The 4 Criteria of Truly Informed Consent for Patients

Posted by Jim Lane on Nov 24, 2017 1:22:42 PM


terms and conditions.png'I have read and agree to the terms and conditions’ – even in the era of “fake news’ this still must be the biggest lie on the internet! One journalist’s experiment concluded that if we were to read fully all the legal agreements we are faced with it would take up to 8 hours per week! So what do we do? We click the checkbox and hope there’s nothing too nasty in the small print.

The truth is that we have become conditioned in recent years to ignore the implications of providing our consent and to skirting past the tedious detail.

Which probably explains why informed consent for patients is one of the most challenging and complex legal and ethical aspects of a clinical trial. The 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:

  1. Information disclosure
  2. Competence
  3. Comprehension
  4. Voluntariness

There are numerous challenges associated with this considering the informed consent document is likely to be at least 15 pages long and also that today’s trial protocols are more complex than ever. Now we have stratified, multi-arm and adaptive trial designs, novel types of treatments, and parallel translational studies. On top of this, potential trial patients vary enormously in terms of their sociocultural diversity, levels of literacy, and physical and mental capacity.


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Are we genuinely achieving informed consent?

In a survey of nearly 300 cancer trial participants, around 90% said they were satisfied with the consent process and most patients 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 that they were not certain to benefit from the treatment themselves, and 70% of participants did not recognize the unproven nature of the treatment.

This study, conducted in US cancer centers, probably only scratches the surface. Achieving full understanding of a trial protocol can be even more be challenging in developing countries, where participants may be less educated), may have literacy problems, be unfamiliar with medical research, and have different cultural views on disease.

Another study that looked into 103 clinical trials found that while up to 75% of participants were identified as fully understanding that the consent process provided them freedom to withdraw at any time, only 54% of participants in one sample could recall at least one risk of the trial, while only 53% were identified as “understanding of placebo”.
In these cases, it is even more important that consent forms are clear and accessible to a broad and uneducated audience.

Yet, although recommendations have been made to simplify trial consent forms towards a reading age of 12 to 14 years, in practice, this is not happening often enough.

Even with exemplary patient information, the competency of the potential patient at the time of their consultation is a further barrier to informed consent. Age, mental and physical health, and the current stage of their disease can all affect the patient’s ability to make a rational, autonomous decision.


What can be done to achieve informed consent?

Ideally, the informed consent process should mark the beginning of an ongoing engagement between the patient and clinical site staff. In a recent article, providing trial participants with “transparent, comprehensible trial information, data and results” was cited as one of the four pillars of patent-centricity. And it can genuinely add 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 a better understanding of each patient, and an assessment of their ability to understand information about the trial. The patient’s doctor will be well-equipped to make this assessment, but without a suite of options to be able 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 patient in a comprehensible way.

To truly achieve patient-centric informed consent, materials not only need to be simplified, but be adaptable to the different patients who walk into the clinic. Many of today’s patients are more informed, engaged, and connected, and likely to take control of their healthcare. But not every patient will be this way.

Meeting the needs of all patients to achieve truly informed patient consent will require innovation in information, and the harnessing of digital, interactive and audio-visual platforms that fully explain what clinical trials are, and the role of participants in them.

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Topics: patient engagement

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