5 Considerations for Evaluating an eIRB System
In addition to other responsibilities, human subjects protection programs (HRPPs) and IRBs are tasked with ensuring a research protocol’s lifecycle is compliantly captured. To help support compliance initiatives, an eIRB system can provide study teams with necessary guidance when submitting research requests to the IRB. Such a system may also assist in identifying the appropriate research regulations. With an eIRB system, all necessary information and data is in one location, making for a simplified process from protocol submission to review.
Regardless of the organization’s size or specializations, shifting from paper-based processes to electronic systems is a significant undertaking. This blog outlines five considerations when selecting an eIRB system for your organization.
Easy Setup and Configuration
We live in a world where regulations can (and will) change. The revised Common Rule went into effect in 2018 and changed several longstanding regulations and guidances; going forward, we anticipate other changes in research regulations, such as those recommended in the 21st Century Cures Act. IRB systems need to be flexible to help staff better navigate and support compliance with any future regulatory changes. eIRB platforms don’t have to be one-size-fits-all; research staff should have the opportunity to configure a system to their organization’s specific needs in a way that benefits them.
When evaluating, consider if a system has an option for smart forms, which are intelligent electronic forms, built with digital elements or logic, designed to gather research protocol information. Smart forms capture the pertinent information through initial study submissions, modifications, continuing reviews, and reportable events. The system should allow IRB staff to not only create new forms but also update a form’s existing logic.
Streamlined Processes and Workflows
Ultimately, an eIRB system should be able to streamline operational processes and workflows. For example, consider whether the system helps to improve your current turnaround times, or if fewer clicks are required to complete a common activity.
Additionally, the system should be transparent. Communication tools should be available within it, and multiple people should be able to access the system at any time, from any device. Keeping everything within the eIRB system helps move submissions along to the next point person without anything getting lost in an individual’s inbox during the review process.
Keeping everything electronic also makes it easier for staff to manage necessary protocol documents. Take the informed consent form (ICF) for example. Every time it’s updated or changed, the ICF can be archived or added to the history of the electronic folder in the eIRB system, with version updates intact. Staff are able to see previous ICFs and compare versions along the way. Contrast this with keeping ICF versions in a paper format or in a standard computer file folder: sifting through versions could not be done nearly as easily and efficiently.
Enhanced Human Subjects Protection and Compliance
With eIRB systems, a new protocol submission starts with the research team, including the principal investigator (PI) and study coordinator. From there, it typically goes to a general queue for the IRB analyst to pull. As they pull information, there’s a lot to consider as they analyze a new project, including:
- Eligibility for expedited review
- Eligibility for exemption
- Compliance with the Common Rule
- Compliance with FDA regulations
- Informed consent compliance with protocol and IRB policies
Using an eIRB system to its fullest extent will help this analysis process. The system should enable users to identify which regulations apply to the specific research they’re analyzing.
Additionally, smart forms can be configured to identify whether the study involves greater than minimal risk, includes minors, vulnerable populations, waiver of signed consent, is subject to HIPAA, if it involves a drug or device, etc. Depending on what’s been selected in the application/smart forms (such as greater than minimal risk research, expedited, or exempt, for example), research staff can respond to questions tailored to their specific submission. Making sure the system is set up to ask these questions will also help with institutional compliance initiatives, helping ensure all necessary information is properly captured. Staff can require answers to questions to ensure necessary information is collected at initial submission, rather than having to go back and forth with the study team.
Encouraging Transparency Throughout Study Navigation
During a study, research staff should see everything – from when the study was originally approved and when the activation process started, to when reportable events occurred. Looking at all pieces of information is important, and staff need a clear picture and understanding in order to navigate the study. The system itself should have one location for materials such as:
- Archived consent forms
- Investigator’s brochure
- Recruitment materials
- Device manual
Navigating these documents is important, as it gives the user the ability to see historical changes within a study and view currently approved study documents. Having an easy-to-navigate system ensures the correct approved study documents are utilized to properly conduct a study. It also assists with ensuring study documents are accessible for site audits.
Easily navigating a study will also make processes and procedures more efficient, since staff will spend less time digging through stacks of paper or reaching out to colleagues to locate certain documents. Additionally, by putting source documents in the eIRB system, it will show an electronic stamp of approval, current consent forms, and up-to-date documentation. Securely navigating a study, ensuring appropriate access, and transparency is key for study navigation.
Easy to Roll Out and Train Users
Even though there are many benefits to adopting an eIRB system for your organization, change can be difficult for many people. When implementing any system, it’s important to minimize the impact on HRPP staff members and those conducting research. When testing a system, consider going into the sandbox or test environment to play around with it so it makes sense to users. The system should have the capability to allow for user testing and validation. User testing and validation is key to a successful rollout as system bugs can be identified and fixed prior to rollout. The more it makes sense to users, the easier it will be to roll out organization-wide and train users.
Invite research coordinators, regulatory staff, and others who will be completing the application to focus groups where you can begin socializing the new system. In focus groups, subject matter experts should identify and discuss areas of change and how it will impact workflow.
When a system is updated, internal support documents need to be updated to align with system features. Having a clear understanding of the upcoming changes is critical to ensure that resources are in place to support users post rollout.
The final step in implementing an eIRB system is the rollout stage. Creating a rollout plan with minimal impact on users is key to a system’s success. During the rollout, subject matter experts and project managers should be available to answer system questions, address bugs, and facilitate communication between the eIRB vendor.
As this blog outlines, there’s a lot to consider when selecting an eIRB system. This shift can be a big undertaking for your organization. Seeking external expertise and guidance can be beneficial when shifting to an electronic system.