Electronic media for engaging patients in the research consent decision process

Informed consent has long been one of the central ethical tenets in human subjects’ research, and it remains a complex challenge for investigators and regulatory authorities today. Those difficulties include meeting the ethical principles outlined in the Belmont Report (respect for persons, beneficence and justice) while simultaneously creating an effective consent process that is informative, non-coercive and comprehensible to every potential research subject. Given rapid technological advances and the omnipresent internet in today’s world, the use of electronic mechanisms to obtain informed consent (eConsent) has become a subject of great interest and is rapidly being adopted. While eConsent may provide some new solutions to traditional informed consent issues, it also creates a host of new problems and challenges. This chapter discusses the various issues involved with the utilization of eConsent in human subject research and offers recommendations to improve procedural effectiveness and mitigate ethical challenges. Topics covered include the forms and media through which information is presented to the potential participants in a research study as well as the wide range of factors that may affect their participation including comprehension, voluntariness, literacy and length of the consent document.