eConsent includes multimedia components which can be used to develop an interactive and engaging informed consent experience, offering flexibility for diverse learning styles (e.g., auditory, visual).
Empowers patients to make informed decisions through the use of interactive, multimedia components.
Enables the improved quality and efficiency of clinical trials through insight into the patient experience, improved data quality and a fully electronic system.
Informed consent forms (ICFs) have become increasingly complex, technical and more difficult for patients to understand clinical research objectives. With complicated study designs, variability in literacy levels and cultural diversity, the development of ICFs have become overly intricate and an inefficient means for conveying information about a trial to the patient. Today, study sponsors must find new ways to ensure that potential patients are fully informed, despite the multitude of information provided, traditionally on paper.
Ultimately, eConsent offers the following potential benefits:
- Better inform participants to empower them to make knowledgeable decisions using interactive multimedia components
- Enabling the improved quality and efficiency of clinical studies through insight to the participant experience, improved data quality and a fully electronic system
Electronic informed consent (eConsent) provides the same information, but in an electronic format that may include multimedia components such as images, audio, video, diagrams, reports, call out boxes and a digital signature which may aid the consenting process. eConsent is not meant to replace the important discussion between the participant and site staff, as the site will continue to play a critical role in the consenting process.
eConsent has the potential to improve the consent experience, increase quality, and reduce regulatory inspection findings. For a summary of some benefits affecting patients, sites, IRBs, HAs and sponsors, see the figure below. These benefits are based on member company experience, stakeholder input, and hypothesized advantages from using more technologically sophisticated processes. While experience or logic suggests that eConsent can deliver these particular benefits, attaining these specific benefits may vary across companies and across studies and, depending on the circumstances, some or even all of the specified benefits might not be realized. The degree of benefit will be directly related to the components selected and their fit within a specific context.
eConsent uses an existing technology in a novel setting
- Limited understanding of the potential of the different eConsent multi-media components and their development on a global level
- New technology can be intimidating and may have “room for improvement”
- Implementation requires time as it is associated with a change in behavior and way of working
- New technologies in some cases require high initial investment and resources
There is a limited guidance or considerations for the use of eConsent
- Limited experience for internal and external implementation
- Limited established regulatory guidance and IEC/IRB review/approval requirements
- Acceptance of eConsent multi-media components (e.g. digital signature) might vary at the country or site level
Looking for more?
For more detailed information, including benefits and guidance for implementation for the individual multimedia components refer to the TransCelerate eConsent Implementation
More About eConsent
TransCelerate's solutions are designed through a collaborative process in which thought leaders from member companies participate. Integral to the development of these perspectives is our engagement and robust partnerships with organizations across the ecosystem.
Thank you to the patients, sites, ethics committees and institutional review boards, clinical research organizations, health authorities, and technology providers that have helped us create these valuable insights on eConsent for the industry.