What Is Informed Consent?

In short

Informed consent is an understandable account of the risks and of the options. The signature alone is not consent. An intervention without information is in a separate article.

The date of the form, the language and who signed are read.

The dispute on an aesthetic promise is in a separate cluster.

The institution's archive is opened with a request for the patient file.

Related articles: the patient file.

Informed consent is the patient giving consent with a free will, having understood the medical intervention sufficiently. The signature on the form may not always be counted as sufficient by itself. The content of the information, its understandability and its record are important. This article is general information.

In the health service, trust starts with understandable information. The patient should not sign without knowing what will happen; the physician and the institution should not hide the risks either. A hurried signature can turn later into the debate it was not explained, or it was explained.

From the point of view of health law, consent is both an ethical and a legal ground. Although it is thought of apart from claims of a fault of application, in practice it often intersects with files of medical malpractice.

What does informed consent mean?

Consent is the joining of information and of consent. Not only the signature I accept, but the conveying of sufficient information about what the intervention is, is expected. The account should be made in plain language suited to the patient's age, to the level of education and to the risk profile of the intervention.

The typical headings of information:

• The aim and the method of the intervention
• The expected benefits
• The known risks and the possible complications
• The alternative methods
• The results that can appear if the intervention is not done
• The possibility of an answer to questions

In aesthetic and elective procedures, the explaining of the expected appearance and of the realistic limits matters separately. The dimension of consumer law can come onto the agenda in some disputes of a private health service; it is not applied automatically in every file.

The sufficiency of the information is not an abstract slogan. The questions the patient asked, the relevance of the risks that were explained to the intervention, whether the alternatives were really offered, and whether the signature was taken under the pressure of time, are looked at together. A form held out five minutes before entering the operating room does not make the debate on proof easier.

In procedures in which there is more than one physician, or a team, where the responsibility for the information concentrates can also be debated. Anaesthesia, surgery and additional interventions can carry separate packages of risk. If it is not clear in the records which information was given by whom, the proof scatters in the dispute. The internal protocol of the institution and the design of the form therefore gain importance in practice.

Whom does it concern?

• Patients who will have a surgical or an interventional procedure
• The parties of an aesthetic or a medical procedure
• The legal representatives, where the person is a minor or the power of discernment is debated
• The physicians and the health institutions that conduct the consent process
• The parties of a dispute who carry a claim of incomplete information

The subject of consent is not only the form before the surgery. Diagnostic interventions, anaesthesia, the use of a blood product and additional interventions can also widen the scope of the information.

How does the process work?

1. The planning of the intervention. The indication and the options become clear.
2. The information. The risk, the benefit and the alternatives are conveyed in an understandable language.
3. The answering of the questions. The points the patient did not understand are clarified.
4. The taking of the consent, and the record. The written form, and additional notes if there are any, are drawn up.
5. The intervention, and additional information if necessary. If the scope changes, a need for a new consent can be born.
6. The examination of the records in a dispute. The form, the time stamp and the testimony are assessed together.

Rights, conditions and periods

The patient's right to be informed and to consent has a frame in the physician's professional duty of explanation. In emergencies special conditions can come onto the agenda. The taking back of the consent can give birth to different results according to the stage of the intervention.

As regards proof, the discipline of the record becomes determinative more often than the period. The loss of the form, an undated signature or general printed texts can weaken the proof. When a dispute arises, the periods of limitation work according to the choice of the separate path; gathering the documents early is still important.

The debate on consent often runs in the same file as a claim of medical malpractice. In this case the court or the expert can look both at the sufficiency of the information and at the standard of application. Confusing the two headings clouds the defence or the request. Clear sentences of the claim should be built: is it incomplete information, a faulty application, or both together?

In emergencies the standard of information may not be expected at the same intensity as in elective procedures; the existence of the urgency should be made concrete, however. Saying it was urgent is not enough. The clinical picture, the pressure of time and the necessity of the procedure that was done should be readable from the records.

Mistakes often made

• A signature without reading, or without an explanation
• Being content with medical jargon that cannot be understood
• Not explaining the alternatives at all
• Creating a perception of a guaranteed result
• Losing the form, or filling it incompletely
• Not thinking of an additional consent when the scope changes
• Thinking consent is entirely the same as malpractice
• Being content only with a general list of complications, and skipping the risks peculiar to the patient
• Keeping the promises in the messaging and in the images apart from the form

Important information: keeping the records is critical for proof. The existence of a signature does not always end the debate on the sufficiency of the information.

In the aesthetic field in particular, shares on social media, before-and-after promises and accounts of a price package can become part of the actual environment of information. If what is written on the form and what is said in the sales meeting contradict, the dispute grows. The institutions' language of communication and the text of the consent should therefore be consistent.

Related legislation, in general

The rights of the patient, the health legislation and the general principles of the law of liability are assessed together. Internal procedures make the application easier; they do not by themselves guarantee the legal result, however. The current regulations should be taken into account.

In judicial practice the sufficiency of the information, and its proof, are often debated. The result depends on the character of the intervention, on the risk profile and on the concrete records.

A reading of the legislation does not give the result that if there is a form the problem ended. The obligation of a form, or the custom, does not mean the content is understandable and sufficient. The current practice and the concrete event should be read together.

Additional points of assessment in practice

The mistake most often seen in the debate on informed consent is the assumption that if there is a signature everything is complete. The signature can form a presumption that the information was given, but the sufficiency and the understandability of the content are a separate question. An account in the patient's mother tongue, the possibility of asking a question and the pressure of time are part of this question.

In elective procedures there is a wider time for the information; in urgent procedures the clinical necessity comes to the front. This separation does not legitimise sticking the label urgent arbitrarily. The claim of urgency should be readable from the records. Otherwise the debate on the deficiency of consent grows.

In aesthetic and medical procedures the sales meeting, the price package and the promises on social media shape the actual environment of information. If cautious language is used on the form and exaggerated language is used in the meeting, a contradiction is born. For the institutions, consistent communication is a practical discipline that reduces the risk of a dispute.

Consent and malpractice are not the same thing. A claim of a deficiency of information can be built apart from a claim of a fault of application. In files where the two are put forward together, the sentences of the request and of the defence should be separated clearly. Otherwise the examination of the expert and of the court scatters.

The policy of keeping the records should be built before the procedure, not after the dispute arises. If the form, the additional account of the risk, the image and the correspondence are archived as a whole, the proof strengthens. This does not mean the result will become final in favour; it only prepares the healthy ground of the assessment.

Understandability, time and proof

The legal value of the information is closely related to whether it was made in a language the patient can understand. A form filled with technical jargon may not be understandable even if it is long. The duration of the account, its setting and the possibility of questions and answers are part of the debate on sufficiency.

A signature taken under the pressure of time is a frequent subject of criticism, especially in elective procedures. A form held out without the patient being given the opportunity to read and to ask can weaken, later, the defence I was informed. This does not mean every signature is invalid; it means it enlarges the debate on proof.

When a need for an additional intervention is born, the scope can change. It should not be assumed that the first consent covers every additional procedure automatically. If there is no clinical necessity, a need for additional information and for a new consent can be born. It is important that this passage is visible in the records.

In consents taken with a legal representative, the authority of representation and the patient's power of discernment are looked at separately. If these areas are left incomplete, both the debate on consent and the debate on proof grow. The institution's protocols covering these details is a practical precaution.

Institutional practice and the patient's expectation

In health institutions the consent process is often shortened to having the form signed. Good practice, however, builds the account, the question, the record and the archive together. The training of the staff, the design of the form and the management of time are part of this process. An incomplete protocol can leave even one physician's well-intentioned account weak in the proof.

The gap between the patient's expectation and the medical reality grows especially in aesthetic and elective procedures. Not creating a perception that it will definitely be corrected is a point of attention both ethically and legally. The expected benefit and the possible limits should be spoken in the same meeting. The record of this conversation reduces, later, the debate you did not say so.

A claim of a deficiency of consent does not mean automatic compensation. The harm, the causal link and the character of the intervention are looked at together. Incomplete information can still affect the assessment of liability. Preventive discipline is therefore cheaper than the defence after the dispute arises. The text is general information; it does not offer a guaranteed result.

A short checklist

Before the intervention these questions are useful: was the aim and the method explained? Are the risks in an understandable language? Were the alternatives spoken? Were the questions answered? Were the form and the additional records archived? This list does not finish every file; it makes the discipline of information visible, however. If there is an incomplete answer, completing it before the procedure is more functional than the defence after the dispute. If there is no urgent clinical necessity, an understandable account should be preferred in place of a hurried signature. This approach is not a guarantee of a result; it is a preventive frame.

The trust between the patient and the physician is built with the sincerity and the understandability of the account, and not with the length of the consent form. The form is the tool of proof of this account. If there is no account, the form can stay weak by itself. Protecting this separation is valuable both as regards the rights of the patient and as regards professional safety.

The elements of consent, and the emergency

Informed consent is read in practice in three layers: information, understanding and free consent. The information covers the aim of the intervention, its method, its expected benefits, its known risks, its alternatives and the results that can appear if it is not done. Understanding requires an account suited to the patient's language, and the possibility of asking a question. Free consent is a declaration of will far from pressure or from misleading. If one of these three is missing, the signature on the form may not end the debate by itself.

In elective procedures the elements can be built within a wider time. In an emergency the clinical necessity comes to the front; the intensity of the information may not be expected to be the same as in an elective procedure. The label urgent cannot be stuck arbitrarily, however. The urgency should be made concrete from the records, with the clinical picture, the pressure of time and the necessity of the procedure. Otherwise the debate on the deficiency of consent grows.

A change of scope is a separate element. It should not be assumed that the first consent covers every additional intervention automatically. If there is no clinical necessity, a need for additional information and for a new consent can be born. The elements of consent and the claim of fault in medical malpractice should be built in separate sentences.

Where the consent document is read from

The consent document, the account of the risk and the patient file are read side by side. An amount is not written. The office being in Çankaya does not choose the competent authority. The signed form is not put in the place of the petition and of the decision.

Conclusion

Informed consent is the common ground of trust and of conformity with the law. Although the signature on the form is important, the content and the understandability are the essence. This article is for information; each event is assessed according to its own conditions. It does not contain a promise of a definite legal result.

For a wider frame you can look at health law, and for the separation of fault and complication at the article what is medical malpractice?.