Table 1.

Recommendations to guide implementation of electronic informed consent in biomedical research.

Concept	Description
Format	Implement audio, video, graphics (ie, icons, progress bar) and hyperlinks. Note: do not add audio that may distract participants, consider the length of the video, create understandable graphics and avoid hyperlinks to webpages with dynamic content Use simple, concise language and implement a bullet point format. Note: provide access to additional information if desired Give the possibility to research participants to highlight information that is difficult to understand in order to facilitate the discussion with the research staff Depending on the research study, make electronic informed consent available in multiple languages by using subtitles or translated text Implement a quality assurance process to check the input of the end user
Impact on understanding	Pay attention to the personal connection between the research participants and the research staff (also refers to security and trust) Implement quizzes to assess the participants’ level of comprehension. Note: do not let the quizzes feel like an evaluation Give the possibility to review information by using interactive technology or the printed electronic informed consent form Guarantee adequate support for people with limited computer literacy, visual/auditory impairment and people who do not have access to internet or computers
Acceptability	Collaborate with health authorities and ethics committees to create a framework for reviewing and implementing electronic informed consent
Security and trust	Implement controlled access systems for several stakeholder groups and pay attention to a secured electronic informed consent platform. Note: provide sufficient information to potential research participants about privacy aspects of the platform Make sure that the secure transfer of files is possible between stakeholder groups
Storage	Provide online storage of the informed consent Support online withdrawal with documentation of the reasons for withdrawal Pay attention to transparency regarding the use of participants’ health information and their right to control the sharing and use of this information Implement the possibility to update research participants frequently with information about preliminary results, follow-up studies and main outcomes
Content	Implement definitions Implement social annotations but mind the emotional force Implement a personalized approach (eg, by letting the participants indicate what kind of information they would like to receive)