Before a doctor provides medical treatment, the patient must be well informed about what will happen, what risks are involved, and what alternatives exist. That is called informed consent.

Without proper information, a patient cannot give informed consent. In this blog we explain what informed consent entails, when consent is valid and when it is not, and what you can do if you have been insufficiently informed.

What is informed consent?
The guiding principle in medicine is that patients decide for themselves about their treatment. For that, it is essential that the patient understands what the treatment involves, what risks are associated with it, and what alternatives exist.Informed consent therefore means: consent based on complete and understandable information

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What falls under ‘treatment’?

In this context, ‘treatment’ basically refers to everything a doctor does for you within your care pathway. This goes beyond just the actual procedure or operation. Think, for example, of physical examination, diagnostic tests, making a diagnosis, and the aftercare that follows. In short: every medical action that is part of your treatment falls under this.

• The doctor must explain:

• The nature and purpose of the treatment;

• The possible risks and complications;

• The likelihood of success or recovery;

• Alternatives, including watchful waiting or not treating;

The consequences of refusing the treatment.

Information about effectiveness and waiting timesIn addition to the basic information about the treatment, the doctor is also obligated to be honest about the proven effectiveness of the proposed care. This means you may expect the doctor to state whether a treatment is scientifically substantiated or, conversely, has not (yet) been sufficiently proven. Especially with new treatment methods, alternative therapies, or experimental care, it is important that you receive clarity about this.You should also be informed about any waiting times for the treatment. This way you know what to expect and can take this into account in your decision whether or not to consent to the proposed treatment.

• In summary:
• Does a treatment have a proven effect? The doctor must state this explicitly.

How long will it take before you are helped? You should also be given clarity about that.

All this ensures that, as a patient, you get an honest and complete picture, so that your consent is truly ‘informed’.

Only when this information has been provided and understood can consent be legally valid.

Implicit and explicit consent: when does what apply?Consent for a medical treatment can be given in different ways. In many cases, verbal or even tacit (implicit) consent is sufficient. For example: if you extend your arm for a vaccination, the doctor may assume that you agree to the injection. Also for simple or urgent procedures, such as stitching a wound after an accident, implicit consent is often considered sufficient.However, if it concerns an invasive, higher-risk, or non-urgent (elective) treatment, you as a patient must give express (explicit) consent. In that case, the doctor will not only provide all relevant information but also record in the medical file that you have agreed.

• In short:Implicit consent:
•  for simple, routine, or necessary emergency treatments.Explicit consent:

 for major, high-risk, or planned medical procedures, always confirmed in writing or orally and documented by the physician.When may a physician treat without explicit consent?A physician may only start treatment once the patient has given consent. However, that consent does not always need to be expressly stated. In practice, it often happens that for simple, routine procedures or in emergency situations a patient gives implicit consent—for example, by extending an arm for an injection or by getting onto the treatment table.For invasive treatments, high-risk procedures, or planned surgeries, the situation is different. It is then required that the patient clearly—i.e., explicitly—consents to the proposed plan. This explicit consent is carefully documented by the physician in the medical record.

This ensures that the patient retains full control over important decisions and that the right to self-determination remains central.

Why good communication and informed consent are so importantGood communication between physician and patient goes beyond a legal obligation; it forms the basis for a strong relationship of trust. By speaking clearly and openly about the treatment, risk factors, and options, the patient feels taken seriously and involved in what is happening to him or her. This trust not only makes patients more likely to share their concerns or doubts, but also promotes adherence: people are more inclined to follow advice when they understand why certain choices are being made.

With clear explanations and sincere attention, not only are the rules met, but mutual respect also develops—a foundation for good care.

From the classic model to shared decision-makingWith the introduction of additional rules around informed consent, the emphasis is increasingly shifting to so-called shared decision making, or ‘shared decision making’. Whereas in the past the doctor often decided what seemed best—and the patient followed that advice—today the patient’s preference is central.In shared decision making, doctor and patient discuss the treatment together. You indicate what is important to you—for example, work, family, or quality of life—and the doctor explains the medical options, including the pros and cons. This way, you make a decision together that fits your personal situation and values, rather than simply following the doctor’s advice.

This approach ensures that medical choices are not only medically sound, but also align with the patient’s wishes and expectations.

Legal basis of informed consent

The right to information and consent is laid down in Article 7:448 of the Dutch Civil Code. It states that the healthcare provider must inform the patient “clearly” about the proposed treatment and the expected consequences or risks.
In addition, the law requires the doctor to keep a proper medical record in which this information is documented.Read more about this in our blog Medical record: access, copy and correction

.Other statutory information obligationsIn addition to the Civil Code there are also other laws that contain information obligations for the physician, such as the Healthcare Quality, Complaints and Disputes Act (Wkkgz). According to this law, the healthcare provider (often the treating physician) must, if the patient requests it, inform the patient about the care offered. This concerns not only the nature of the care, but also the fees, the quality, and the experiences of other patients with that care.

Moreover, the physician is obliged to inform the patient about whether or not the care has scientifically proven effectiveness and any waiting time. This gives the patient a complete picture and allows him or her to make an informed decision.

Latest additions to the information obligation since 2020Since 1 January 2020, the information obligation for healthcare providers has been further expanded. Not only must doctors and other care providers inform patients in a timely manner about the treatment and the risks, it is now also legally required to consult with the patient about the proposed treatment. In doing so, the patient must be actively invited to ask questions.

• In addition, the healthcare provider must provide additional information, such as:
• The option to decline the treatment.
• Alternative examinations or treatments that can be performed by other healthcare providers.

The expected duration and when the treatment can begin.

These changes are intended to give the patient more influence and say—that is, to make decisions about care together. In other words, the emphasis shifts from the traditional ‘the doctor advises’ to ‘deciding together,’ with the patient’s wishes and preferences at the center.

When is consent not legally valid?

• Consent is not legally valid if the patient has not been informed, or has been informed incorrectly. This can occur in various ways, for example:

• The doctor did not explain which risks are associated with the treatment;

• Alternative treatments were not discussed;

• The likelihood of complications has been downplayed;

• The patient was pressured to consent;

Consent was given without the information being understandable.When a doctor has breached their duty to inform, the treatment can be considered unlawful. If the patient suffers harm as a result, there may be medical liability. You can read more about this in our blog Medical liability in the Netherlands: patients’ rights and the path to compensation

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The importance of evidence: what is in your medical record?In a liability case, the medical record

crucial. It must state what information was provided, whether an informed consent form was signed, and whether there are notes of conversations with the doctor.Recording consent: explicit and implicit

A doctor may only start a treatment after the patient has given consent. This consent can be given in various ways. Sometimes there is implicit or tacit consent—for example, for less invasive procedures or when immediate action is required in an emergency. However, if it concerns an invasive, risky, or planned (elective) treatment, you as the patient must give explicit consent. In such a case, this consent is also documented by the doctor in the record.
If this information is missing, the burden of proof often falls more heavily on the healthcare provider.You can request the record from the hospital or the treating provider. How you do that is explained step by step in our blog Medical record: access, copy and correction

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Consequences of violating informed consent

If it turns out that you were not properly informed, the doctor or the hospital may be liable for the damage resulting from that. For example, this may be because, with the correct information, you would not have consented to the treatment, or because you would have chosen an alternative with less risk.In such a case, a compensation

• can be claimed, consisting of:Material damage

• – medical expenses, loss of income, travel expenses, household help;Non-material damage (pain and suffering)

– compensation for pain, sorrow, and loss of enjoyment of life.Read in our blog How can you calculate pain and suffering compensation?

how the amount of pain and suffering compensation is determined.

• Common misconceptions

• A signature on a consent form does not automatically mean that informed consent has been given.

• An oral explanation is also required — written information alone is not enough.

• The fact that a risk is listed in a leaflet does not relieve the physician of the duty to discuss it personally.

Not every complication is an error; there must be a breach of the duty to inform and demonstrable harm.

Practical example

A patient received only a standard leaflet with general risks prior to surgery. During the procedure, a complication arose that was not listed in the leaflet and had not been discussed. The patient asserted that, with proper information, he would not have consented to the surgery. The court ruled that the hospital had breached its duty to inform and awarded damages.

1. What can you do if you think you were not properly informed?

2. Request your medical record.

3. Note what was said during conversations with doctors.

4. Contact a specialized personal injury lawyer.

Have it assessed whether the duty to inform has been breached.

Our lawyers help you safeguard your rights and take the right steps toward compensation.

Why Arslan Advocaten?At Arslan Advocaten

we regularly handle cases in which the duty to inform has been breached. We work with independent medical advisors and ensure that your file is complete. Our services are free of charge for victims, because we recover the costs from the liable party.