Choosing Your Electronic IRB System: A Guide for Sites

Selecting an electronic institutional review board (eIRB) system is a critical decision for institutions looking to streamline their research compliance processes. Navigating the eIRB landscape can be overwhelming for researchers, human research protection program (HRPP) team members, and institutions alike.

The responsibility to manage submissions, track approvals, and ensure compliance with increasingly complex regulatory standards is a top priority for the research community. Transitioning from a paper-based approach or an existing eIRB system can introduce both opportunities and challenges, making it essential for impacted teams to understand an eIRB system’s intricacies.

Research integrity is paramount, and selecting the best eIRB system for your institution is crucial. An effective eIRB system should streamline and enhance the review process while ensuring adherence to regulatory requirements.

Choosing a system that does not meet an institution’s expectations can lead to administrative burdens, inefficient workflows, delays in the review and approval of research proposals, and can lead to noncompliance with regulatory requirements.

Assess Your Needs

Each institution has unique policies (or local laws), workflows, and user expectations to consider when evaluating an eIRB system. Identifying your specific needs for an eIRB solution is crucial to ensuring the selected system effectively supports your institution’s research compliance requirements and goals. Some steps to take are:

• Assess current processes: Begin by evaluating your current IRB processes and identifying pain points; as appropriate, this can also be completed for conflict of interest (COI), institutional animal care and use committee (IACUC), and institutional biosafety committee (IBC), especially if there are communication gaps between these offices. What are the major inefficiencies? Does the current process include burdensome workarounds and impacts your ability to efficiently complete reviews? What specific features are necessary for your institution? Would your institution benefit from a system with integration capabilities, the ability for customized reviews and process, or standardized templates and checklists?
• Assess current eIRB system: Evaluate your current eIRB system and identify if it meets your institution’s expectations. Does the current system include upgrades, enhancing its features and functionality? Will the system upgrades impact research processes beneficial to the institution, such as increased efficiency and improved compliance?
• Evaluate data migration: What historical protocol information will need to be transferred to a new eIRB system? Will the vendor assist with data migration efforts, or is the institution responsible for inputting historical data manually into the new system?
• Review current research portfolio: What is the volume of your research portfolio and what type of research is conducted? What are the current turnaround times for the existing portfolio and what improvements need to be made to minimize future review delays?
• Evaluate your ancillary review process: Does your research portfolio require ancillary reviews, such as radiation safety, COI, IBC, or scientific? Consider a system to help improve the efficiency and effectiveness of your institution’s ancillary reviews.
• Analyze institutional research strategy: Is your institution looking to grow research? Will your institution be expanding support for the types of research conducted – i.e., sponsor-investigator research? Will the new eIRB system have the capability to support the institution’s research strategy?
• Obtain stakeholder input: Engage with IRB members, researchers, and HRPP team members to gather insights into their needs and preferences. This will help in identifying must-have features and potential pitfalls. For example, what other systems (e.g., a clinical trial management system [CTMS], HR systems, learning management systems [LMS]) are stakeholders using? Is it beneficial to look for an eIRB system integrating with them?

Taking the time to identify and prioritize the needs of those who will utilize the eIRB system will not only facilitate a smoother implementation but will also contribute to a successful research program and goals.

Key Features to Look For

Each eIRB system has its own selling points; however, it’s important to focus on the system supporting the ethical oversight of research, the complexity of managing submissions, keeping track of approvals, and ensuring compliance with regulatory standards. Additionally, a system should enhance the overall user experience when submitting to the IRB. Some key features to consider include:

• Compliance and regulatory oversight: If appropriate, ensure the system adheres to regulatory requirements such as 21 CFR Part 11 and is compliant with protocol and IRB policies. The system should also include the ability to capture regulations applied to a research project such as Common Rule, Food and Drug Administration (FDA) regulations, and expedited and exempt regulations.
• User-friendly interface: A system should be intuitive. It is important for users to be comfortable using the system and complete tasks when needed.
• Customizable workflows: Look for a system allowing you to create unique workflows to fit your institution’s specific needs. For example, if a study includes radiation, will the system allow for automatic routing to the radiation safety committee? Also, consider if the workflows include automation to help streamline processes and minimize “clicks” (or manual work by a user) required to complete a specific task in the system. For example, can the system be set up to send out continuing review reminder notifications for protocols with an upcoming expiration date or annual check-ins for minimal risk research?
• Smart form creation: To help streamline the submission process, an eIRB system should include the ability to create and maintain smart forms. Smart forms are built with customizable digital elements or logic and are intended to capture protocol information. Creating customizable forms provides a standardized format for researchers to present their study protocols and supporting study documentation. In addition, this helps create consistency across various studies submitted to the IRB and drives higher quality applications.
• Study documentation: The system should be able to store historical study information that is easy to access, view, and download.
• Reporting: Metrics are essential for evaluating a system’s effectiveness, efficiency, and overall performance of the submission process. Look for a system with the ability to create and download customized reports on approval turnaround times, submission volume during a specific period, or types of studies submitted (e.g., studies involving children).
• Passive education: To help with user experience, look for a system including the ability to build in frequently asked questions (FAQs); help text; and quick links to regulations, guidelines, and internal policies.
• Integration capabilities: Check if the system integrates well with other institutional systems such as the COI program, grants management, research compliance, and ancillary reviews. Consider other areas outside of research such as reporting and analytics systems, as well as CTMS. An eIRB system with integration capabilities improves operational efficiencies, enhances compliance, and supports a more collaborative research environment.

Comparing eIRB Systems

Comparing the different eIRB systems available is a crucial, yet daunting, step. With so many different systems available, it’s challenging to pick a system best for your institution’s needs. With any new system, the intent is to have one to utilize over time, so finding a good fit will take time. Some key areas to consider when selecting a new system are:

• Vendor research: Compile a list of potential vendors and evaluate them based on features, functionality, customer support, and cost. Each vendor will have unique offerings, so it is important to evaluate systems with one another and with your current needs.
• Experience: Look for venders with a solid footprint in the eIRB space and consider their experience in working with institutions of your size. It is also important to know if a vendor can adapt to your growing research needs, such as the ability to accommodate an increase in research portfolio size.
• eIRB system upgrades: As technology evolves and the research landscape changes, a system should update to stay relevant. It is important to inquire about future system updates and how they support the ever-changing research environment.
• Demo requests: Schedule demonstrations with each potential vendor for a more hands-on experience. This will allow you to see the system in action and ask questions specific to your needs.

eIRB systems are not software solutions that will fix every broken process at your institution. Selecting an eIRB system requires deciding on which features you can and cannot live without.

Selecting an eIRB system is a significant investment for an institution’s research program. Seeking external expertise and guidance can be beneficial when looking into a new eIRB system. By following a structured approach and carefully considering the needs of your institution, you can ensure a successful transition to an efficient and compliant eIRB system.

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