Achieving effective confirmation from the participant of their understanding and acceptance for their participation in a clinical trial is fundamentally critical in all regards.
It is good for the patient, good for the research and good for the sponsor.
It is also a legal requirement in most countries. A poorly informed participant may be a reluctant, poorly engaged subject resulting in questionable outcomes and early drop-outs.
Paper based informed consent is a onerous, time consuming clinical trial activity. Consent forms may stretch to 20 or more pages. Doctors are under time pressures. Even patients can be under doctor/patient pressure (also known as ‘doctor knows best’). Most investigator have the best intentions when explaining a clinical trial to their patients, but, can we assure that the message to patients on what the trial is, really gets across in the same way for each patient?
Early electronic equivalents to paper consent form prove that the use of an electronic medium could help improve the understanding achieved by participants as supported by an article in the New England Journal of Medicine. However, many early implementations have relied on dedicated tablets or custom software development. They were not scalable. They also add to the ‘site burden’ where they were added onto what was already a cluttered technology landscape for investigator sites.
That said, a dedicated site based tablet approach can be very effective. Trial subjects arrive at a site, and in a waiting room can read through the materials using an intuitive, responsive user interface provided by a tablet such as an iPad. However, this does not potentially give patients the added opportunity to read / review the materials in their own time, or, to involve family members.
Let us compare different modalities of eConsent function that we see and support as a eConsent solution provider.
Remote Patient / Site
In the most straightforward setting, we have a remote patient and a remote site. The patient is instructed to read and understand the eConsent materials through a task that appears on their dashboard (also manifested as an email or push notification) or on the Clinpal for Patients app. Once completed, they then must electronically sign the consent form. That signature process triggers a task to the investigator to counter sign it. Simple. This would typically occur following online recruitment but prior to receiving any further trial tasks such as diary completion. Reminder management needs to be used in this setting to trigger a recall for any patient that might have forgotten to complete the consent form.
In this setting it is also important to provide a feedback loop. At any point in the consent process, the patient must be able to ask a question. If the patient is remote, then the question should be presented to the investigator site. This recommendation was added to the FDA eConsent guidance of December 2016.
Assent + Consent
For minors – patients 13-18 in many countries, assent is required. The minor gives their assent as it is called, and the parent or guardian is invited to provide their consent on behalf of the minor. Again this is all task management, wrapped with reminders and once signed forwarded to check/counter sign by the investigator. Maintaining separate accounts, and copies of the eAssent / eConsent form ensure both parties have access to their own materials and eSignature.
With an onsite patient, things can be slightly different. For example at the time the patient is consented, they may well not have provided their email address, OR, the investigator cannot record their email address on behalf of the patient as they are not consented… Chicken and Egg scenario. We have 2 means to deal with this. 1). A simple permission to communicate / screen paper consent – not ideal as paper is involved again, or 2). using our Activation Code mechanism. The system generates an activation code that is handed to the patient. They use this to identify themselves to the system. They, and only they then log their basic PII and proceed to the eConsent process that could be on a tablet or computer at the site with assistance as required by site personnel.
The workflow from that point is similar to the above with the investigator able to review the consent responses (we use simple quizzes to confirm knowledge attainment). The investigator counter-eSigns the consent form that then triggers the system to proceed to the next step of the trial.
A few common mistakes are made in the implementation of an eConsent approach
1). Don’t take a paper consent form and put it on the screen.
Early adopters of eConsent have been guilty of sticking too closely to the content and form of a paper consent form. Understandable from an approval perspective, but it fails to gain the value that is achievable with the better medium. With an eConsent, you can;
a), Present a video presenting information from the Principle Investigator
b). you can show procedures in a video format to explain what they involve
c). you can provide quizzes to check that the patient has understood the materials to that point
d). you can forward questions to the site or investigator staff.
Leveraging these aspects is what differentiates the value of eConsent over paper consent.
2). Information sharing does not stop at the consent
Lets imagine you have a 2 years study that involves complex indications, treatments and some predicted adverse reactions. You do not want to rely on the memory of the patient to ensure they retain familiarity with the information in the consent form. Consider adding snippets of information through the course of the study. This helps the patient maintain compliance, increases retention as it avoids unexpected concerns leading to drop outs and, creates better trial data as a result. We provide this as an option on all our eConsent trials.
eConsent is not a module, a technology, an App or a tablet. It is part of journey that a patient takes from when they initially learn about a study through until they are provided with the study results. Don’t think just eConsent. Think patient engagement.
For further information regarding how to support a patient through-out their clinical trial journey, simply complete the following;