Within any area of clinical research, the term “consent” is a vital one. It’s very important for clinical trial participants to understand what they’re taking part in and give their legal, informed consent for any minor risks they may be exposed to, and modern technological advances have improved this area along with several others in the medical research world.
At AGA Clinical Trials, informed consent is always a top priority within any of our clinical studies – there is no situation where we will proceed with a study without proper consent from all participants. One technological innovation that’s benefitted this area in particular is the advent of what’s known as “eConsent,” an electronic form of consent that’s been growing in popularity over recent years. This two-part blog series will dig into what eConsent is, plus how it benefits not only trial participants, but also clinical researchers during the trial process.
eConsent Definition and Purpose
Per the Food and Drug Administration, which has created a full document governing the use of eConsent, the term is defined as follows: “The use of 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” for trial participation.
As more and more clinical providers have begun to use software throughout their processes to help document and track important data, it only makes sense that eConsent is gaining in popularity. It can now be found as an option in virtually all modern study formats. Our upcoming sections will detail how it benefits trial participants in particular.
Trial Participant Convenience and Time
For starters, eConsent opens up the ease and convenience of giving informed consent, an area that had previously been relatively restrictive. Instead of being absolutely required to sign sheets of paper for informed consent, technology allows participants to give consent from anywhere, allowing them more time to read and digest the information without any pressure on them.
In addition, eConsent software allows the consent of a given participant to tie directly into their own data profile. Between all these elements, eConsent is actually playing a big role in maintaining trial volunteer levels through improving simplicity and convenience for those signing up.
On top of making things more convenient from top to bottom, eConsent also allows for greater understanding of the information they’re digesting. Informed consent is just that – informed, and anything that allows patients a better idea of what they’re signing up for is valuable. eConsent documents can contain elements like links, pop-ups, photos and even videos to help potential participants understand the full scope of the study, features that simply weren’t available in previous iterations of informed consent.
For more on how eConsent benefits both trial participants and researchers, or to learn about any of our clinical studies, speak to the staff at AGA Clinical Trials today.