While many people indicate “I have read and agree to the terms and conditions”, very few actually take the time to read through everything to truly understand the small print. One journalist estimates if we actually read legal agreements in their entirety, it would take up to 8 hours per week. Instead, we indicate we’ve read the terms and conditions and hope there’s nothing unforeseen in the small print.
In recent years, we have become conditioned to ignore the implications of providing our consent and instead, skirt past the tedious detailing. This may explain why informed consent is one of the most challenging, complex legal and ethical aspects of a clinical trial. The informed consent process serves two essential purposes:
- To provide information about the trial protocol to potential participants so they can make an informed decision on whether to take part
- To form a legal agreement between the trial sponsor and the patient
Because of the legal element, informed consent forms are typically lengthy and highly technical documents.
To achieve truly informed consent, four criteria have been identified:
- Information disclosure
There are numerous challenges associated with this, including the informed consent document is lengthy and today’s trial protocols are more complex than ever. There are many different trial types, including stratified, multi-arm and adaptive trial designs, novel types of treatments, and parallel translational studies. Additionally, potential trial patients vary in terms of their sociocultural diversity, levels of literacy, and physical and mental capacity.
Are we genuinely achieving informed consent?
In a survey of nearly 300 cancer trial participants, about 90% said they were satisfied with the consent process and most participants considered themselves well informed. But when questioned, a large proportion couldn’t recognize many of the terms used throughout the protocol. More than a quarter of the group did not realize they were not guaranteed to benefit from the treatment themselves, and 70% of participants did not recognize the unproven nature of the treatment.
This study, conducted in U.S. cancer centers, probably only scratches the surface. Achieving full understanding of a trial protocol may be more challenging in developing countries, where participants may have less access to education. Additionally, they may not be familiar with medical research or have their own cultural viewpoints on disease.
Another study looked into 103 clinical trials and found up to 75% of participants indicated they fully understood the consent process provided them freedom to withdraw at any time. However, only 54% of participants in one sample could recall at least one risk of the trial, and only 53% stated they understood the placebo. In these cases, it is even more important to make consent forms clear and accessible no matter the audience.
Although it’s recommended to simplify trial consent forms towards an eighth-grade level, in practice, this is not happening often enough.
Even if the informed consent form provides the participant with excellent trial information, researchers must take their competency level into consideration when giving informed consent. Age, mental and physical health, and the current disease stage all affects the participant’s ability to make a rational, autonomous decision.
How can we achieve informed consent?
Ideally, the informed consent process should mark the beginning of an ongoing engagement between the participant and clinical site staff. Another article outlined providing trial participants with “transparent, comprehensible trial information, data and results” as one of the four pillars of patient-centricity. And it genuinely adds value: tailoring the consent process better to the needs of individual patients can improve trial engagement and compliance.
A more patient-centric informed consent process starts with better understanding each participant by assessing their ability to understand trial information. While a doctor is well-equipped to make this assessment, without a suite of options to tailor the consent process to the individual, this step alone will not suffice. Longer consultation times may help, but only when the information is delivered to the participant in a comprehensible way.
To truly achieve patient-centric informed consent, materials need to be simplified and adaptable to everyone. Many of today’s patients are more informed, engaged, connected, and likely to take control of their healthcare.
Meeting the needs of all participants to achieve truly informed patient consent requires information innovation, and harnessing interactive digital and audio-visual platforms fully explaining clinical trials, and participant’s roles in them.
For more information, visit advarra.com.