Making Informed Consent Digital: A Guide to eConsent

Introduction

eConsent is one of the central tools for shifting clinical trial operations to digital platforms. Not only does it represent a patient-centric solution for participants, it also offers benefits for sponsors, site staff, and ethical boards. In this article, we explain what eConsent is, how it works, and its benefits, and finally include some tips for sponsors and site managers to choose the right eConsent platform for their clinical trials.

Informed consent form (ICF) in clinical trials

According to the FDA, informed consent describes the whole process of informing a participant about a trial, culminating in them making a voluntary decision to be a part of a research study without coercion or influence.[1] This process should have involved the following aspects:

The participant was given complete information about the clinical trial
The participant understood the information given to them
The participant was allowed to ask questions
The participant was given time to discuss the research protocol with family and friends

These conditions ensure the participant is fully aware of the risks of the trial and the possibility that they may not benefit in any way from participation. Traditionally, the participant consents by signing an informed consent form (ICF). In clinical trials, this is usually done at the trial site, in-person, on paper forms.

However, consent doesn’t concern only enrollment. Participants may have to re-consent during a study to state their understanding and acceptance of procedures, treatments, etc. Re-consenting could be requested for various things such as sample collection, modifications to protocol, specific procedures/treatments, or even just to ensure they still comprehend the terms and risks of the study they are enrolled in.[2]

eConsent meaning: What is electronic consent and how does eConsent work?

Electronic consent (eConsent) in clinical trials refers to recording a participant’s informed consent via an electronic form rather than on paper, which could be done either remotely or on-site.

eConsent is a digital solution that can employ various multimedia components such as images, diagrams, audio, and video to engage with participants, sometimes in an interactive manner, to explain all the relevant information and ensure they fully comprehend the clinical trial. These platforms can also perform identity verification tasks, which becomes important when consent is obtained remotely through forms that could potentially be accessed by third parties.

In most eConsent form designs, participants don’t need to install additional software or apps on their systems. Direct web links (URLs) can be emailed to them, and participants can then follow these links to gain access to the form. Additionally, eConsent solutions can offer participants assistance, where site staff or monitors would guide them through the informed consent process via video conferencing.

Benefits of eConsent over paper-based consent forms

eConsent offers numerous benefits over its paper-based counterparts, for most actors involved in clinical research. Here are some of the benefits for participants, sites, sponsors and regulatory bodies.

Participants

Consenting can be done remotely, and facilitated via video call if necessary
Participants can be given access to a variety of multimedia they can watch/read/listen to at their convenience, giving them time to process what they have learned

Sites

Less administrative work due to digital records of signatures, with dates and timestamps completed automatically
Easier to keep track of re-consents

Sponsors

Easier to audit, gain insights into the system, and record and incorporate feedback, allowing for continuous updates to consent content
Makes enrollment easier and more interactive, potentially increasing recruitment numbers
May require higher initial investment, but tends to lead to reduced overall costs

Ethics boards, regulatory affairs

All data is secured digitally and made accessible through a web-based portal, increasing transparency and version control

How to choose an eConsent platform

When choosing an eConsent platform, there are several considerations to keep in mind before investing in one particular eConsent software:

Its compliance with Title 21 CFR Part 11 regarding electronic signatures (in the US, or relevant electronic signature regulations in other countries)[3]
Its history of IRB approval
Ease of use and accessibility on both computers and mobile devices, which determines if participants will be able to use it
User interface and design; more complex systems may require infrastructure upgrades and training for site staff
Ease of integration into existing systems; extended implementation plans can delay enrollments and possibly derail trials

The most cost-effective example of eConsent is a simplified PDF-based eConsent form. These can be supplemented with images, diagrams, and links to external websites to provide patients with more information. However, this type of eConsent form is likely best suited for simpler clinical trials.

At the other end of the spectrum, comprehensive eConsent platforms can include advanced features such as template libraries, version controls, remote monitoring, dynamic reporting, dashboards, a patient portal, and video support. Such platforms are ideal for complex studies involving large numbers of participants and/or requiring extensive multimedia supplements or patient-site remote conferencing to obtain informed consent. They are also a viable option for studies that may require re-consenting during the trial, which increases the complexity of associated administrative tasks.

5 eConsent platforms and providers to check out

If you are thinking of making the move to eConsent, here are five platforms and providers to check out (providers are listed in no specific order and their inclusion should not be construed as endorsement):

Conclusion

Investing in an eConsent solution can positively impact your clinical trial operations as well as patient experience. However, it is important to balance your actual needs with the complexity of the platform. As features increase, costs and complexity of operation tend to increase as well. It’s worth taking the time to analyze and evaluate the needs of your specific trial(s) to determine which functionalities you actually need and thereby choose the most practical option. You can also start with the basics and design simple PDF-based eConsent forms, but it is likely that the advanced functionality and proven usage record of established solutions will benefit your operations in numerous ways.