The research community is abuzz with the thrill of new technologies and the potential to streamline the clinical research process. From mHealth apps to electronic health records (EHRs), healthcare and clinical research are going digital.
Informed consent—a critical step in the research process—has fallen behind the research tech wave. But in the past few years, more and more organizations are exploring ways to employ electronic consent (eConsent) technology to improve the consenting process throughout the life of a study.
Three Attributes You Should Demand of Your eConsent Solution
Until recently, eConsent has met with resistance as researchers express skepticism of its ability to improve the research process and remain compliant. But it is possible to integrate electronic consenting methods without compromising compliance or radically modifying existing operations.
How? The first step to smoothly transitioning to eConsent is to know what to look for when researching new products. Here are three key product features that will ensure your transition to eConsent is smooth and complete, and that it pays off with improved participant engagement and compliance.
1: Significantly Reduces Consent Documentation Errors
As research grows more complex and participants are asked to consent to multiple study-related activities, sub-studies, and future research (each requiring its own signature), paper-based consenting is ripe with opportunity to miss a critical signature.
The cost of non-compliance is high: sites may lose opportunities to conduct research in the future and sponsors risk invalidating data.
Organizations looking to adopt eConsent should prioritize systems that do not allow documentation errors, such as a solution that doesn’t enable a participant to consent to the research until he or she has completed all required signatures and initials lines.
2: Keeps Data Private and Secure
There are myriad regulations designed to protect privacy and maintain data security, and not all of them align with each other. The right eConsent solution will be cognizant of those regulations and operate within the boundaries set by the collective body of regulations, not just some of them.
For example, any solution that is not compliant with HIPAA/HITECH standards should be taken out of the running. Additionally, FDA 21CFR Part 11 is a longstanding benchmark that deserves consideration when evaluating solutions.
3: Integrates with Existing IRB Processes
Technology is meant to enhance operations and maintain, if not improve, project timelines.
When shopping around for an eConsent solution, it is critical to carefully review each solution’s implementation and execution requirements. Ideally, the solution is consistent with existing review and approval processes, minimizing the time it takes to start using the solution and begin your study.
eConsent Is Easy
Embracing eConsent can seem intimidating, risky, or simply difficult. But organizations that know what to look for when evaluating possible solutions can be confident that they’ll find a solution—and a vendor—that makes the process worthwhile. Even better, they’ll move their research forward with improved compliance and, ultimately, greater participant engagement.