Research compliance can be complex to navigate without the right tools. From human and animal subject protocols to hazardous materials and potential conflicts of interest, ensuring compliance manually is time-consuming and error-prone. The wealth of software on the market, which can undoubtedly benefit institutions, can also feel overwhelming—and most generalized software lacks the nuance to support the needs of an IRB.
Involvement from many departments and stakeholders, combined with intense scrutiny and the need to keep pace with policy changes, make compliance a complex and critical task. Institutions must reliably solve consistent problems—faster review, more straightforward risk identification, better progress tracking, and integrity preservation—without impeding the research.
Enter research compliance software designed specifically for IRB to improve compliance, increase collaboration, and reduce administrative burden. This article will dig into the three steps institutions can take to deploy successful digitized risk management for IRB.
Step #1: Build
First, focus on the needs of the institution and the stakeholders involved in the IRB process. Identify current pain points and metrics for success, recording the problems you intend to solve with software: speed of review, risk identification, collaboration and workflow, etc.
Conceptualize engagement
Identify the stakeholders who will engage with your IRB software: faculty, staff, students, or a combination. Are they first-time researchers, or do they have extensive research experience? The answers to these questions will dictate how you configure your applications and interface.
Additionally, consider the expectations of your stakeholders. What results do they hope to see from the software? For example, an institution with mostly first-time researchers might aim to shorten review time and make their application easier to understand and complete. Inexperienced researchers will also need to become more familiar with OHRP guidelines, so consider building ways for students to seamlessly access this information as they work.
Focus on collaboration
Of course, end users are only half of puzzle; the needs of the institution are the other half. Examine the pain points and bottlenecks of your current system and how they might be improved. Common hurdles include maintaining compliance, facilitating understanding and ease of use, shortening review time, and simplifying feedback. The objective is a streamlined workflow with shorter turnaround times and less back-and-forth for clarification.
Consider IT support at this stage, too. Look for software with its own support system, enabling students and faculty to contact the vendor directly for assistance rather than overburdening your internal IT and slowing response times.
Configure
Seek out configurable software designed to suit the needs of your institution without workarounds. List the functionality that matters most and find software that can accommodate those requests. The best software will change to support your IRB, not the other way around.
Inquire about the process for changing or rewording your application. If you anticipate changes, ensure you can implement them directly without waiting for a vendor to do it for you.
Step #2: Train
Once the foundation of your IRB workflow has been established , it’s time to train stakeholders on how to use it. Even the best software in the world won’t support your IRB without effective use and engagement, so take early steps to ensure clarity around updated processes.
Practice effective change management
It’s difficult to overstate the importance of regular, repeated communication with your stakeholders about the timing and nature of a software rollout. Consider including critical details about timeframes and next steps in all staff email signatures and IRB correspondence. Overcommunicate key dates in the timeline and the functionality users should expect.
Anticipate questions and draft crystal-clear communications, especially for use cases likely to get questions. For example, consider how the rollout will impact students in the middle of their IRB application when the changeover occurs. Simple, clear communication is paramount to effective change management.
Create training content
Live training sessions can be enormously beneficial but aren’t scalable over time. Whether you run initial live trainings or not, record webinars or training videos that can be stored and replayed. Supplement video training with downloadable support content users can refer to throughout the application and review process. For example, our Cayuse support library includes several long-form guides to serve as a reference and answer frequently asked questions.
Step #3: Succeed
With a solid foundation in place, you’re ready to take full advantage of your IRB software and its benefits. Like research, using software is a living process that should scale with your institution over time. Employ these strategies to ensure continued success.
Collect feedback
The simplest way to ensure ongoing improvement is to ask for feedback. Poll staff, faculty, and student users to get an overall feel for user sentiment. Gather detailed feedback about their likes and dislikes, any points of confusion, and what they enjoy most about using the tool. Don’t neglect opportunities in conversation with students, researchers, and faculty to ask for more information.
Understand what is being measured
Assess the metrics that matter to you and ignore the rest. For example, if you’re looking to improve turnaround time, gather a baseline metric before deploying new software and then compare your new turnaround time to your old one regularly to track progress. Anecdotal evidence from feedback interviews is incredibly valuable, but having the data to verify that feedback tells a much stronger story.
Ready to roll out risk management software for your IRB? Schedule a demo to learn more about how Cayuse Human Ethics can help digitize your workflow.
