What to Look for in IRB Software: 10 Essential Capabilities

Key Takeaways

• IRB software helps institutions manage human subjects research review, from protocol submissions to amendments, reviews, and approvals
• Effective IRB software should be flexible enough to meet the specific needs of your institution, both today and as they evolve, and should integrate with existing research administration systems
• Benefits of IRB software include accurate, accessible data, reduced administrative effort, and clear protocol histories for audit-readiness

Introduction

If you’re involved in the process of choosing IRB software for your institution, you already know this isn’t a small decision. It’s the software your investigators will use to submit protocols, your committee will use to review them, and your team’s primary reference point the next time an auditor asks for documentation. Choosing the right software will result in a smoother review process with fewer back-and-forth emails and a lot less manual work.

The good news is that you don’t have to guess your way through this process or go at it alone. In this blog, we’ll provide a practical overview of the key features that often matter the most, plus a few considerations worth evaluating before you make your decision.

What is IRB software?

Many institutions today are moving away from managing IRB (Institutional Review Board) submissions, reviews, and approvals with paper files and email chains due to common issues with manual workflows like delays, errors, and difficulty maintaining consistent records. Instead, they are opting to implement more reliable, time- and effort-saving IRB management software systems.

At a high level, IRB software helps institutions manage the human subjects research review process. At minimum, the software should support the review types your committee actually uses: exempt, expedited, and full board reviews. However, effective IRB software should also cover the full life of a protocol, from submissions all the way through to committee approvals.

What should IRB software include?

Different organizations may have different specific needs for their IRB software system. However, there are ten core capabilities you should look for when evaluating different options:

1. Support for all review types

Your system should handle exempt, expedited, and full board reviews without you having to bend your process to fit the software. Even if your committee structure is a little unusual, the software should still be able to cover your review requirements.

2. Full-lifecycle protocol management

IRB software should follow a protocol from submission through amendments, continuing reviews, and closeout, all in one centralized location. That means investigators and administrators aren’t hunting across five different tools to piece together a protocol’s history.

3. Configurable forms and workflows

Every institution’s IRB process looks a little different, and the software solution you choose should adapt alongside it. Look for the ability to configure forms and workflows to fit the specific needs of your institution, rather than rigidly pre-defined options.

4. Real-time protocol status visibility and tracking

Investigators want to know where their submission stands, and administrators want that same visibility without needing to dig through emails. Real-time tracking of protocol status cuts down on the “just checking in” messages and pings that derail you from your daily work. 

5. Automated notifications and reminders

Automated notifications and reminders keep protocols moving, nudging reviewers when something’s waiting on them and alerting investigators before a continuing review deadline sneaks up. It’s a small feature that saves a lot of administrative headaches.

6. Support for documentation and meeting minutes

An effective software solution captures documentation, meeting minutes, and reviewer comments as they happen, so you’re not piecing together a paper trail after the fact or managing a shadow system. This is a core feature for staying audit-ready. 

7. Data encryption and protection for sensitive data

Human research inherently involves sensitive data. Your IRB software should have the necessary security protocols in place so investigators and participants alike can trust that their information is protected.

8. Integration with existing systems

IRB software rarely works alone. Look for integration capabilities that let it connect with your other research administration systems or a solution that manages the full research lifecycle including grants management, so users don’t need to re-enter the same information multiple times.

9. Metrics and reporting that actually help

You should be able to pull metrics on review timelines, submission volume, and committee workloads without building a report from scratch every time leadership asks for an update. This feature alone saves hours of work pulling together the information leadership and regulators will inevitably request.

10. A strong, purpose-built support system

Software is only as good as the support behind it. Look for a solution backed by a support team that understands the processes and requirements of research administration; one who’s helped institutions like yours through implementation and beyond.

How do you evaluate IRB software?

A little structure goes a long way here. Here are four practical steps that tend to help while vetting different vendors:

Start by evaluating your current process

Before you look at a single demo, map out how a protocol actually moves through your institution today,  who submits, who reviews, who signs off, and where things tend to get stuck.

Communicate your workflow, including your pain points 

The more you can share with the solution provider you are evaluating, the better you will understand what can be configured to how your team works.

Talk to people who’ve already made the switch

A quick conversation with an administrator at a similar institution can give you practical information about a solution, the vendor’s implementation process and support systems, and how the software evolves with their organization.

Think about potential changes in the coming years

Consider your current needs alongside where your research program is headed, especially if submission volume is growing. Your IRB software should be capable of adapting with these changes. 

What are the benefits of electronic IRB software?

Institutions that move from paper or email-based IRB processes to electronic software tend to notice the same things: submissions move faster, fewer things fall through the cracks, and there’s finally one place to look for a protocol’s full history. For administrators specifically, it means less time spent chasing down protocol statuses and more time supporting researchers. Centralizing documentation also means that teams using electronic systems are better prepared for audits.

If you want a closer look at how good documentation habits support audit-readiness more broadly, our blog 3 audit trail essentials for research compliance is worth a read.

Where IRB software fits into the bigger compliance picture

IRB software rarely exists on its own island. Most research administrators are also juggling conflict-of-interest disclosures, IACUC and IBC protocols, and other compliance responsibilities across the institution, and the strongest programs tend to avoid siloing these processes. Read about the best ways to identify and reduce compliance risks for more information on spotting and closing gaps before they become a problem.

Human subjects research also raises questions that go beyond process and paperwork. Check out our blog on 3 key ethical considerations in healthcare research for a closer look at how ethical review connects to the systems built to support it.

Finding the right fit for your institution

At the end of the day, choosing IRB software isn’t really about finding the system with the longest feature list, it’s about finding the solution that fits how your institution actually operates today, and will continue to work as you grow. The capabilities above are a solid starting point, but the right answer will still come down to your review volume, your committee structure, and the other systems your IRB process needs to talk to.