The right to information and informed consent

Only those who are well informed can make a competent decision in cooperation with the doctor as to how an illness should be treated. Legislators have therefore anchored the patient right to information in the German Civil Code. According to this, patients have the right to receive all key information about their diagnosis, the outlook and the treatment of their illness.

Doctors must inform their patients about the following aspects:

• The diagnosis
• The expected health development
• The treatment (procedure, benefits and risks) and the measures required during or after this
• The expected cost of the treatment if this is not covered by the health insurance provider, for example in the case of individual health services (IGeL)

The doctor should also explain what you can do yourself so as not to endanger the success of the treatment. For example, this could be telling you not to drink alcohol with certain medication.

When due to have an operation or other medical intervention, patients’ doctors must provide them with details of the intervention, the procedure and the risks. They must also explain the consequences of not performing the suggested intervention.

If there are various treatment options, the alternatives must also be explained. This particularly applies if these are associated with different risks and chances of recovery.

Patients only decide whether or not to accept the medical intervention, for example an operation, after this consultation. This is therefore known as a preoperative or informed consent consultation.

Who performs the informed consent consultation?

The consultation must be provided by the patient’s doctor or another professional who is qualified to perform such a treatment. A nurse, for example, is not permitted to provide the consultation on the doctor’s behalf. It is also not sufficient for the doctor’s practice to simply offer you information sheets or brochures.

This should ensure that you can ask questions and receive information from someone with the necessary specialist expertise. If there is anything that you have not understood, please ask the doctor to explain it in another way.

How does the consultation work for people who speak little German?

Even if patients speak no or little German, doctors must ensure that they understand the explanations. If doctors are not sure this is the case, they must involve an interpreter or someone who is proficient in the patient’s language. This can be a nurse or one of the patient’s family members, for example.

If there is any doubt as to whether the lay interpreter is able to interpret the information properly, the doctor must insist that a professional interpreter is involved. The patient is liable for the interpreter’s costs.

When does the informed consent consultation occur?

When the consultation occurs depends on the severity of the intervention. It must be scheduled to offer you enough time to weigh up the pros and cons and make your decision. In the case of an injection, for example, it suffices for a doctor to explain about it immediately beforehand. In the case of a planned knee operation, on the other hand, the informed consent consultation should occur the day before the operation at the latest.

If you decide to go ahead with the intervention, you usually confirm your consent by signing the informed consent form, of which you will receive a copy. Patients also have the right to expressly waive the informed consent process. If you wish to do this, the doctor will probably ask you to confirm this in writing.

Doctors must not simply have patients sign the informed consent form without verbally explaining all aspects of the intervention to them. In the event of repeated investigations or treatments for which informed consent consultations have already taken place, however, reference can be made to these. 

In medical emergencies, an informed consent consultation is not required. This means, for example, that if an accident has left a patient unconscious, doctors will provide first aid without the informed consent. In such cases, it is assumed that the patient would wish such interventions to be made. If the patient has an advance healthcare directive (Patientenverfügung), this must be observed.

However, there are also situations in which patients are generally unable to make their own decisions in relation to treatment, for example if they have dementia. If an operation is proposed, a representative must make the decision for them.

In such cases, the informed consent consultation takes place with the representative. A representative can be someone who has been named in the lasting power of attorney for health and welfare (Vorsorgevollmacht) or a legal guardian. In the event of an advance healthcare directive that authorizes or prohibits the planned treatment, this must be observed.

Do the risks of an operation also have to be explained to children and adolescents?

In the case of children and adolescents under the age of 14, the parents generally have to authorize the operation and the informed consent consultation must therefore take place with them. Once adolescents have reached mental maturity and developed sufficient cognitive faculties and decision-making abilities to understand the planned processes and impact of the intervention, they should be given age-appropriate explanations.

If you are in any doubt about a diagnosis or the proposed treatment, you should initially ask for time to think. You can use this time to obtain further information.

For certain interventions that can be planned, patients have the right to a qualified second opinion procedure. In such cases, the doctor who has recommended the intervention must inform you about the right to a second opinion and provide you with a free copy of the findings and examination results if you would like one. This also includes all documents relating to diagnostic procedures, such as CT, MRI and x-ray images. The health insurance provider assumes the costs of the qualified second opinion.

When making a decision, it can be useful to consider the following aspects:

• What do I hope the treatment will achieve? What is important to me personally?
• What are the pros of the treatment?
• What are the cons?
• What other options are available?
• What happens if I don’t do anything?

Ultimately, it is up to you whether you want to undergo a diagnostic procedure, treatment or operation. Even if a doctor regards a treatment as medically essential, you can still decline it.

Do you feel like your doctor has provided you with insufficient or incorrect information prior to an intervention or not explained things at all? Then speak to your doctor about this. This makes it possible to quickly clear up potential misunderstandings.

In the event of doubt, you can also request a further appointment after the informed consent consultation to discuss your questions with the doctor or have the treatment explained again. It can be helpful to have someone you trust accompany you to the appointment as it is easier to remember information when there are two of you. However, the doctor must agree to a second person being present.

If following a personal consultation with the doctor, you still believe that the duty to explain has not been fulfilled, you can send a written complaint to the Chamber of Physicians.

The Chamber of Physicians is the supervisory authority for doctors and sanctions breaches of professional obligations. The State Chamber of Physicians where the practice or hospital is located is responsible for the complaint. If the Chamber of Physicians determines that there has been a breach of professional obligation, it can sanction this, for example with a financial penalty.

The contact addresses of the State Chambers of Physicians can be found on the German Medical Association website.

When am I entitled to compensation?

If your doctor has not provided you with sufficient information prior to an operation, you can sometimes be entitled to compensation. This is the case if you would not have consented to an operation if you had been correctly informed about it. After all, consent is only valid if it is provided following a proper informed consent process.

If legal proceedings are required, the doctor must prove that the informed consent process took place correctly prior to the operation or that you would have still decided to have the operation had a proper informed consent process occurred. If the doctor is unable to do this, you will be entitled to compensation.

If you are considering taking legal action, you should take advice on the procedures, costs and chances of success of legal proceedings in advance. Our overview on the topic of complaints provides information about which advice centers you can contact to this end.

In the event of any legal uncertainties or individual questions in relation to the medical duty to inform and explain, the Independent Patient Advice Service for Germany (UPD) is a source of useful advice and support.

You can also obtain advice on this topic from several regional consumer advice centers.