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.

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, the other investigators or coordinators with access to the study can add you to the study. View Add and Remove Study Team Quick Guide.

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 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.

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
  • **New March 2020** Upload continuing reviews & study-wide amendments

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 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.

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. It is not the expectation that the local HRPP/IRB 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; and
  • Disseminating sIRB approvals to sites.

What reliance documentation is required from my site?

If you’re 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”.

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
  • **New March 2020** Upload continuing reviews & study-wide amendments

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.

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.