Electronic informed consent (eConsent)

What does Electronic informed consent (eConsent) mean in clinical research?

FDA and the HHS Office for Human Research Protections define electronic informed consent (eIC) as the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts and interactive websites, to convey information about a study and to obtain and document informed consent. Their joint guidance was issued in 2016.^⁠[1]

The guidance says an eIC may be used to provide the information usually contained in the written consent form, to evaluate the participant's comprehension, and to document consent, and notes that interactive electronic processes may help participants retain and understand the information.^⁠[1] Comprehension matters for enrollment because consent is the gate between an interested patient and a screening visit, and a patient who leaves with open questions may not come back.

Practical note: eConsent changes how information is delivered, not who is responsible. The consent process is still conducted by the investigator or site staff the investigator delegates.^⁠[2] Consent is Bond's comprehension support: plain-language explanations and patient Q&A, with escalation to staff, while the site obtains consent.