5 Important Considerations for Evaluating IRB Systems

This post is part of a Bad Rabbit series on selecting RA systems:

So, you’re shopping for a new electronic IRB. Perhaps your volume has increased and you need a more efficient system. Maybe you’re looking to automize workflow and reduce compliance risk. Or maybe there’s finally enough room in your budget to pursue a much-needed upgrade.

Electronic IRB systems can make life easier. But before you start comparing systems, it helps to prioritize your office’s needs. To help you do just that, we’ve put together this list of the five most important things to consider when evaluating IRB systems.

We’ve intentionally left the list unranked, as priorities differ among institutions. Our recommendation: consider the points below, and then rank them from most to least important. Once you nail down your priorities, view the vendor list at the end of the post to learn about available options.

HRPP Toolkit Approach

Initially developed by IRB regulatory expert Jeffrey Cooper, MD, the Human Research Protection Program (HRPP) Toolkit is a set of living documents intended to provide guidance for policies, procedures and best practices in the conduct of human research.  Many research offices follow an HRPP Toolkit approach, using templates and standard operating procedures to create compliant IRB protocols.

If your institution takes an HRPP toolkit approach, you may benefit from an IRB system that specifically supports standard forms and templates. On the other hand, depending on submission volume and other institutional specifics, your office may not require an in-system HRPP Toolkit. if you work in a low-volume office you may find it possible to follow the HRPP Toolkit recommendations within a system not specifically designed for it.

Submission Volume

For a low-volume IRB office that provides compliance oversight for fewer than 150 open studies per year (including new, existing study modifications and continuing review), a relatively low cost, out-of-the-box IRB may be the perfect choice. As volume increases, you may benefit from a more robust IRB with system-to-system integrations and customization options. Consider:

  • How large is your staff?

  • What percentage of your volume is multi-site studies?

  • Do you need your IRB to be integrated with Clinical Trial, COI, or Grants systems?

  • Do you perform Clinical Trials that rely on external site collaboration?

Volume dictates need, and higher volume IRB offices need greater efficiency. If you find your resources stretched trying to keep up with increased volume, it’s time to consider an upgrade.

Data Migration Strategy

There’s no getting around it: if you’re shopping for a new electronic IRB system, you’re going to have to move some data around. At a minimum, you’ll need to establish a data migration strategy for your open protocols and address how you will be able to maintain view access for closed protocols. Will the existing system be sunset, forcing a migration? What’s your timeline for moving to a new system? Do you have the technical staff to perform a data migration, or will you need assistance from system vendor or an outside consultant?

Do Metrics Matter?

As with data migration, your metrics needs may align with your volume. In a large IRB office, comprehensive data can provide valuable insight to support, build, and manage operations. Performance metrics let you monitor workload, push for accountability, and make decisions supported by data—driving real, measurable change.

How important is it to have comprehensive metrics available at the click of a button? Reporting capabilities vary among research administration software providers; where you rank metrics can help narrow down your choice.

IT Capabilities

Similarly, your choice of IRB may depend on how much IT support you have. If your organization has a small IT staff offering minimal support, you may prefer to choose an out-of-the box, cloud-hosted IRB system that the vendor updates and supports. However, if you have a large IT staff or mature IT capability, it may make sense to go with a more complex IRB system, particularly if you identify compelling business reasons to customize.

Vendor Options

The right IRB system will improve workflow, reduce burden and compliance risk, and maximize the efforts of your research team.

The table below lists vendors that have offerings in the IRB domain, and is provided for informational purposes only. Please view product webpages for details. See any inaccuracies in the below list? Want us to add a vendor that you’ve worked with in this space? Let us know!

Product Description
Cayuse IRB Cayuse provides fully integrated, cloud-based proposal, award and compliance solutions. Cayuse IRB is an easy-to-use system for electronically preparing, submitting, and routing studies for IRB approval. Includes user-friendly configurable templates, CITI© integration, role-based dashboards, and automated notifications.
Huron IRB Huron’s IRB solution embeds compliant IRB operating practices from the HRPP Toolkit. Part of the Huron Research Suite, a comprehensive suite of software solutions for managing Agreements, Animal Operations, Clinical Trials, Conflict of Interest, Grants, IACUC, IRB, Safety Committees and Effort Reporting.
(formerly iMedRIS)
A software solution designed to help commercial, academic, and government institutions of all sizes integrate research operations under a single database platform. IRB Assistant includes electronic submissions, paperless review, meeting management, and customizable forms and workflows.
InfoEd Human Studies Part of web-based, integrated eRA suite offering over 20 modules in almost a dozen areas of Sponsored Projects Administration. Human Studies module provides full data integration and includes protocol development; customizable templates; compliance workflow supporting multiple reviews and levels of oversight; committee and meeting management tools; and electronic reviewer comments.
Key Solutions IRB Module Part of an integrated, web-based comprehensive software suite for Research Administration. IRB compliance module dictates a stringent process for compliance approval while minimizing effort from investigators, coordinators, and the committee. Offers centralized access; automated approval process; and reporting of forms, comments, attachments, notes, agenda, and meeting minutes for each protocol.
Kuali Protocols Kuali Research in the Cloud is open source, community-developed software designed to streamline the many tasks involved in pre-award, post-award and compliance management within a single, cloud-based system. IRB protocol system includes configurable system notifications and correspondence templates.
Streamlyne Research eRA Cloud-based RA system with customizable framework including compliance module with electronic protocol applications. The IRB Protocol document works as an electronic protocol application created by an investigator, which is submitted to the institution’s Human Research Protections Office and then reviewed by the Institutional Review Board (IRB). Tracks versions, amendments, renewals and impending expirations.

Still feeling overwhelmed trying to decipher which software product most closely meets your institution’s needs? Bad Rabbit can guide you through the product analysis and selection process, leveraging both our business domain and technical expertise. We don’t promote any particular software; we just want to help you find the right fit. Contact us to learn more.