Teleconsent: A Novel Approach to Obtain Informed Consent for Research

Abstract

Lack of recruitment of qualified research participants continues to be a significant bottleneck in clinical trials, often resulting in costly time extensions, underpowered results, and in some cases early termination. Some of the reasons for suboptimal recruitment include laborious consent processes and access to participants at remote locations. While new electronic consents technologies (eConsent) help overcome challenges related to readability and consent management, they do not adequately address challenges related to remote access. To address this, we have developed an innovative solution called "teleconsent", which embeds the informed consent process into a telemedicine session. Teleconsent allows a researcher to remotely video conference with a prospective research participant, display and interactively guide participants in real-time through a consent form. When finished, the researcher and participant can electronically sign the consent form and print or download the signed document for archiving. This process can eliminate challenges related to travel and management of personnel at remote sites. Teleconsent has been successfully implemented in several clinical trials. Teleconsent can improve research recruitment by reducing the barriers related to informed consent, while preserving human interaction.

Keywords: Informed consent; clinical research; clinical trials; telemedicine.

Fig. 1

A screenshot of a teleconsent session. Users edit and complete the consent document together in real-time. Note that the photo signature has been completed by the participant. While in a call, the user can edit fields, select a paragraph by highlighting it and place signature at the same time.