Informed consent

Before touching on the concept of informed consent, it would be appropriate to start by explaining the concept of medical intervention. In its simplest form, medical intervention can be defined as "the interventions carried out by a physician or a healthcare professional authorized by legal legislation in order to diagnose, treat and prevent the patient's anomalies, in accordance with all the technical requirements and professional ethics that medicine has reached today." In order to understand the scope of the concept of medical intervention, examples can be given such as "vaccinating the person, performing the necessary analysis and clinical examination to diagnose the disease, performing surgical intervention, keeping the patient under surveillance and regulating his/her mental life...".

Informed consent; It is the process of obtaining the patient's consent after giving the patient a reasonable period of time to think and decide, after the physician who will perform the intervention explains the diagnosis to the patient, treatment options, what the medical intervention to be applied is, what the complications of the intervention are, if any, and their consequences, in a simple and understandable language free of medical language, taking into account the patient's culture and education level, and ensuring that what he explains is understood by the patient.

LEGAL BASIS OF INFORMED CONSENT

Constitution Art. 17. "Everyone has the right to live and to protect and develop their material and spiritual existence. Except for medical necessities and cases written in the law, a person's physical integrity cannot be violated; he cannot be subjected to scientific and medical experiments without his consent."

TMK Art. 24 "Unless the consent of the person whose personal rights are violated is justified by one of the reasons for a higher private or public benefit or the exercise of the authority granted by law, every attack on personal rights is unlawful."

TCK Art. 26 "No one shall be punished for an act committed within the framework of his/her expressed consent, regarding a right over which the person can absolutely exercise control."

The provisions of the article form the legal basis of the concept of informed consent. Because the rights of the individual such as the right to life, the right to self-determination of his own future, the right to protect his physical integrity and the ability to exercise his health rights are among the personal rights protected at the constitutional level.

Article 24 of the Patient Rights Regulation states that "The patient's consent is required for medical interventions. If the patient is a minor or disabled, permission is obtained from his/her parent or guardian. In cases where the patient's parent or guardian is not present or cannot be present, or the patient does not have the power of expression, this condition is not required. Even in cases where the consent of the legal representative is sufficient, the patient must be informed as much as possible by listening to the minor or restricted patient, to the extent that they can understand what is being explained, and Participation in decisions regarding treatment is ensured.” It is stated as follows.

Obtaining the patient's consent before any medical intervention is considered a prerequisite both legally and in terms of the ethical rules of the medical profession. Therefore, a medical intervention performed without the person's consent will be against the law and professional ethics.

FORM OF INFORMED CONSENT

Article 70 of the Law No. 1219 on the Execution of Medicine and Medical Arts "Physicians, dentists and dentists must first obtain the consent of the patient, or if the patient is a minor or incapacitated, his/her parent or guardian, for any surgery they will perform. This consent is required for major surgeries. It must be in writing." It has been said. Accordingly, except for important medical interventions, obtaining the patient's consent is not subject to any specific procedure. It can be done verbally or in writing. However, with the increase in lawsuits and penalties imposed on this issue, it has become a common practice to obtain the patient's consent in writing in order to avoid difficulty of proof. The method of having people sign a printed form without any information, which is frequently encountered in practice, is an extremely erroneous practice. This consent obtained without informing the patient will not be considered as a legally valid consent.

It should not be forgotten that the clauses in the clarification forms that aim to remove the legal and criminal liability of the physician will not have legal validity. Article 115 of the Code of Obligations states: "If a service, profession or art that requires expertise can only be carried out with the permission given by law or competent authorities, the agreement made in advance stating that the debtor will not be responsible for a slight fault is absolutely null and void." This situation is clearly stated in the statement.

IMPORTANCE OF INFORMED CONSENT

The purpose of informed consent is; It is the protection of the patient's personal rights and the right to benefit from health services, as well as ensuring the patient's participation in the medical decision when making decisions about the medical procedure to be performed, and therefore ensuring that the patient and the physician cooperate.

In practice, the first action taken in cases arising from medical malpractice is to check the patient's file and see whether informed consent has been obtained. One of the reasons that has increased the number of penalties in malpractice cases recently is the lack of informed consent. Obtaining the patient's written consent before any medical procedure not only ensures the protection of the patient's rights, but also serves as evidence that physicians can use in their favor in future legal situations.

PHYSICIAN'S OBLIGATION TO RESPECT PATIENT AUTONOMY

The concept of respect for autonomy is one of the important principles of medical ethics as a natural consequence of the point reached with the increase in human relations and the increase in the importance given to human life and personal rights. Obtaining informed consent from the patient before any medical procedure is the most important criterion in terms of the physician's obligation to respect patient autonomy. Medical indication determines the limit of respect for patient autonomy. Medical indication means "necessity" in the medical literature. In the case of a patient who requests treatment for which there is no medical indication, the physician's obligation to respect the patient's autonomy can no longer be mentioned. Medical indication not only limits the autonomy of the patient, but also is a factor that determines the limit of medical intervention by the physician. In order for the physician not to be legally responsible, it is necessary to have legal reasons such as medical indication and patient consent. A medical intervention without a medical indication or a medical intervention without the patient's consent will result in both legal and criminal liability of the physician.

SCOPE OF CLARIFICATION OBLIGATION

The matters that need to be informed before the patient's consent is obtained are regulated in detail in Article 15 of the Patient Rights Regulation. Namely;

"To the patient;

a) Possible causes of the disease and how it will progress,

b) By whom, where, in what way and how the medical intervention will be performed and its estimated duration,

c) Other diagnosis and treatment options, the benefits and risks of these options and their possible effects on the patient's health,

ç) Possible complications,

d) Possible benefits and risks that may arise in case of rejection,

e) Important features of the drugs to be used,

f) Lifestyle recommendations that are critical for one's health,

g) If necessary, information is given on how to get medical help on the same issue."

Concerning the diagnosis of the disease, the physician should enlighten the patient in a simple and clear language about how he reached this diagnosis and the findings of the disease, and ensure that the patient understands exactly what his disease is. In order not to undergo medical intervention, the physician should inform the patient about the course of the disease and the problems he may experience. Regarding the treatment of the disease, the physician must explain to the patient what the alternative treatment methods are, what the preferred treatment is, the path to be followed, the duration of treatment, the drugs to be used and the common side effects, if any, and finally the patient must be informed about what kind of treatment will be applied to him. Regarding risk clarification, the physician should inform the patient about the possible complications and harms that the patient may encounter as a result of the medical intervention to be applied. The dominant view adopted by the Supreme Court on this issue is that even the most remote risks should be conveyed to the patient.

The issue was discussed in a recent Constitutional Court decision and it was decided to first examine the consent form and, if necessary, obtain an expert report on the form. Relevant parts of the decision are as follows:

"As for the evaluation of the allegation that the procedural aspect of the right to life was violated, the report prepared by the Expertise Board by examining the medical documents about M.E. stated that M.E.'s portal vein injury was a complication that developed during the surgery and that the death occurred as a result of liver failure and its complications that developed after the surgery. The court also rejected the case based on the said report. In this regard, the applicant's claims were discussed based on concrete findings and determinations in terms of the claim regarding doctor's negligence. However, although the applicant claimed that the obligation to inform was not fulfilled by not informing that the surgery would be started as a closed surgery in the petition and claimed that they were not informed about the process in the petition dated 28/11/2019 and requested a new report from the High Medical Board of the Institute of Forensic Medicine, the Court decided whether the informed consent form required to be taken during the surgery process of M.E. was received, what was the scope of the said form and whether the form included risks that may occur during the surgery and cause the applicant's death. However, considering the applicant's allegations, an evaluation should have been made on the mentioned issues, including an expert examination, if necessary. Therefore, it cannot be said that the Court carried out an examination with the rigor required by Article 17 of the Constitution.

For the reasons explained, it must be decided that the procedural aspect of the right to life guaranteed in Article 17 of the Constitution has been violated." (25/6/2025 T. 2021/56334 B.NO)

HOW TO OBTAIN INFORMED CONSENT?

1-The physician informs the patient properly

Patient Rights Regulation Art. 18 "Information is given as simply as possible, without hesitation and doubt, in a way that the patient can understand in accordance with his social and cultural level. The patient is informed verbally about the medical intervention by the healthcare professional who will perform the medical intervention. In cases where the healthcare professional who will provide information and medical intervention must be different, information can be provided by another healthcare professional who is competent to inform the patient by making an explanation regarding this situation. It is essential that the patient himself is informed. Informing someone else instead of the patient himself. "In case of request, this request is recorded in writing with the person's signature, and only the persons who are requested to be informed are informed. The patient may also request a second opinion about his health condition from another physician regarding the same complaint. Except for emergencies, the patient is informed within a reasonable period of time. The information is provided in a suitable environment and by protecting the patient's privacy. If the patient requests, information regarding the cost of the procedure to be performed is given by the relevant units of the health service provider."

2- The patient whose consent will be obtained must have the capacity to express consent

According to the Turkish Civil Code, persons who have the capacity to act are competent to express consent. For this, it is necessary to be an adult and have the power of discrimination. Patients who have legal capacity are informed and their consent is obtained. In cases of mental illness or minors, consent is obtained from their legal representatives.

3-The subject of consent must be in accordance with law and morality

The subject of consent must be a subject approved by the legal order and in line with social values. For example, if an internal organ of a person is removed upon the patient's request even though there is no medical necessity, the crime of intentional injury will come to the fore.

CONSEQUENCES OF NOT OBTAINING INFORMED CONSENT

Failure to provide or incomplete information constitutes a violation of the power of attorney agreement between the patient and the physician. The patient's decision regarding medical intervention and the deprivation of his/her right to participate in the decision constitute a violation of personal rights and are within the scope of tort. Medical intervention performed without consent will become unlawful. In case of violation of the obligation to inform, if it occurs under other circumstances, the physician's liability for compensation and tort liability in terms of criminal law will come to the fore.

THE DOCTOR'S OBLIGATION TO INFORM IN THE LIGHT OF THE SUPREME COURT DECISIONS

In cases where the physician violates the obligation to inform and inform the patient about the medical interventions to be performed, the medical intervention will be considered unlawful and legal and criminal liability may arise. As is known, the burden of proving that the patient has been informed and given consent before medical intervention is on the physician or the hospital. Therefore, failure to properly inform patients or deficiencies in disclosure forms may result in malpractice cases being concluded against physicians. The obligation to obtain the patient's informed consent before medical intervention is clearly regulated both in international agreements signed by Türkiye and in our domestic legislation. In the light of the Supreme Court decisions, the importance of the obligation to inform and the responsibilities that may arise from physicians in case of violation will be more clearly understood. Namely;

"… Regulations parallel to the established practices of our department have been introduced. Merely consenting to surgery is not enough. In addition, complications must be explained. However, this consent must be informed consent, as emphasized above. As a matter of fact, article 26 of the Physician Ethics Regulation has been regulated and "The physician examines his patient, the patient's health condition and the diagnosis made, the type of the recommended treatment method, the chance of success and its duration, the risks of the treatment method for the patient's health, the risks of the given drugs." It clarifies its use and possible side effects, the consequences of the disease if the patient does not accept the recommended treatment, possible treatment options and risks. The lighting provided should be appropriate to the patient's cultural, social and spiritual status. Information should be given in a way that can be understood by the patient. The patient himself determines the people to be informed other than the patient. Any health-related intervention can be done with the person's free and informed consent. The consent obtained is invalid if it was obtained through pressure, threat, insufficient information or deception. In emergencies and in cases where the patient is a minor or unconscious or unable to make decisions, the permission of the legal representative is obtained. The arrangement explains how the lighting will be done. In informed consent, the burden of proof is on the physician or hospital.

Therefore,it is imperative for the defendants to inform the patient about the possible results and complications that may occur before the surgery. There is no approval document submitted to the file. It cannot be understood from the content of the file that the defendant party informed the plaintiff about this issue and warned him by making reasoned explanations, whether the plaintiff was adequately informed, and whether the plaintiff would consent to this operation even if the complications of the operation were known. In this case, while the defendant's evidence, if any, should be collected and a decision should be made based on the result, making a decision based on incomplete examination is against the procedure and the law and requires reversal."

(13.HD. 28.10.2013, 2013/17027-26132)

"… It is an obligation for the defendant to inform his patient about the results and complications that may occur before the surgery, according to Article 357 of the Turkish Code of Obligations. As the court accepted, the consent form submitted to the file is printed, and whether the defendant informed the plaintiff about this issue and warned him by making reasoned explanations, and whether the plaintiff was adequately informed, whether the plaintiff was subject to this operation even if the complications of the operation were known. "The issue of whether the defendant will consent or not cannot be understood from the content of the file. Therefore, while a decision should be made based on the outcome of the defendant's evidence on this issue, making a decision based on incomplete examination is against the procedure and the law and requires reversal."

(13. HD. 13.06.2013, 2013/14354-16113)