PROJECT SUMMARY . Informed consent is legal and ethical requirement in health care and research that assures that individuals have the autonomy to make informed care and research decisions at their own volition, under no coercion or undue influence, and with reasonable understanding of the risks, benefits, and responsibilities of their decisions as they would in-person. Obtaining informed consent is a required yet challenging requirement that can impede participation in health care and clinical research. As a result of the COVID-19 pandemic, telemedicine has proven to be an effective way to deliver health and research services to patients remotely. Yet, providers and researchers (“consenters”) are still required to obtain and document informed consent from patients and research participants (“consentees”). Conventional informed consent approaches are not compatible with telemedicine presenting logistical, technical and security barriers such as travel and cost burdens, low comprehension, confusion and dissatisfaction, alterations in clinical workflows, compliance challenges, and concern over clinical equipoise. Teleconsent is an innovative and proven solution for obtaining remote informed consent developed by Doxy.me, Inc and Medical University of South Carolina. Teleconsent allows consenters to (1) meet and discuss the informed consent by video with consentees over a telemedicine platform, (2) share and collaboratively complete the consent document in real-time, and (3) generate electronically signed copies of the consent for immediate download by both parties. Our Phase I STTR research identified enhancements such as an improved mobile interface, interface for consenters to build and manage consent forms, and the ability for consentees to read consent forms in advance. Optimizing teleconsent to meet the demands of its users is critical, especially during these unprecedented times of the COVID-19 pandemic when most individuals engage in remote care and research. The objective of this Phase II proposal is to refine and expand teleconsent features and deploy them on a large-scale via doxy.me. To achieve this objective, we will refine prototype teleconsent enhancements via iterative user experience assets design and evaluate them employing formal usability methods (Aim 1); build an enhanced, scalable teleconsent interface using Large-Scale Scrum principles and test the new teleconsent features via a formal user acceptance testing program (Aim 2); and implement teleconsent at a large scale with doxy.me providers and researchers to determine performance and measure impact using quantitative metrics for success (Aim 3). Achieving these aims to expand teleconsent features and conduct a large-scale implementation will increase the capacity of consenters to improve the efficiency of the remote informed consent, which will improve recruitment, simplify consent workflows, and enhance telemedicine engagement.

PROJECT NARRATIVE . Teleconsent is an innovative way to obtain informed consent that combines the convenience of telemedicine with the benefits of in-person communication in a convenient and effective way. This proposal will extend the work started in STTR Phase 1 and allow doxy.me to scale teleconsent to over 750,000 healthcare providers and researchers on our platform.