Informed consent means that a doctor must fully inform you about a medical treatment and obtain your approval. If this does not happen, the doctor may be held legally responsible.
What does informed consent entail?
Informed consent refers to the conscious agreement of a patient with a medical procedure. A doctor is required to:
- Inform you about the intended treatment
- Explain possible alternatives
- Discuss risks and side effects
- Request your explicit consent
Obligations of the doctor
The doctor must inform you in detail about the following aspects:
| Subject | Explanation |
|---|---|
| Type of treatment | What the procedure exactly entails |
| Objective | What is hoped to be achieved |
| Risks | Chance of complications or side effects |
| Alternative options | Other possible treatments |
| Consequences of not treating | What can happen without intervention |
When is a doctor liable?
If informed consent is absent and a risk materialises, a doctor may be liable if:
- You were not informed of the risk that occurred
- You would have made a different choice if aware of this risk
- The resulting damage is directly related to the undisclosed risk
Burden of proof
The proof of informed consent lies with the doctor:
- A signed consent form serves as proof
- Notes in the medical record can support this
- In the absence thereof, the doctor must demonstrate that information was provided
Exceptional situations
In some cases, informed consent is not required:
- In emergency situations (for example, if the patient is unconscious)
- If the patient indicates they do not wish to receive information
- If providing information would cause serious harm (therapeutic exception)
I signed a form, but did not understand the risks. Is this valid consent?
It is not just about the signature, but whether you truly understood the information. The doctor must verify that the explanation was clear to you.Which risks must a doctor mention?
All risks that could influence your decision, including rare but serious complications. Guidelines per medical specialty specify this further.Can I file a claim if the treatment went well, but I was not informed?
Without damage, there is no basis for a claim. You can file a complaint with the healthcare institution. Compensation requires that an undisclosed risk has materialised.Frequently asked questions
Is a signature always required for informed consent?
No, a signature is not mandatory, but it serves as strong proof. The doctor must be able to demonstrate that you were properly informed and consented voluntarily, for example via record notes or oral agreement.
What to do if I think I was insufficiently informed?
Check your medical record for relevant notes. In the absence of proof of informed consent, you can file a complaint with the healthcare provider or complaints committee. In case of damage from an undisclosed risk, you can consider legal action via a medical law attorney.
Does this also apply to simple procedures, such as blood draws?
Yes, informed consent is required for every medical intervention. The doctor must explain why the intervention is necessary and what risks are involved, even for routine procedures. You may always ask additional questions or refuse.
Can I withdraw my consent later?
Yes, you can withdraw your consent at any time, even during a treatment. This must be clearly and timely communicated to the doctor. The treatment will then be stopped, unless this immediately endangers your well-being.
What if a 'very rare' risk occurs anyway?
The doctor must discuss all relevant risks, including rare but serious ones. If an undisclosed risk materialises, the doctor may be liable. The court assesses whether you would have decided differently if aware of this risk.
How do I know if I was sufficiently informed?
Ask yourself: would I have chosen this treatment if I knew all the risks and alternatives? If you are in doubt, discuss it with your doctor or seek legal advice.
Relevant institutions in Leiden:
- District Court of The Hague, Leiden Location: For legal disputes over medical liability.
- Juridisch Loket Leiden: Stationsweg 46, for free legal advice on informed consent and other healthcare issues.