In short
An intervention without information is a debate on consent; not every complication is an absence of consent.
It is a debate on consent. Not every complication is an absence of consent.
It is in the article on informed consent.
The language of the form and the moment of the signature are read.
Related articles: informed consent.
The right to an informed decision is born before the intervention
Consenting to a medical intervention is not only saying yes, or signing a paper. The patient needs to be able to decide by understanding what will be done, the basic aim of the intervention, its important risks, the reasonable options and the possible results of the procedure not being done. If it is thought that the information was not given, the first step is to form the record of the event and of the documents without disrupting medical safety. If there is a continuing need for treatment, the care should not be postponed because of a legal concern.
The patient can write, as far as they remember, when, by whom and which information was given to them. The duration of the meeting before the intervention, where the signature was taken, whether there was an opportunity to ask a question, and the risk learned later, can be noted separately. These personal notes do not take the place of the official document; they determine the concrete points that will be compared with the consent form in the file and with the clinical records, however.
This text is general legal information. Because the urgency of each intervention, its scope and the patient's capacity to decide are different, a result peculiar to the person cannot be drawn.
Information, consent and the intervention are three separate stages
Information is the giving to the patient of the information necessary for the decision. Consent is the will to accept or to refuse the intervention in the light of this information. The intervention is the health worker's medical application. Although these stages are connected, they do not take each other's place. A signature taken without the information being given can give birth to a debate on an informed will in the real sense. Valid consent having been taken also does not remove the duty that the intervention be done carefully from the technical point of view.
In the legal examination these questions should be separated from each other:
- Which procedure was suggested to the patient, and how was the aim explained?
- Were the important risks and the alternatives explained?
- Was the patient in a position to understand the information, and did the patient have enough time for the decision?
- Was the consent given with a free will?
- Did the intervention that was done stay within the limit of the intervention that was accepted?
- Did the harm that appeared arise from the technical application, or from the risk that was not explained?
This separation prevents the two extreme approaches that the form exists, the subject closed, or the information was missing, there is necessarily a medical error. The basic concepts of the subject are explained more widely in the content what is informed consent?.
Which information is meaningful for the decision?
The scope of the information is not to turn the patient into a person who has received a medical education. The aim is to provide the information with which the person can make a reasonable decision about their own body and life. The character of the intervention, the expected benefit, the important risks with a frequent or a serious result, the alternative treatments, the possible effects of refusing the treatment and the healing process are the basic headings. If there are risks peculiar to the patient, they may need to be explained apart from the general form.
For a person who uses their voice in their profession, for example, a risk that can give birth to an effect on the voice can be more determinative as regards the decision than for another patient. In a patient who uses a medicine that increases the risk of bleeding, or who has a certain allergy, it is also expected that the personal position is reflected in the planning. The content of the information is assessed according to the concrete patient's reasonable need for information, not only according to the general list of risks of the procedure.
The weight of the risks can matter as much as their probability. A risk of a very low probability but of a serious result can enter the scope of the explanation if it is of a character that can affect the patient's decision. An unlimited and incomprehensible list of risks does not provide real communication either. The technical terms need to be simplified, and the patient's questions need to be answered.
How is the legal value of the signed form examined?
The consent form is one of the important pieces of evidence of the information process. The value of the form depends on its heading, its content and the conditions in which it was taken, however. A text that carries the general expression I accept every kind of procedure, in place of the name of the intervention, can show limited information as regards the concrete risks. Explanations added by hand, the date and the hour, the health worker who explained the form and the patient's questions can strengthen the context of the document.
These points can be checked on the form:
- Is the intervention defined correctly and openly?
- Are the important risks and the alternatives made concrete?
- Are there the dated signatures of the patient and of the health worker?
- Was the signature taken while there was a possibility of deciding calmly?
- Was a language, or a method of communication, the patient would understand used?
- Is there an additional explanation or consent for a procedure that widened later?
If it is claimed that the signature was taken at the door of the operating room, under intense pain or under the effect of sedation, the time records gain importance. If it is recorded that the patient received the form days before and that the questions were answered, the assessment can be different. The whole of the process is examined, in place of a single element.
The exception of the emergency is not unlimited
In a real emergency in which the patient's consciousness is closed, a representative cannot be reached and the delay gives birth to a risk to life or to serious health, the inability to take consent beforehand for the necessary intervention is assessed differently. The aim of this exception is to protect the patient. The word emergency being written in the file is not sufficient by itself, however; the clinical findings, the pressure of time and the compulsory scope of the intervention should be understood from the records.
The procedure done in the emergency should not exceed the limit necessary to remove the danger. When the urgency ends, the patient, or the suitable representative, should be informed about the continuing treatment, the new interventions and the options. A planned and postponable procedure being conducted like an emergency only because of the institution's programme cannot be assessed in the same scope.
If there is a will of treatment the patient explained before, or a known refusal, its effect is examined separately. The possibility of reaching the legal representative, and the position of the child or of the person whose capacity to decide is limited, are also peculiar to the file. A general and automatic authority of intervention without consent cannot therefore be assumed for emergencies.
The capacity to decide, and the relation of representation
The will of the adult patient who has the capacity to decide is the basis. The spouse, the child or another relative giving the medical decision in the patient's place is as a rule not sufficient. The relative's view can help to understand the patient's wish; the authority of representation and companionship are not the same thing, however. The patient having difficulty in communicating does not mean, in every case, that there is no capacity to decide. Suitable support, translation or an accessible account should be provided.
In children, and in the other cases where representation is required by law, the relation of legal representation gains importance. Even so, the child or the young person should be informed about the process to the extent of their age and level of understanding. If the representative's decision openly conflicts with the child's benefit, special mechanisms of protection can come onto the agenda. This area is dependent on the event to a degree that cannot be reduced to a single rule of signature.
If it is claimed that the patient could not understand the information because of pain, medicine, sedation, the mental state or a language barrier, the clinical and time records are examined. Information is not only saying the information, but conveying it in a way that can be understood.
Did the procedure that was done exceed the limit of the consent?
It is assessed separately that a different or a wider procedure was done while the patient had consented to a certain intervention. During the surgery a finding that could not be foreseen beforehand, and whose delay would give birth to a serious danger, can appear. In such a case the necessity of the additional procedure, its scope and why it could not be expected should be understood from the operation notes. Options that could be foreseen beforehand are expected, if possible, to be spoken with the patient before the intervention.
To examine the limit of the consent, the plan of the surgery, the consent form, the operation note, the pathology and the records of the material that was used are compared. The names of the procedures being different in the documents does not always mean the limit was exceeded; there can be medical terms, or compulsory technical adaptations during the procedure. If an entirely different organ or procedure is in question, the need for an explanation strengthens.
The patient's general word do whatever is necessary cannot be interpreted as an unlimited authority of intervention. A balance is established, according to the concrete conditions, between medical necessity and the patient's autonomy.
A deficiency of information and a technical fault should be separated
Whether the intervention was done in conformity with the medical standard is the subject of the examination of medical malpractice. A deficiency of information focuses on the patient's right to decide. Both can exist in the same file, or only one can be debated. A known complication, for example, may have realised without a technical fault, but this important risk may not have been explained to the patient. Conversely, even if the risk was explained in detail, the application may have been conducted contrary to the standard.
As regards compensation, the connection between the deficiency of information, the risk that realised and the patient's decision process is examined. Whether the patient would have refused the intervention if sufficient information had been given, whether the alternative was realistic, and whether the harm stayed within the scope of the risk that was not explained, can matter. Not every deficiency of the form gives birth to the same legal result.
The content and the conditions of the information should therefore also be included in the file, alongside the technical expert examination. If the report examines only the surgical technique and leaves the problem of consent unanswered, the legal assessment can stay incomplete.
How should the documents and the order of proof be built?
The patient file, the consent forms, the information brochures, the appointment records, the examination notes, the times of the procedure and of the medicine, the interpreter records and the correspondence can be gathered together. The request for the document should be made as early as possible, and in writing. The guide requesting the patient file offers a practical frame for access to the records.
These dates can be shown separately on the timeline of the event:
- The day the suggestion of the intervention was made
- The claimed time of the information meeting
- The date and the hour the form was signed
- The time of the intervention, and of the sedation if there is any
- The date the risk realised, or was learned
- The later explanation and the applications
A witness account can provide support in some conditions, but it is assessed together with the medical records. The patient applying on their own to methods such as a sound or image recording can create problems of personal data and of criminal law, so conformity with the law should be assessed separately. The safe path is to gather the existing official and written records.
The paths of application do not serve the same aim
An application to patient rights inside the institution can provide an explanation of the event and an administrative examination. A professional inspection, a criminal investigation and the process of compensation have different conditions and results. The process of a complaint about a doctor explains the basic separations between these paths. The text of the application should show with which risk, which procedure and which date it relates the wide claim that nothing was explained.
For a violation claimed to have been made in a public hospital, administrative liability and the rules of a prior application can come onto the agenda. The path of compensation in a public hospital takes up the main lines of this procedure. In private-hospital files the private-law relation and the institution's responsibility for organisation are assessed separately. If the competent authority is chosen wrongly, a loss of time can be lived.
In the health institutions in Ankara too, the principles of information and of consent rest on the legislation across the country. The operation of the institution, or the local volume, can affect the tempo of gathering the evidence; it does not change the essence of the right. The periods should be determined in the concrete file according to the institution and the kind of request.
Applicable next steps
If it is thought that the intervention was made without information, the safe order is to meet the continuing need of health, to take the file and the consent documents, to form the timeline of the event, to separate the risk that was not explained from the result that realised, and to determine the path of application suited to the character of the institution. A measured and official language being used, in place of a public accusation, provides a focus on the merits of the file.
Not every deficiency of information is a technical medical error; not every signed form is counted as proof of complete information either. The emergency, the capacity, the representation, the scope of the procedure and the harm that appeared should be assessed together. For the general frame of health disputes, the health law page can be examined.
The legal result changes according to the current legislation, the medical records and the concrete conditions of communication. Definite expressions such as if there is no form the right is born of itself, or if there is a signature there is no right, are therefore not reliable.
Where the record of consent is read from
The information is read from the consent form, from the risk that was explained and from the record of the procedure. Not every complication is counted as an absence of consent. An amount of compensation is not written.
The office in Çankaya does not choose the authority the file will go to.
Conclusion
This article is for general information. The document, the period and the procedure of the concrete event should be read separately; there is no promise of an outcome from memory.