FAQs

FAQs

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

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. Your access can also be added by your local HRPP if no other active study team members have access. 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’ sIRB liaison if you have questions about when you will get access to the study

The sIRB Liaison grants Study Manager access to studies in IREx. Access may be granted a 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 study manager 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?

Contact your local Human Research Protections Program (HRPP) or IRB. They grant the investigator access to the study. They may also grant a coordinator access. If you do not yet have access, they may be awaiting a local submission or more information about the study from you.

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 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 of 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?

Currently, IREx supports use of the SMART IRB Agreement.

In 2020, IREx will release new functionality to allow for the tracking of non-SMART IRB Agreements (e.g., one-off MOUs) for the rare sites who are unable to sign onto 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

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 for a study.

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

No, one set of approval documents is uploaded for the Combo Site.

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.

Can a Non-primary HRPP edit the PI Survey?

No. The Non-primary can only view the PI Survey. If changes are needed, the Non-primary HRPP should contact the Primary HRPP.

Is the Non-primary HRPP required to complete the HRP Survey?

Yes, given that each FWA must provide local considerations to the SIRB. However, the non-primary HRPP is able to copy the Primary HRPP’s responses if that is appropriate (e.g., the two FWAs are affiliated). However, the non-primary HRPP can make edits and is still required to sign off on the HRP Survey.

Is the Non-primary HRPP required to validate the PI Survey?

No. Only the Primary HRPP validates the PI Survey. If changes are needed, the Non-primary HRPP should contact the Primary HRPP.

Can you be a Combo Site with two different PIs?

Yes, if the PIs are part of the same study team, such as co-Is. Then, if one (or both) of the PI’s engages more than one FWA, then those sites would be a combo. However, if the PIs are separately conducting the study study (e.g., will have separate approval documents), then those sites are listed separately on the study.

What if I add a site and PI to my study and later learn it’s part of a Combo? 

Not a problem, and you don’t have to change anything. When the Relying Site HRPP registers for the study, they can add the new FWA and create their own combo!

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 whether an LOI is required (Y/N)

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.

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 or share “reliance instructions” (sample template) that can be distributed to sites by the lead study team/ coordinating center. 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. Upload the approval for the overall study/ lead site, once approved.

Once the lead site is approved, the Study Manager should send the approved study materials and reliance instructions to the sites so they can begin their local submission process.

For more guidance and tips check out the Reviewing IRB Quick Guide and the IREx Features for Reviewing IRB Liaisons video.

How do I get started as the Participating Site HRPP (Relying 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 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 Getting Started 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.
    • Verify the information provided by the PI in the PI Survey.

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 Participating 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 add the participating sites to the study in IREx. However, you notify sites of the study (using the “Notify HRPP” button on the Status Summary tab, until the lead site is approved.)
  6. After the lead site is approved, send/email the approved study materials to the participating sites study teams (outside of IREx) so they can engage their local IRB and prepare a local submission.
  7. Notify sites of the study by pressing the “Notify HRPP” button for each site.
  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 Participating 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 receive the approved study materials (e.g., protocol, consents) from the lead study team or coordinating center.
  3. Follow the process identified by your local HRPP. This is typically the when study teams complete their local submission.
  4. You will receive an email once you have access to IREx.
  5. PIs can log in and complete the steps in their Getting Started checklist.

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 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 completed all of 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
  • 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 relying site approvals
  • Upload continuing reviews & study-wide amendments

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 add the participating sites to the study in IREx. However, you notify sites of the study (using the “Notify HRPP” button on the Status Summary tab, until the lead site is approved.)
  6. After the lead site is approved, send/email the approved study materials to the participating sites study teams (outside of IREx) so they can engage their local IRB and prepare a local submission.
  7. Notify sites of the study by pressing the “Notify HRPP” button for each site.
  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 / quality check 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 who is not closely associated with the conduct of the study at your site and may be the person that signed for your FWA.

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

Yes. To make edits to a completed survey, click on the survey in the Getting Started Checklist.

  • HRPPs can edit the Human Research Protections (HRP) or PI Survey at any time before you have sIRB approval.
  • PIs can edit the PI Survey at any time before their HRPP validates their answers. After the PI survey has been validated by the HRPP, only the HRPP can edit the survey.

If your local considerations change after you have initial approval, contact the Study Manager or sIRB Liaison (listed at the top of the study page) to ask how these changes should be communicated to the sIRB.

Why does the relying HRPP/IRB upload the consent form for their site into the HRP Survey? Shouldn’t this be provided by the PI?

The consent form is uploaded by the HRPP/IRB into the HRP Survey to ensure the local HRPP has signed off on the local language provided in the consent form. We want to ensure the local investigator didn’t bypass their local HRPP review. When the HRPP uploads the consent to the HRP Survey, this validates to the sIRB that the appropriate local reviews occurred.

However, the local investigator or study team should provide the study’s consent form to their local HRPP/IRB for review. The local HRPP/IRB is NOT expected to complete the consent form for their local study team.

What type of reliance documentation is captured in IREx?

IREx captures the following types of reliance documentation:

  • Basic Reliance Documentation
    • sIRB agreement completion status
    • 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 Participating Site HRPP Liaison is unclear on what information needs to be documented for the sIRB in IREx, refer to the Getting Started checklist on the left-hand side of the study page. The Getting Started checklist outlines all your steps to relying on the .

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 Getting Started Checklist.

If the sIRB is capturing local considerations in IREx, HRPP Liaisons will see “Complete HRP Survey” and “Awaiting/Validate PI Survey” in the Getting Started checklist. Investigators will see “Complete PI Survey”.

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) in order to list the same FWA twice.

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

The Single or Reviewing IRB Liaison for the study can upload he initial study approval for the Lead Site. This is sometimes also called Overall Study Approval.

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) and can upload Continuing Review approvals in IREx for the Overall Study or Lead Site and for Relying site(s). 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?

 We recommend the IREx Study Manager to upload and share Study-wide Amendments for sites on a study. 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?

We recommend the IREx Study Manager to upload Site Amendments for sites. If you are a Study Manager, please check-in with the Reviewing IRB about your responsibilities 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.

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
  • 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 relying site approvals
  • Upload continuing reviews & study-wide amendments

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.

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 monthly webinars for sIRBs, Participating Site HRPPs, and Study Managers (Lead Study Team/Coordinating Center staff). IREx also provides video training on using IREx to collect local considerations via YouTube. Visit our home page and click “Sign Up for Training” in the carousel to find a time that works for you.

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.