Karen Maduschke

 of patients in critical condition are admitted to intensive care units (ICUs) to treat life-threatening medical problems. Often, acute care patients are ideal candidates for investigational treatments being evaluated in clinical trials. Enrolling often helps them access treatments not available to the public and contributes towards greater clinical achievements that can help save the lives of others.

While participating in trials may seem like a good idea, the process for consenting ICU patients is not simple. Informed consent is not a “contract” to join a trial but rather a process by which the principal investigator (PI) and patient, or their legally acceptable representative (LAR), discuss the potential implications of taking part in clinical research—which must be thoroughly understood. A signature is provided through the informed consent form (ICF) to validate that the proper process has taken place, and that the patient fully understands the potential risks, benefits, and outcomes of the trial.

This process can be especially complicated in acute care situations. But a well-designed, feature-rich electronic consent (eConsent) platform that enables a more flexible and hybrid consenting process can address those complexities to help patients receive life-saving intervention as quickly as possible.

Challenges of paper consent in ICU settings

Patients can be admitted to the ICU for any number of reasons, such as a stroke, heart attack, trauma, organ failure, or blood infection. ICU patients tend to have very diverse needs and demand more frequent examinations, specialized care, and ample technological support. In this setting, there is an increased urgency from care providers to take rapid medical action. So, when it comes to enrolling a critical patient in a clinical trial, time is of the essence.

As with any clinical process, multiple steps must be perfectly met to legally execute informed consent and enroll a patient in a study. Ideally, healthcare providers can walk the patient through the process to secure their consent to participate. But this is often challenging or impossible due to the condition of the acute care patient (for example, if they are unconscious, physically, or mentally impaired). If a patient is unable to provide consent for themselves, a family member or their legally acceptable representative (LAR) must provide authorization on their behalf.

Here is where we see one of the major drawbacks of paper consent. If a patient's LAR is not able to be physically present at the ICU, there is no way to secure a signature, so verbal consent is needed and often attained by connecting over the phone with an impartial witness from the hospital listening. This is not only extremely difficult to coordinate, but it also puts the LAR in a difficult position of making an important decision based on minimal details—exposing the site to risk in an audit and heightening the potential retraction of consent by the LAR. With the adoption of eConsent, hospitals and PIs can feel confident in providing access to clinical studies, knowing they can perform informed consent, track signatures in real-time and maintain an audit-friendly trail of records.

Powering better care with advanced technology

Unlike the traditional paper-based consent process, eConsent is a web-based platform that delivers an engaging and user-friendly consent experience. For example, the platform conveys important study information in a more digestible way using multimedia like video or clickable links that define terms quickly, helping patients and family members better understand the trial and be more confident in the decisions they take.

Some eConsent platforms also allow for remote consent. So, if the LAR is not physically present, the study doctor can send a link via email or text with a video that further explains the ins and outs of the trial—giving them an opportunity to ask questions and connect to an investigator if desired. Once the patient/LAR is ready, they can provide their legal signature electronically. The ability to provide electronic consent documents, particularly with multimedia, to a remotely located LAR can greatly enhance patient recruitment in these trials.

eConsent simplifies the process of educating patients and LARs on the risks and benefits of a clinical trial and what is required of them so they can confidently make an enrollment decision quickly. Ultimately, eConsent offers the flexibility to gain consent safely and efficiently in challenging situations. However, despite the many advantages, paper-based systems are still standard in most hospitals around the world, and many research institutions don’t understand how eConsent can be woven into the urgent care environment.

As an industry, it's time to prioritize better clinical trial consent processes—only then will we see better participation in clinical research that helps improve and even save lives in the acute care setting. The necessary innovation is already here, and it’s time for widespread adoption.

Karen Maduschke, senior director general manager, patient consent, IQVIA

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Complicated process of consenting ICU patients can be simplified with a well-designed eConsent platform. 




Karen Maduschke

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Advancing ICU Care with eConsent