Informed Consent Needs an Overhaul

By Gunnar Esiason, Principal, Thought Leadership, Florence

Like the fax machines still found in health systems around the country, the informed consent process inside clinical trials feels like an ode to an older generation. For those of us living with chronic terminal conditions, we want care delivery to be fast, efficient and safe. 

For many patients like me, clinical trials are seen as a care option, and while they may be safeguarded, they are in no way fast and efficient. And no process more clearly embodies the administrative bureaucracy and time waste more than the informed consent process that comes complete with pages and pages of dense medical jargon.

Informed consent is one of the most important parts of a clinical trial. It is when a prospective participant learns about the nuances of the study that they will play a key role in. During the process, participants are made aware of the potential risks and benefits of their participation, the time commitment required, and just about everything in between.

I’ve consented to several interventional clinical trials over the last decade because I live with cystic fibrosis (CF) and each time I have it’s felt a little bit like a stuffy lecture. At its worst it can come across as condescending and demoralizing. My favorite part is when the coordinator explains CF to me in painstaking detail as if I have no familiarity with the disease that has characterized so much of my life. I’ve lived with CF for almost 32 years, so yes, I understand that a declining lung health can lead to some serious stuff. In fact, that’s usually among the reasons why I volunteer for trials in the first place!

One of the most common criticisms of  informed consent documents is that they are long and overly detailed. The consequence of this verbosity is multifaceted, but a few issues are painfully obvious. One of them is the time required to walk through the consent with individual participants. 

Consent forms can range between 5,000-12,0000 words and are often written at an 11th grade level. As l protocols become even more complex, one can only assume that the word count and jargon will only increase. So how can we ensure that patients have the time and information they need to make an informed decision? 

Not only is the time spent consenting into a trial a concern for anyone with a busy life (presumably filled with illness like I’ve experienced), but a recent review went as far to suggest that the current consenting practices compromise comprehension for participants, which “undermines” ethical standards for clinical trials. It’s especially worrisome that risks and benefits of clinical trial programs seem to be among the components of informed consent that are not comprehended.

Patients with hard to treat conditions need the science to move forward at breathtaking speed into a realm of technological complexity we could only dream of a few short years ago. But if that’s so, then clinical trial infrastructure and processes need to keep pace with a key focus on the patients at the heart of trials. For informed consent, that means simplicity, cohesiveness and comprehension.

The former is a challenge to the industry to do a better job of communicating with patients, advocates and sites more clearly and succinctly, while the latter requires optionality.

Technology can augment the consent process. Solutions like eConsent that allow participants to consent from their home, rather than face an additional visit to the trial site. eConsent can also  turn the consent form into a living document filled with learning aids and prompts. Historically, comprehension has relied on a participant’s willingness to ask questions, but an interactive consent can fundamentally alter the ease with which a consent document is read.  Forward thinking IRBs are recognizing the need for change.

Informed consent needs to feel less like signing a mortgage, and more like fundamental human-centered care. More and more frequently people are seeing electronic, easy to read documents in other parts of their lives, why must clinical medicine feel so different? 

Informed consent within clinical trials programs is crying out for some reform, and the first step should be to help patients better understand what they are getting themselves into.

Gunnar Esiason is a cystic fibrosis and rare disease patient leader who is passionate about early-stage drug development, patient empowerment and health policy. Professionally, he developed a patient engagement platform for a medical nutrition company and built a venture philanthropy practice at the Boomer Esiason Foundation. He has consulted on clinical trial development, a real-world evidence population health study, and a cystic fibrosis-specific mental health and wellness screening tool.