How informed the patient consent should be?

patient informed consent
patient informed consent


Respect for autonomy sets the ethical and legal norms that allow patients to decide about their medical treatments. The doctors must provide the patients with information regarding their medical status and all the material risks. Sometimes two or more doctors inform the patient about the same medical procedure. The medical data are not presented in the same way by the doctors. The puzzled patient could experience difficulties in retaining and processing the medical information and the procedure of obtaining the informed consent may be affected.


Tablet of Contents:

1. Introduction

2. Metodology

3. Results and Discussions

4. Conclusions


1. Introduction

Respect for autonomy in the medical context implies that patients, and not their doctors, have the right to decide about their medical treatment. Doctors may comprehend the medical issues, but only the patient knows his or her own values, which will ultimately determine the patient decision in favor or against the medical procedure. Neither the state, the community, nor a paternalistic, if well-meaning health professional, is entitled to dictate the medical treatment that a competent adult patient will undertake[1].

The lawmaker turns this recommendation into legal norms applicable to medical practice [2].

Breaking the legal requirements regarding the patient informed consent may lead to the medical staff civil liability. Where the conditions of civil liability are met the doctor acquires the obligation to compensate for damages incurred. The moral damages that patients can thus get are an important risk because these damages are estimated in a subjective manner, and usually the highest money indemnities are granted for them [3].


2. Metodology

This article is a case study.


3. Results and Discussions

Pregnant patient aged 18 years old with 39 weeks pregnancy with diagnosis of thrombophilia presents in the emergency department with systematic painful uterine contractions. Her obstetrical record was significant for a caesarian section 1 year ago.

Taking into the consideration the symptoms and obstetrical past, it is decided to admit the patients in 2nd Department of Obstetrics and Gynecology, of Pius Brinzeu” Emergency Clinic County Hospital of Timisoara. The on-call obstetrician, explains the patient her medical situation, and proposes delivery through caesarian section due the potential risk of uterine rupture. The presence of the uterine scar and the diagnosis of thrombophilia are two conditions which need special medical care, because severe complications could occur [4].

The patient agrees to the admission, consultation, fetal ultrasound and caesarian section. After the on call medical consultation, the patient was sent in the maternity ward, where the specialized personnel, will attend her delivery and assure the proper follow-up management.

The medical team gives information about the patient’s operation and further postoperative management and gets a second consent from the patient. The second consent was obtained because the current doctor concluded that the on-call doctor could not offer enough details about the identity and the medical status of the personnel that will provide care in the maternity ward.

The patient puzzled about the second set of information, mostly because the presented data was not 100% identic to the first explanation. After few hesitations, the patient signed the second consent.


How much information should be provided to the patient?

In US, Canada, Australia the doctor must disclose all material risks. A risk is material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forgo the proposed therapy’. In United Kingdom the doctor will have discharged his obligation if he counsels the patient in a way that would be endorsed by a responsible body of medical opinion. In European Union the European Convention on Human Rights (Article 8) robustly protects patient autonomy [5].

In Romania the medical law is young (therefore not very well known by doctors) [6] and contains detailed requirements. The patient should receive at least the following information before signing the informed consent form: the medical act to be subjected to [7], health status, diagnosis, proposed medical interventions, nature and purpose of treatment, risks and consequences of treatment, treatment alternatives and their risks and consequences, prognosis of the disease without treatment, available medical services and the way in which they can be used, identity and status of caregiver, including physician, the rules and habits to be respected in the medical unit/cabinet [8, 9].


Full disclosure for every patient?

Information regarding a bad prognosis is a bitter pill to swallow. Some patient may consider that the information regarding their medical status could induce them harm. For instance, the Navajo population from US has this belief: Thought and language have the power to shape reality and to control events”.

Telling a Navajo patient about the potential complications of his disease may actually produce

those complications because: language does not merely describe reality, language shapes reality [10].

The medical law also states that the patient has the right to refuse to be informed. According to the Romanian law, the patient has the right to decide if he/she still wants to be informed if the information presented by the doctor would be harmful to him/her [11].


Too much information is beneficial for the patient?

In our case study both the ethical and legal requirement were met, the patient was informed in compliance with all the legal requirements. More than that, two different doctors informed the patient about the same medical act.

The patient became confused and suspicious because the information was slightly different.

In our opinion, the responsibility for explaining the risks should be clearly established. If more than one person assumes this responsibility, contradictory messages may be given.

Therefore, it is important to ask patients what they have been told by others and explain them the reason for obtaining a second consent for the same medical intervention.


4. Conclusions

Knowledge is power and the patients should receive as much as possible so that they can make informed decisions.

From an ethical perspective it is difficult to decide the suitable amount of information the patient should be provided with. From a legal perspective it is easier because the medical law sets minimal/mandatory requirements for this process.

Both from ethical and legal perspective the patients have the right to refuse to be informed. On the other hand, too much information can be confusing and could adversely affect the patient informed consent procedures.


The Authors:

PAUN Silviu Dumitru [1]

MOZA Andreea [2]

EDU Antoine [3]

BIRSANU Sinziana Elena [4]

DUTA Alexandru [1]

[1] University of Medicine and Pharmacy Carol Davila”, Department 14 Orthopedics, Anaesthesiology and Intensive Care, Bucharest (ROMANIA).

[2] Victor Babes” University of Medicine and Pharmacy from Timisoara, Department of Obstetrics and Gynecology, Timisoara (ROMANIA).

[3] University of Medicine and Pharmacy Carol Davila”, Department 13 Obstetrics and Gynecology, Bucharest, (ROMANIA).

[4] Bucharest Barr Association (ROMANIA).


Contributo selezionato da Filodiritto tra quelli pubblicati nei Proceedings “13th National Conference on Bioethics with International Participation - 2018”

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Contribution selected by Filodiritto among those published in the Proceedings “13th National Conference on Bioethics with International Participation - 2018”

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1. Braun, A.R., Skene, L., Merry, A.F. (2010). Informed consent for anesthesia in Australia and New Zealand. Anaesth Intensive Care 38, pp. 809-822.

2. Nanu, A., Bulgaru-Iliescu, D., Rotaru, T.S., Oprea, L. (2015). The Gap between Bioethics Principlism and Judicial Responsibility: How Social Sciences Can Help Romanian Law. Revista de cercetare si interventie sociala 49, pp. 216-228.

3. Nanu, A., Georgescu, D., Bulgaru, D., Berteanu, M., Radulescu, C. (2012). Using the International Classification of Functioning, Disability and Health in assessing moral damages. Romanian Journal of Legal Medicine 20(1), pp. 77-82.

4. Ionita, I., Grigorita, L., Miloicov, C.B., et al., (2017). The Role of Thrombophilia in Pregnancy. Revista de Chimie 67(12), pp. 2643-2647.

5. Charles, F. (2013). Medical Law, A very short introduction, Oxford University Press, pp. 57-58.

6. Nanu, A., Georgescu, D., Voicu, V., Ioan, B. (2011). Place and relevance of legal provisions in the context of medical practice in Romania. Romanian Journal of Bioethics 9(4), pp. 90-101.

7. Ministry of Health, Order no 483/20017, art 8, available in Romanian.

8. Parliament of Romania, Law no. 95/2006 on health-care reform, republished, Official Journal of Romania, 1st part, no. 652/2015, art. 649, available in Romanian.

9. Parliament of Romania, Law no. 46/2003 regarding the patient rights, art. 4,5,6, available in Romanian.

10. Beauchamp, T.L., Childress, J.F, (2009). Principles of Biomedical Ethics, sixth edition, Oxford University Press, pp. 105-107.

11. Parliament of Romania, Law no. 46/2003 regarding the patient rights, art. 9, available in Romanian.