The newly released joint FDA and OHRP electronic Informed Consent (eConsent) guidance addresses ways in which eConsent can facilitate the subject’s comprehension of the information presented during the consent process, such as explaining scientific and medical terms and the risks associated with participation.
Informed consent is pivotal to a patient’s experience in a trial. Informed consent directly influences retention rates and quality of data. While patient recruitment can be extremely overwhelming, this can be mitigated through the use of eConsent. Information can be provided to the patient in a way that is more supportive to how adults and children process information when using an interactive format.
Using eConsent helps improve understanding of the stakes of participation. More informed patients mean higher retention, since informed patients feel greater agency in the study conduct, due to higher understanding of their role in the trial.
Thinking about eConsent? SAM reviews ways that eConsent supports and adds value to the recruitment process in this short CRF Health’s video: