Electronic Informed Consent: Definition
With the increasing use of digital health tools, electronic informed consent is becoming a key component in medical research and routine clinical care. The digital consent process refers to sophisticated software programs and standards, which provide interactive tools for obtaining informed consent. Note that according to the US Food and Drug Administration (FDA), “electronic informed consent refers to using electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent.” Since a vast majority of patients worldwide have access to mobile devices and a data plan, e-Consent provides numerous forms of interactions and customized options, which can boost self-paced learning and retention of information. Smartphone-based features, such as GPS options and telephone tapping, can improve knowledge acquisition and voluntary enrollment; all in accordance with international legal and ethical requirements.
Informed Consent in Medical Research and Ethics
e-Consent supports information disclosure, voluntary participation, and informed decision-making – three core elements in research ever since the adoption of the Declaration of Helsinki in 1964. Informed consent is fundamental in research ethics. The consent process involves giving information and obtaining consent prior to research. Clinical research that involves human participants must be accepted and understood by the participants themselves. In fact, informed consent is defined by the International Conference on Harmonization – Good Clinical Practice (ICH-GCP) guidelines as a process in which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.” Note that Good Clinical Practice (GCP) is international ethical standard guidance for designing, conducting, and monitoring clinical trials. The digital consent process, in particular, empowers patients and becomes a key component in patient-centered care.