being used to capture local considerations (Y/N)
• Indicate which reliance agreement is being used (SMART IRB or other reliance agreement)
• Indicate whether an LOI is required (Y/N)
• Indicate who can use IREx to send instructions for executing the required agreements (lead study team and/or sIRB)
• Confirm and/or attach additional site instructions for completing the single IRB process
• Designate a primary IRB liaison/point of contact for the sIRB (pre-populated list of liaisons)
• Grant the IREx Study Manager (e.g., coordinating center/lead coordinator) access (First / Last Name, email)

The final step that must be completed by the SIRB is to confirm the study-specific reliance plan for the study.

Can study managers create studies?

No. Only Liaisons can create studies because this is used as a verification / quality check that their institution has agreed to serve as the sIRB for the study.

As the Reviewing IRB, how do I indicate what agreements are needed to rely on my institution for a study?

After creating the study, the Reviewing IRB indicates what reliance agreement(s) can be used by Relying Institutions in the IREx Study Setup. This is also where the Reviewing IRB indicates whether indemnification is required.

What institutions can become IREx members?

US-based institutions with a Federalwide Assurance (FWA). Check to see if your institution has an FWA here.

Can we use the SMART IRB Online Reliance System and IREx?

Yes, technically you can use both systems to support a single study, you may want to evaluate whether you need to use both. If you use both system, all of your participating site HRPPs will have to document reliance in two systems.

Do all participating sites have to be in IREx in order to use it for a study?

No. You can use IREx if not all the study sites are members of IREx. That is, you can use IREx with those who are members and use an alternative process for sites who are not members. Alternatively, sites that are not members of IREx can join as part of the requirements to rely on the SIRB for a study.

Can IREx only be used with the SMART IRB Agreement?

IREx supports use of the SMART IRB Agreement v1 and v2, and other reliance agreements (e.g., one-off MOUs) for the rare sites who are unable to sign onto the SMART IRB agreement.

Can IREx only be used with Trial Innovation Network (TIN) studies?

No. Any institution that is part of IREx can use it to support their single IRB (sIRB) study. See question, “What institutions can become IREx members?” above.

The TIN sIRBs utilize IREx to support sIRB review of all TIN studies. Use of IREx is required for all TIN studies, as is use of the SMART IRB Agreement.

How do I get started as the single IRB?

1. The Single or Reviewing IRB typically starts the process by educating the lead study team or coordinating center on the single IRB process and the tools used to manage the onboarding of sites (e.g., IREx).
2. Prepare “sIRB instructions” that can be distributed to sites by the lead study team/ coordinating center. IREx provides tailored instructions for sites that can be used (view instructions templates). These instructions typically cover the following information:

• • List sIRB & study contacts
  • Outline your reliance process for sites
  • Indicate required agreements
  • Describe consent form process

3. After the study has been submitted to your local IRB system and pre-review is complete, create the study in IREx.
4. Complete the IREx Setup, which gives the lead study team/ coordinating center (aka Study Manager) access.
5. Add the lead study team contacts (e.g., PI, coordinator) to IREx.
6. Complete the Study-specific Reliance Plan (SSRP).
7. *Optional*Upload the approval for the overall study/ lead site, once approved. Study Managers can and are encouraged to complete this step.

Once the lead site is approved, the Study Manager can use IREx to notify sites of access to the study. This notification will include instructions on how sites should retrieve the approved study materials from IREx so they can begin their local submission process. The notification will also include single IRB instructions.

For more guidance and tips check out the Reviewing IRB Quick Guide.

How do I get started as the Relying Site HRPP?

You will receive an email from IREx when you get access to a study; however, it’s okay to wait to provide documentation until you have your local submission.

Once you learn of a study on which you will be relying on an sIRB in IREx, we recommend the following:

1. Educate your local study team on your submission process (e.g., usual application vs. abbreviated)
2. After receiving your local submission, register for the study in IREx.
3. From the study page, use the IREx checklist to do the following:

• • Add your local study team
  • Indicate reliance on the sIRB
  • Document your local considerations in the HRP Survey, including uploading your local consent form

After these steps are completed, you have no other actions in IREx. You will receive emails when your site receives approval from the sIRBs.

For additional reference, check out the Participating Site HRPP Resources Page and the Relying Site HRPP video.

How do I get started as the Study Manager (Lead Study Team/ Coordinating Center)?

1. Identify a Single IRB (sIRB) for your study and ask about their sIRB process and tools used (e.g., IREx, Reliance Instructions, Consent Templates).
2. Request to use IREx so you can use its tools to ensure each site provides complete reliance documentation in an organized fashion and receives timeline notifications of new sIRB approvals (see the IREx Study Manager one-pager for more information you can share with the sIRB). Once the sIRB has agreed, submit your study to the sIRB via their local system.
3. The sIRB will create the study in IREx.
4. You will receive an email when the sIRB gives you access to the study in IREx. (Note: the sIRB may wait to grant your access until the lead study team is approved.)
5. Once you have access, you can upload and publish the Lead Site/Overall Study Approval, when available.
6. Once you have access, you can also add the participating sites to the study in IREx.
7. After the lead site is approved, notify sites of the study by pressing the “Notify & Grant Access” button which will allow the study team to login and retrieve the approval study materials.
8. As sites begin to complete their reliance documentation in IREx, you will track their progress in IREx. You will receive emails as relying HRPPs begin to document reliance and local considerations.

Once sites have completed their documentation in IREx, export the information and submit the site to the sIRB review.

After the sIRB has approved the site, upload their approval to IREx. The site HRPP & study team will automatically be notified.

For more tips, check out the Study Manager Step-by-step guide and view additional Study Manager Resources here.

How do I get started as the Relying Site Investigator or Study Team?

1. Connect with your local HRPP/IRB around their submission requirements when using a single IRB.
2. After the lead site has been approved, you should be granted access to IREx, along with instructions on how to retrieve the approved study materials (e.g., protocol, consents) from IREx.
3. Follow the process identified by your local HRPP. This is typically when study teams complete their local submission.
4. PIs and/or Coordinators can log in and complete the steps in their IREx Checklist.

View the Participating Site Study Team Quick Guide for more information on using IREx or watch the Intro to Single IRB Review & IREx Steps for Relying Site Study Teams.

What is the Study Manager role?

The Study Manager is someone from the Lead Study Team or Coordinating Center who is responsible for managing participating site access to IREx and overseeing participating site readiness for single IRB (sIRB) review.

In IREx, the Study Manager can do the following:

• Manage participating sites’ access to the study
• Notify participating site HRPPs and study teams of the study
• Track participating site readiness for sIRB review
• Export sites’ local considerations from IREx and submit them to the sIRB
• Upload lead site and relying site approval documents

View the IREx Study Manager Overview and the Study Manager Step-by-Step Guide.

What if I do not have a Study Manager for my study?

Although the single IRB process greatly benefits from a Study Manager, if there is no coordinator at the lead site, the PI can be listed as the PI and Study Manager.

The sIRB Liaison cannot be listed as a Study Manager on a study because the sIRB Liaison can already complete all the tasks of the Study Manager, such as adding participating sites to the study, downloading completed local considerations and uploading sIRB approvals for participating sites.

What permissions do Study Managers have in IREx?

• Add / remove sites and study contacts to the study
• Request sites complete required agreements for the study
• Grant sites access to the study (after lead site approval)
• Track site progress completing reliance documentation, including local considerations
• Export local considerations once all documentation provided 
• Submit sites to sIRB for review
• Upload initial Lead Site/Overall Study approval
• Upload relying site approvals
• Upload continuing reviews & study-wide amendments for the lead and relying sites
• Grant study-specific access to new site PIs (via site amendment) and coordinators

How do I get started as the Study Manager (Lead Study Team/ Coordinating Center)?

1. Identify a Single IRB (sIRB) for your study and ask about their sIRB process and tools used (e.g., IREx, Reliance Instructions, Consent Templates).
2. Request to use IREx so you can use its tools to ensure each site provides complete reliance documentation in an organized fashion and receives timeline notifications of new sIRB approvals (see the IREx Study Manager one-pager for more information you can share with the sIRB). Once the sIRB has agreed, submit your study to the sIRB via their local system.
3. The sIRB will create the study in IREx.
4. You will receive an email when the sIRB gives you access to the study in IREx. (Note: the sIRB may wait to grant your access until the lead study team is approved.)
5. Once you have access, you can upload and publish the Lead Site/Overall Study Approval, when available.
6. Once you have access, you can also add the participating sites to the study in IREx.
7. After the lead site is approved, notify sites of the study by pressing the “Notify & Grant Access” button which will allow the study team to login and retrieve the approval study materials.
8. As sites begin to complete their reliance documentation in IREx, you will track their progress in IREx. You will receive emails as relying HRPPs begin to document reliance and local considerations.

Once sites have completed their documentation in IREx, export the information and submit the site to the sIRB review.

After the sIRB has approved the site, upload their approval to IREx. The site HRPP & study team will automatically be notified.

For more tips, check out the Study Manager Step-by-step guide and view additional Study Manager Resources here. 

Can study managers create studies?

No. Only Liaisons can create studies because this is used as a verification / assurance that their institution has agreed to serve as the sIRB for the study.

Can a Relying Site document local considerations before they have executed all reliance-related agreements?

Yes. Sites are allowed to complete the HRP and PI Surveys in IREx while reliance agreements are undergoing institutional review and sign off. However, relying sites cannot indicate reliance until all reliance-related agreements are complete.

Who can complete the HRP Survey if our institution/ site does not have an IRB office?

The IREx Liaison(s) at your site can complete the HRP Survey in IREx. This is someone not closely associated with the conduct of the study at your site and may be the person that signed for your FWA.

Can the sIRB request that relying sites update their local considerations surveys in IREx after initial approval, e.g., for the life of the study?

Yes! If the sIRB is capturing local considerations in IREx, they can indicate whether they prefer to use IREx to request sites update their local considerations after applicable study changes.

When uploading a study modification (aka study-wide amendment) to IREx, the sIRB or lead stud team/Study Manager is presented with a list of changes that could trigger a re-review of local considerations by sites. If one of those items is selected, sites are asked to log into IREx to update the HRP and/or PI Survey, as needed. Sites are not required to log in if there are no changes or updates to report to the sIRB.

Find details on ‘turning on’ this feature in the Reviewing IRB Quick Guide.

Relying sites are encouraged to update their local considerations as policies change at their local sites as well. Any relying site can make these changes at any time.

Can I change my answer to the local context survey after I complete it?

Yes. The HRP & PI Surveys can both be edited in IREx throughout the life of the study. Though sIRBs can request relying sites update their local considerations as necessitated by study-wide amendments, relying sites are encouraged to update their local considerations as policies change at their local sites as well.

To make edits to a completed survey before your site has received initial sIRB approval, click on the survey / step in the IREx Checklist.

If your local considerations change after you have initial approval, click My Site Info on the study page, and select the appropriate survey. 

Regardless of when changes are made,

• HRPPs can edit the Human Research Protections (HRP) Survey.
• PIs, Study Team Members, or HRPP Liaisons can edit the PI Survey. Any edits will require a new PI Attestation.

Who at the relying site is responsible for uploading a site’s consent form – with any locally required language inserted – for the sIRB to review?

The consent form is uploaded by the PI or Coordinator in the PI Survey. PIs complete an attestation for the PI Survey, and it is their responsibility to ensure they upload the correct consent form(s), after it has been through any local reviews/verifications.

What type of reliance documentation is captured in IREx?

IREx captures the following types of reliance documentation:

• Basic Reliance Documentation
  • sIRB agreement completion status (e.g., SMART IRB, IAAs, IAIRs)
  • Study-specific reliance decisions
• Advanced Reliance Documentation
  • Study-specific local considerations for sites
  • sIRB approval documents for sites

In addition to Reliance Documentation, IREx also provides critical tools to facilitate the very important task of sIRB coordination. IREx supports sIRB Coordination by:

• Providing reliance instructions that detail the reliance process for sites
• Tracking site completion of the required sIRB documentation
• Capturing the information needed from sites for sIRB review
• Disseminating sIRB approvals to sites

What reliance documentation is required from my site?

If the Relying Site HRPP Liaison unclear on what information needs to be documented for the sIRB in IREx, refer to the IREx Checklist on the left-hand side of the study page. The IREx Checklist outlines all your steps to relying on the sIRB.

For example, if the sIRB is requiring Indemnification, this should be noted in the SSRP and the LOI will be listed under “Complete Agreements” in the IREx Checklist.

If the sIRB is capturing local considerations in IREx, HRPP Liaisons will see “Complete HRP Survey” in the IREx Checklist. Investigators will see “Start PI Survey” and “Awaiting PI Attestation.”

Can IREx be used to capture reliance documentation for two PIs separately conducting the study at the same institution?

Yes, if the PIs are part of separate study teams (e.g., a pediatric arm and an adult arm), but both participating on the study, both can be listed on the study. The Relying Site HRPP will need to list components in IREx and identify what PI is at each component (or one can be affiliated with the main FWA) to list the same FWA twice.

If a site on my study is no longer participating, do I need to close the site to remove them from the study?

Sites that are no longer participating on a study can be removed. We recommend the following, depending on the site’s level of participation in the trial:

For sites that didn’t receive initial sIRB approval, Reviewing IRB or Study Managers can simply delete the site from the Edit Participating Sites dialog (See our Add/Remove Participating Sites Quick Guide here for further instructions). This removes the site’s access and the record of their participation in the study. No email notifications are sent to the site when this occurs, as no further action is required.

For sites that completed the reliance process and received sIRB approval, Reviewing IRB or Study Managers can use the “Add site closure” button beside the site’s name on the Site-specific IRB Approvals tab. (See our Site Closure Quick Guide here for further instructions.) Sites will retain access to the study for 30 days, after which access is removed completely. The site’s HRPP and study team will be notified of the closure.

Who can close a site on a study?

Only Reviewing IRBs and Study Managers can close a site on a study.

Can I access a study after my site is closed?

After your site is closed in IREx, participating site HRPP liaisons and study teams retain access to the study for 30 days. All previously approved study documents will no longer be available for download. After 30 days, the study will be inaccessible to your site.

Can I issue a site closure for a site that hasn’t yet been sIRB approved?

No, you cannot issue a site closure for a site in IREx until after the site receives sIRB approval.

For sites that are no longer participating on a study, but did not receive initial sIRB approved, the sIRB Liaisons and Study Managers can remove the site from the Edit Participating Site dialog.

Who can close a study in IREx?

What study information is accessible after a study is closed?

Is a study deleted from IREx once it’s closed?

How can I access a history of my approvals documents after a study is closed?

What happens when the sIRB issues a study closure in IREx?

Who can create an EFIC study in IREx?

The single IRB or Reviewing IRB Liaison can create a study in IREx and indicate in the IREx Setup the study will capture an Exception From Informed Consent (EFIC). 

When does a relying site receive their accepted Community Consultation Plan (CCP) from the sIRB?

AFTER the relying site completes their steps for review which include, completing agreements, indicating reliance, and local considerations (Institutional Profile, HRP Survey, and PI Survey) the Lead Study Team/Coordinating Center will submit the site to the sIRB for review. Relying HRPPs and study teams will receive a notification from IREx and if applicable, receipt of stamped version of documents required to conduct the plan when the sIRB accepts CCP.

What is the benefit of using IREx for an EFIC study? 

IREx collaborated with EFIC study teams and single IRBs to develop an EFIC workflow within the IREx platform to support EFIC studies. The IREx platform’s EFIC workflow allows for flexibility as each sIRB and lead study team may already have processes in place for EFIC studies. SIRBs and Lead Study Teams can use IREx to disseminate Community Consultation Plan (CCP) templates, capture site-specific CCPs, CCP Summary of Results from sites, and track the progress of sites for an EFIC study.  

How does an EFIC study differ from a non-EFIC study in IREx? 

The IREx platform allows the sIRB and/or Lead Study Team to disseminate the Community Consultation Plan (CCP) template to relying sites, and in addition collect site-specific CCPs and CCP Summary of Results from sites. The IREx Checklist walks each user through their steps. For more information on using IREx for your EFIC study, watch this video or contact the IREx Administrators at admin@IRBExchange.org. 

Where can I upload my site’s proposed Community Consultation Plan? 

The Community Consultation Plan can be uploaded to the PI Survey by the study team AFTER the local HRPP has reviewed and provided any suggestions.

When can the study team start community engagement for an EFIC study? 

After your site is submitted to the sIRB for review, you will receive a notification from IREx when the sIRB accepts your site-specific Community Consultation Plan to begin conducting the plan. 

Can I turn on EFIC for an existing study? 

Yes – If your study is currently not collecting local considerations (LC), the sIRB can turn LC on in the IREx Setup and select EFIC for the question, “How are sites’ consent forms being handled?”. 
No – If your study is already collecting local considerations and a site on your study has registered, the sIRB will not be able to turn on EFIC for the study. Contact the IREx Administrators admin@IRBExchange.org for guidance. 

What helpful resources does IREx provide?

IREx offers Quick Guides to provide brief descriptions of how to complete common actions in IREx. Resources are available by user type. Click your user type below to visit the resources page that contains quick guides, training information, and videos related to your user type.

Single IRB/ Reviewing IRBs

Participating Site HRPPs

Lead Study Team/ Coordinating Center Staff (IREx Study Manager)

Participating Site Study Teams

IREx has helpful videos to assist with using IREx to support single IRB review documentation and communication. Visit the IREx YouTube Channel.

An IREx “Demo” site is available for IRB/HRPP Liaisons to practice using IREx as the Reviewing or Single IRB.  Contact us to request access to the IREx “Sandbox” where you can practice creating studies and using various IREx features before setting up your study in the live site.

What type of training does IREx provide?

IREx provides recurring twice-monthly webinars via Zoom for Study Managers (Lead Study Team/Coordinating Center staff) – sign up here. Recorded trainings are available for sIRBs, Relying HRPPs, and Participating Site Study Teams here. IREx also provides video training on using IREx to collect local considerations via YouTube.

IREx also offers one-on-one trainings for Study Managers and IRBs that can be arranged at a convenient time. Request a special training for you or your team here.

Who can upload the Initial Approval for the Overall Study or Lead Site?

The Single or Reviewing IRB Liaison or the Study Manager (Recommended) for the study can upload the initial study approval for the Lead Site. This is sometimes also called Overall Study Approval. Reviewing IRBs should communicate any IREx responsibilities delegated to the lead study team/ coordinating center or Study Manager. If you are a Study Manager, please check-in with the Reviewing IRB about your responsibilities for managing approval uploads for the study. See guide here.

Who can upload the Initial Approval for Relying Site(s)?

IREx Study Managers (recommended) and the Reviewing IRB Liaison for the study can upload initial approvals for sites that have ceded review. See guide here.

Who can upload the Continuing Review Approvals?

The IREx Study Manager (recommended) and Reviewing IRB Liaison(s) can upload continuing review approvals in IREx for the Overall Study or Lead Site and for Relying sites. Reviewing IRBs should communicate any IREx responsibilities delegated to the lead study team/ coordinating center or Study Manager. If you are a Study Manager, please check-in with the Reviewing IRB about your responsibilities for managing approval uploads for the study. See guide here.

Who can upload Study-wide Amendments?

The IREx Study Manager (recommended) and Reviewing IRB Liaison(s) can  upload and share study-wide amendments for sites on a study. Reviewing IRBs should communicate any IREx responsibilities delegated to the lead study team/ coordinating center or Study Manager. If you are a Study Manager, please check-in with the Reviewing IRB about your responsibilities for managing approval uploads for the study. See guide here

Who can upload Site Amendments?

The IREx Study Manager (recommended) and Reviewing IRB Liaison(s) can upload Site Amendments to IREx. Reviewing IRBs should communicate any IREx responsibilities delegated to the lead study team/ coordinating center or Study Manager. If you are a Study Manager, please check-in with the Reviewing IRB about your responsibilities for managing approval uploads for the study. See guide here

Can I upload a Study-wide Amendment or Continuing Review if all my sites are not yet approved?

Yes, approvals for sites that were not approved at the time of the Continuing Review or with a Study-wide Amendment can be uploaded after you have uploaded that approval. You will see the site in the Relying Site Approvals dialog, and their “Review Type” will still be “Initial Approval”.

Of note, if you are uploading a Study-wide Amendment that includes major changes to the protocol and consent forms, you should consult the SIRB to determine if any unapproved sites that completed local considerations (based on an earlier protocol version) need to update their local consideration surveys (HRP & PI Survey) in IREx based on the most recent protocol and consents.

A study team received an official approval from their local IRB to cede review to the single IRB. Do I need to upload that local approval notice in IREx?

No. The only approvals that are uploaded to IREx are approvals issued by the sIRB. Any local site notices or approvals are retained by the study team at the local site.

Why do I have to upload consent forms for sites (if applicable) at Continuing Review if nothing changed?

Most sIRBs add new approval stamps to consent forms at the time of continuing review. The newly stamped consents are uploaded to IREx so sites (1) know about the continuing review approval and (2) have the newest approved version of the consents.

Are relying site approvals uploaded at the same time as the lead site’s approval?

The overall study approval/ Lead Site’s approvals documents are uploaded separate from relying site approvals. The overall approval is uploaded first and appears on the Study-wide IRB Approvals tab. These documents are also presented on the Approval History tab for relying sites as “Global Documents”. Site-specific IRB approval documents (e.g., consent forms) are uploaded via the Relying Site Approvals dialog and are displayed on the Approval History tab for each site, along with the overall/global study documents for the study.

Can sites access the approval documents for other sites on the same study?

No. Relying sites can only access their site-specific documents and the overall/global study documents.

Who should be a Liaison for my institution?

The IREx Liaison is intended for IRB staff who conduct the day-to-day single IRB operations, as they will interact with IREx the most and receive most of the notifications.

How are Users and Liaisons different?

The Liaison is generally someone who conducts the day-to-day single IRB operations. IREx liaisons can create studies (as the sIRB) and register for studies when they are a relying site. IREx liaisons can also add other individuals as liaisons.

The User role can be assigned to individuals who may need to access information in IREx, but do not generally complete the steps in the reliance process (e.g., cede review, document local considerations, etc.). The User role is sometimes used for institutional leadership who may want to view aggregate information about how often their institution is the sIRB or a relying site.

Can I serve as the Liaison for two institutions/FWAs?

Yes. This can happen when (1) an institution has multiple FWAs (e.g., one for their children’s hospital and another for their university or medical center) and (2) sites have their own FWA, but either do not have an IRB or are closely affiliated with the IRB at another FWA-holding site that they would prefer provide reliance-related documentation (cede decisions and/or local considerations).

In these scenarios, IREx Liaisons can be affiliated with multiple FWAs/sites in IREx. We call this a multi-site liaison and have separate resources for this role because their user interface looks a little different. View the Multi-site Liaison Quick Guide.

What is the Study Manager role?

The Study Manager is someone from the Lead Study Team or Coordinating Center who is responsible for managing participating site access to IREx and overseeing participating site readiness for single IRB (sIRB) review.

In IREx, the Study Manager can do the following:

• Manage participating sites’ access to the study
• Notify participating site HRPPs and study teams of the study
• Track participating site readiness for sIRB review
• Export sites’ local considerations from IREx and submit them to the sIRB
• Centrally manage participating site approval documents and notifications to participating sites

View the IREx Study Manager Overview and the Study Manager Step-by-Step Guide.

What permissions do Study Managers have in IREx?

• Add / remove sites and study contacts to the study
• Request sites complete required agreements for the study
• Grant sites access to the study (after lead site approval)
• Track site progress completing reliance documentation, including local considerations
• Export local considerations once all documentation provided 
• Submit sites to sIRB for review
• Upload initial Lead Site/Overall Study approval
• Upload relying site approvals
• Upload continuing reviews & study-wide amendments for the lead and relying sites
• Grant study-specific access to new site PIs (via site amendment) and coordinators

Can Study Managers create studies?

No. Only Liaisons can create studies because this is used as a verification/ assurance that their institution has agreed to serve as the sIRB for the study.