eConsent: What it is and Why your EDC Software Should Have it

eConsent clinical researchThe healthcare industry is not lacking in buzzwords or new tech terminology as of late. eConsent, short for electronic informed consent in clinical research, is one of the terms that seems to be here to stay. According to the Food and Drug Administration (FDA), eConsent refers to 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 participation.

With informed consent being a necessity in the clinical trials process, it only makes sense for eClinical providers to include eConsent functionality in their software. In this post, we’re unpacking the reasons why eConsent is a must-have component of electronic data capture (EDC) systems.

Eases the burden for clinical trial participants

Consent anywhere, anytime

Informed consent should not be as restrictive as signing a sheet (or several) of paper at a research site. Today’s technology makes it possible for trial participants to consent from virtually any location and have that consent tied directly to their own data. And when used remotely, eConsent gives patients more time to read through and consider important trial information in order to make educated decisions. 

Imagine sitting down at home with your phone, tablet, or computer to read consent documents at your leisure and perhaps consult family or friends in the process. Now picture yourself being handed the same document in the form of a stapled packet and then reading it and giving consent at the research site. Which is more appealing? The answer to this question matters greatly in the trial design process. If patient recruitment and retention rates dip too low, the trial cannot continue. 

Better understanding of the fine print

What’s the keyword in informed consent? Informed. The format of eConsent provides patients with clearer, more digestible information than what’s included in a packet of paper. Today’s eConsent documents might include hyperlinks or pop-ups with definitions of trial terminology. They may also display photos or videos that help participants gain a more thorough understanding of what a trial entails. This has the potential to lower study drop-out rates as patients have clearer knowledge of the trial, starting when they agree to participate. 

Lightens the workload for clinical research teams

Collaborate easily with others

Participants aren’t the only ones who benefit from mobile-friendly eConsent. Research professionals may also access studies on-the-go using the TrialKit mobile app, Clinical Studio’s phone or tablet-based companion. During study design in TrialKit and Clinical Studio, administrators enable permission levels for users – this includes access to informed consent data.

Tighter integration with study data

eConsent in TrialKit and Clinical Studio also works seamlessly with the rest of the system’s features and functionality. In other words, the process of consent is directly tied to the remainder of any data that is gathered on that participant – assuming the data is collected on the same platform. This adds the ability to update protocol and re-require consent if desired, or disable continued data collection if consent is withdrawn. In the end, a single participant could have multiple consents stored for different versions of the same study.

Track informed consent and re-consent

When setting up a study in TrialKit, certain configurations can save research professionals significant time and effort in keeping patients engaged and informed. After consenting, participants are automatically sent an email with attachments of the documents they reviewed, as well as the signature they provided. 

The system has a ‘track informed consent’ feature, which tracks whether or not patients have or haven’t consented to a trial. If consent was given, it ensures the patient has continued access to the platform and receives forms, updates, and more. The system is also aware of which patients did not consent and automatically removes them from the study. This feature makes deploying re-consent a much more automated process –  a previously challenging task for investigators and data managers. 

Reduced regulatory risk

Study participants’ consent becomes part of the audit trail the moment it is submitted. This is a cleaner and shorter process than obtaining informed consent on paper, which typically entails physical presence, one-on-one time, copying paperwork, scanning into records, and maintaining traceability manually.

Support from regulatory bodies, such as the FDA and Office for Human Research Protections (OHRP), continues to grow. A few years ago, they released guidance on electronic informed consent. Standards and documentation provided by regulatory bodies help to reduce some of the hesitancy research teams may feel when it comes to replacing paper-based informed consent with eConsent.

In an industry survey on eConsent, respondents identified cost to be the number one barrier to adopting eConsent. This is why eConsent capabilities are included in all Clinical Studio/TrialKit subscriptions. We believe budget should never hinder research teams from using the technology tools that facilitate better clinical trials. Want to discuss eConsent implementation with one of our product experts? Contact us today.