eConsent in Clinical Trials: 3 Questions Answered by experts

eConsent in Clinical Trials: 3 Questions Answered by experts

eConsent is one of the most established digital tools advancing clinical trial conduct. While it has gained trust from medical researchers and companies worldwide, some clinical research sponsors still have questions about using electronic forms. This is expected, as traditional paper-based forms were the only method of consent acquisition for a long time.

In this article, we answer 3 common questions we hear from our clients when we introduce our digital-first approach to clinical research. After briefly explaining what electronic consent is, we will talk about its benefits, how it differs from digital signature and how it compares to traditional consent forms. Save this blog for future reference and share it with someone who might be interested in the subject.

What is Electronic Consent ?

eConsent, or electronic consent, is a digital form of obtaining consent to participate in a clinical trial. It refers to all the stages of the process, from reaching potential participants to recording their formal agreement to share their personal health data.

The electronic consent solutions often include tools to build and share information documents about the objectives and potential outcomes of the trial, on-line forms, digital signature options, and real-time monitoring of consent acquisition. Electronic consent can also be used to enhance informed consent with glossaries for patients, reminders and knowledge review.

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#1 What are the Benefits of Using eConsent ?

Switching from paper-based forms to electronic consent acquisition has many benefits, mainly because it is a more comprehensive solution. This means that while traditional consent processes are limited to a paper document and the patient’s signature, the digital solutions can include many other features that allow for a more informed and ethical consent acquisition.

This is a short list of some of the benefits of using eConsent :

  • It is a safer way of collecting, securing, and handling the patient’s personal data. Electronic consent solutions usually have built-in data management systems that can protect personal information in a way that paper documents stored in folders cannot. Moreover, digital storage is not subject to risks that physical storage is, such as fire incidents and misplacing of documents.
  • Because it is not limited to a few sheets of paper, electronic consent solutions can include as many information as it is necessary to ensure participants are well informed about the trial they are about to join. Information guides can be totally customizable with no extra costs by using a template and adapting it to different participants groups with different needs. Some people may need a different design to be able to read, or require translation and explanation of less known terms, for example.
  • Electronic consent solutions give researchers more freedom to design information documents and signature sheets that are interactive and help with patient engagement. This can even be done more quickly than writing a traditional consent form.
  • With eConsent, patients can read and review information documents and signature forms on their own time, using their own devices. This adds convenience but also improves informed consent, since participants can take their time to formulate questions and alleviate all of their concerns before signing.
  • Having a document that can be easily shared with all stakeholders ensure that everyone involved in the clinical trial is on the same page, facilitating communication and making the process more efficient.

#2 Are eConsent and Digital Signature the Same ?

The short answer to this question is “no”. Electronic consent and digital signature are not synonyms; however, these expressions are often used as such. Almost all of electronic consent solutions have a digital signature feature, but not all digital signature systems can be classified as electronic consent.

As it may have become clear from reading the benefits in the previous section, electronic consent involves a lot more than just a document to sign. It is a whole system designed to reach participants, inform about the trial, engage patients and communicate with them, and, finally, obtaining their digital signature.

An important detail about the difference between eConsent and eSignature is that while there is not a well-defined regulatory framework for the use of the first, some countries have very specific requirements about electronic signatures and may even not accept it. Sponsors and researchers should have this in mind and consider the relevant requirements when selecting a CRO to partner with.

#3 Is eConsent Better Than Analog Forms of Data Collection ?

When we have highlighted so many benefits of using electronic consent, it is clear that we support its implementation rather than of a traditional consent process. Of course, paper-based forms have its advantages too and can be efficient, after all, they have been part of successful clinical trials for many years.

However, in the last few years, we have seen more and more companies making the shift and switching to totally digital consent process. The possibility of not having to maintain huge storage units only to secure patient data and avoiding the risk of misplacing an important document are already enough to convince some companies to adopt eConsent and never look back.

There are challenges, of course, to implementing a new system for the first time. But even the need to train staff and guide patients to use digital solutions do not make traditional consent systems preferrable. We can say with confidence that electronic consent solutions are improving the efficiency of clinical trials and are likely to completely replace analog forms of data collection.