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Without explanation, even if there is a consent form, it is meaningless

The term "informed consent" is a concept that was originally developed through US court cases and is not used in Japanese court cases; the corresponding legal term is "duty to explain." The history of the term is explained in detail in "Basic Knowledge of Medical Ethics, 2018 Edition"1.

When I first began studying law, I learned the term "duty to explain." It felt strange, as I had never heard the term before, at least in my medical education. As I continued to learn, I learned that in the medical field, it is treated as "informed consent." Legally, it is not just a general rule, but an obligation to explain the information necessary for the patient to make a decision. Because it is an obligation, judges consider it a must. To this day, I believe that the difference in terminology for the same phenomenon clearly reflects the points each side places importance on, and that this discrepancy is one of the factors that lead to disputes.

While I understand that some may disagree, to simplify things for understanding, in the medical field, "consent," or obtaining consent, or more simply, signing a consent form, is emphasized, while in court, the emphasis is on "explanation." Of course, signing a consent form is important. However, legally valid consent is consent to what has been explained, so consent cannot be said to have been given to anything not included in the explanation. In most cases, treatment goes well as planned, so the details of the explanation do not pose legal issues. However, if an unexpected adverse outcome occurs and legal issues arise, the consent form will be meaningless for details that were not explained.

Conversely, even without a signed document, the mere recording of the explanation and subsequent consent is sufficient proof of consent. In the medical field, a lot of explanations and subsequent consent must be obtained, so having a standard written document reduces omissions and is more efficient. I'm not denying this, but I feel there is a misunderstanding that the existence of a written document is important.
A common pattern in lawsuits over the duty to provide information is that when a patient experiences a negative outcome for which they were not given prior explanation, the patient claims that they would not have received the treatment if they had been given an explanation, and even if you check the information documents and consent forms, it is overwhelmingly clear that there are no descriptions of any disadvantages that match what actually occurred. In response, the doctor claims that they did provide an explanation, and the two parties' claims are at odds.

Explanations that patients cannot understand are insufficient

For example, in cases where an adverse event occurred during invasive treatment, resulting in serious after-effects such as hypoxic encephalopathy, when examining the explanatory documents provided by doctors who claim to have provided an explanation, it is often the case that the relevant part of the complication is simply described as "neurological disorder."

How many patients would respond in court that if they were only told this explanatory document was read aloud, they would likely not regain consciousness due to hypoxic encephalopathy and become bedridden? It's clear from your own experience that humans generally have a hard time remembering things they don't understand. It's best to think of judges as representatives of the general public, and if judges can't understand an explanatory document after reading it, they tend to judge it as insufficient. Current judicial practice, not just in the medical field, is that even if an expert uses technical terms incomprehensible to non-experts, they cannot be said to have fulfilled their duty to explain.

However, in medicine, it is not acceptable to leave an illness untreated just because the patient does not understand, so this is not something that can be easily made into a rule. In fact, many doctors who are criticized by patients for not explaining things say that if they emphasized serious complications too much, the patient would be afraid of treatment and a valuable opportunity for treatment would be missed, or that because they themselves or their facility have never experienced the complications that are problematic in the treatment in question, they did not think it was necessary to give an explanation that would have a negative effect on the patient's decision-making.
　
Will a judge be willing to excuse you from liability with this explanation? Unfortunately, the answer is no. In the second part, we will explain the factors that a judge will consider when determining the explanation required in cases where serious complications have occurred.

1. Basic Knowledge of Medical Ethics 2018 Edition [Doctors and Patients] B-2. The Birth and Growth of Informed Consent
https://www.med.or.jp/doctor/rinri/i_rinri/b02.html