Consent By Proxy: The Key To More Inclusive, More Reliable Trials

By Cal Collins

The inclusion of participants unable to provide informed consent is essential for the comprehensive applicability of clinical trial outcomes, particularly in studies involving vulnerable populations such as minors, cognitively impaired individuals, or critically ill patients. In these instances, a Legally Authorized Representative (LAR) must provide consent on behalf of the participant. However, the process of obtaining proxy consent is fraught with challenges, including complex documentation and data management issues, which can result in the inadvertent exclusion of these critical populations from research.

OpenClinica addresses these challenges through an innovative digital workflow designed specifically for LARs. This system enhances trial efficiency by seamlessly linking participant records with those of their LARs while maintaining distinct data management protocols. By simplifying data collection and ensuring regulatory compliance, OpenClinica's solution not only streamlines the consent process but also enhances the relevance and applicability of clinical trial findings to real-world clinical practice. This automated LAR workflow exemplifies OpenClinica's commitment to leveraging technology to optimize clinical trial processes, thereby ensuring inclusive research that can inform better healthcare outcomes for all patient demographics.