This article appears in the May 2003 edition of the Catholic Medical Quarterly
Informed Consent: Between Ethics and Law
Franco Pilotto and Pierluigi Badon
Reproduced abridged and edited, from "Dolentium Hominum"
1. Informed Consent:
Medical practice cannot depart from at least implicit consent of the person who has to be treated: a surgical operation or medical treatment carried out against the will of the patient, or beyond his consent, is a violation of his dignity as a person. The sick person becomes an object of medical science and not a subject to whom is due free self-determination.
The duty to request consent and the right to give consent, after information has been provided on the purpose and nature of the procedure, its consequences and possible risks, remain an ethical as well as deontological requirement.
This concern derives from the evolution of medicine (which has become increasingly complex from a technical viewpoint) and from the relationship between the health care worker and the patient who are increasingly aware of, and participate in, the choices that relate to his health. Whereas in traditional medicine the medical doctor acted 'for and 'instead of the patient (Hippocratic-paternalistic medicine) and decided what he thought was most useful for the patient, today the patient co-operates with the doctor, taking part personally in what is done (medicine based on the idea of a contract). In the contemporary context, consent has become an
instrument by which to promote and ensure the autonomy of the patient. Consent for a simple medical act has become a synonym for capacity for interchange and co-operation between the health care worker and the user.
1.1 The Origins and Spread of Informed Consent
As a result of cultural dynamics and of English and American pronouncements on legislation and jurisprudence in which the right of the patient to complete information has been upheld, the ethical need for informed consent has over recent decades been accepted in Italy. In our country, this proposition only gained significant ground at the beginning of the 1990s, whereas in the USA - the country which first gave rise to informed consent - and in many other countries, it has been widespread since the beginning of the last century. (1)
The reasons behind this spread in recent years (2) are to be attributed to:
a new attitude on the part of people towards their own health, a phenomenon that has been the outcome of a rapid change in social sensitivity to this question
an increase in the number of complex surgical operations involving high risk to the patient numerous 'clinical trials' needing consent
increase in legal actions by patients against health care workers progressive legal recognition of the principle of the autonomy of the patient and his capacity to decide for himself
a changed relationship between the health care worker and the patient.
Today, the patient no longer trusts himself blindly to the doctor but, aware of his own rights, strives to understand and to take active part in decisions regarding his treatment. Thus we have passed from a paternalistic form of medicine to one based on contract, respecting these personal values of the individual.(3) Consent thus becomes a contract between the health care worker and the patient who no longer offers mere passive adherence to a medical decision but rather provides an expression of his own wishes, made possible by adequate information.
1.2 The Juridical Principles
The informed consent of the patient is an essential pre-condition for embarking on health care action. Its juridical foundation both protects medical activity and defends and upholds the rights of the patient.
At international level, the Nuremberg Code of 1947, a consequence of the experiments carried out by Nazi doctors during the Second World War, reaffirmed the right of the person to understand any medical research involved and to decide freely whether to take part. This Code also restated the duty of the doctor to explain clearly the medical issues, the various possibilities in the treatment, the risk/benefit ratio, and the possible complications.
Subsequently, the Helsinki Declaration of 1964, drawn up by the World Medical Association and added to by later codicils, formulated leading recommendations for doctors in biomedical research involving human beings. In particular, it upheld respect for the personal dignity and well being of responsible individuals.
Upon this Declaration are based the rules of good clinical practice in which the duties and rights of the doctor and patient are so defined as to ensure the highest protection possible for the subjects of clinical trials. (4)
The Principles of European Medical Ethics of 1987 state that 'except in emergency, the medical doctor will illustrate to the patient the predictable effects and consequences of the treatment. He will obtain the consent of the patient above all when the actions proposed involve serious risk. The medical doctor cannot substitute his own idea of quality of life for that of his patients'. This document admits that what is deemed good by the medical doctor may not always coincide with what is deemed good by the patient.
The National Committee for Bioethics published its document 'Information and Consent to the Medical Act' in June 1992. In this document the characteristics of valid consent are specified: the quality of information, the patient's ability to understand and his success in understanding, and his freedom to decide.
More recently, the European Convention on Human Rights and Biomedicine (1996), in article 5, states that 'an intervention in the field of health cannot be carried out without the person involved giving his free and informed consent.'
In our Constitution we find explanatory references to the importance of consent. Article 13 states that 'personal freedom is inviolable. No form of detention, inspection or personal search is allowed, nor any other restriction on personal freedom, unless by an act justified by the judicial authority and only in cases and ways laid down by the law . This is an article that is very general, but useful when we reflect on the nature of the freedom of the individual (the principle of self-determination). Article 32, instead, restates that the defence of health is one s fundamental and inalienable right and excludes every form of obligation to undergo treatment, on the basis of the principle of the autonomy of every individual, albeit with the exception of treatment underwritten by the law: 'nobody can be obliged to undergo specific treatment unless by requirement of the law; the law can never violate the limits imposed by respect for the human person . (5)
Article 33, moreover, the law which established the National Health Service (Law 833-1978), laid down that obligatory health care investigations and forms of treatment must ensure the consent of those who are subjected to such obligation. (6)
Some articles of the Penal Code also contain important juridical references to informed consent. Article 50 explains: 'A person who injures or endangers a right with the consent of the person who can give it in a valid way, cannot be punished'. The health care act is justified by this declaration: the same is true where damage can be caused to a person, as long as there is 'the consent of the person who has that right' and personal freedom is thus respected. This takes place within the limits imposed by article 5 of the Civil Code which forbids 'acts to one's body which give rise to permanent diminution of physical integrity, or are otherwise contrary to the law, to public order and to public decency'. When it is not possible for the medical doctor to obtain consent because of the serious condition of the patient, article 54 of the Penal Code declares:
'A person is not punishable for having committed the act when he has been forced to do so by the need to save himself and others from actual danger.' This Article stresses that this danger must not be potential but actual; that it must be serious and imminent; that it must take the form of 'danger of serious injury to the person, a danger not caused voluntarily by him, nor otherwise avoidable, and always where the fact is proportionate to the danger. We are dealing here with a 'state of need': the health care worker carries out an action because he is obliged to save the life of a person, as the gravity of the situation precludes inactivity.
Article 728 of the Penal Code punishes any treatment that leads to the subject losing consciousness without his consent; article 610 refers to private crime when anybody compels others to do, tolerate or omit to do something.
In a recent decision of the Penal Supreme Court of Florence ('Cass. Pen. N. 5639/1992, sulcaso Massimo ), the judges restated the right of a patient not to undergo forced health care treatment with the exception of cases specifically envisaged by the law; it stated that 'the doctor cannot do anything without the consent of the patient or against his will.
This demonstrates that the principle of the self-determination of the sick person has acquired in Italy connotations now shared at an international level and recognised by jurists for some time.
1.3 The Ethical Principles
Consent does not have so much a juridical (defensive medicine) as an ethical value. We should not, therefore, limit ourselves to seeing consent as a form of juridical protection. We should see it, rather, as a valid instrument for the defence of autonomy in decision-making and the freedom of the sick person.
In American society in the early 1960s a growing affirmation of the personal values of freedom and autonomy began to emerge: in face of the decision making-power of the state, citizens came to claim and uphold their own space.
The North American movement had the advantage of seeking an understanding between different ethical principles; in the 1980s, in North America, the philosopher Beauchamp and the deontologist Childress (8) identified the leading principles to be applied in relation to a health care problem of a technical-operative kind that involved ethical decision-making.
The principle of doing good: this principle forms the basis of the relationship between the health care worker and the sick person. It implies doing good to people in need or at least to the largest number of them (we encounter here a tendency to utilitarianism).
The principle of not doing harm: this expresses the need to promote the good of, and avoid causing injury to, every person.
The principle of autonomy: this principle affirms respect for self-determination, involving authenticity (the consistency of the actions of the sick person with his abilities and his values) and independence in relation to choices (the subject is aware of the problem and has the ability to reason and to act).
The principle of justice: this principle emphasises that all citizens in a community have equal access to its structures: as a result, people must be treated equally and each person offered his due.
These are prima facie principles: they all have the same ethical-decision making force, but, according to the conditions involved, one principle can stand out and dominate the others. They are thus variable and applicable to the actual situation between the health care worker and the clinical decision-making problem.
These principles have been criticised by personalism because of their inconsistency and their lack of anthropological foundation. The principles of ethical-personalist action (9), instead, affirm:
The principle of the sacredness of life and its inability to be disposed of at will: the right to life is natural and inviolable. Physical life, as a primary although not supreme good, cannot be disposed of at will.
The principle of totality of the therapeutic principle: the person must be approached in his totality, that is to say in terms of his physical, mental and relational component parts: there is a relationship between 'a part and 'the whole , with the part subordinated to the whole.
The principle of the double effect: according to this principle an action can have a positive and a negative effect. However, the positive effect cannot be subordinated to the negative effect.
The principle of solidarity: man being special, the good of each individual has a relationship with the good of society as a whole.
The principle of subsidiarity: all people must be allowed to participate actively in individual and collective development.
The principle of the exception: this principle enters the picture when there is a conflict of values and involves a balance of norms (conscientious objection; the principle of the lesser evil; and co-operating in evil).
From an ethical point of view, the question of consent is to be located within the sphere of the principle of freedom of responsibility, the principle of autonomy, and the principle of doing good. The health care worker must be aware of this in order not to act unethically.
One can thus affirm that both the ethical and the juridical aspects of informed consent set themselves the same objective: the defence of the human person with his rights and values.
1.4 The Characteristics and Modalities of Consent
As has already been observed in this paper, consent is both a right and duty, with ethical and juridical aspects.
The premises for the validity of consent, according to the document of the National Committee for Bioethics on 'information on and Consent to the Medical Act of 1992, are as follows:
The quality of information: the information must be clear, true, essential and exhaustive. It should be provided in a quiet environment, guarantee privacy, and give time - in order to allow the sick person to understand what is being proposed - and provide an opportunity to listen.
The understanding of information: the information must be adapted to the level of education and learning of the patient; the language must be simple, understandable, and not technical in character; and whether the information has been understood by its recipient must be assessed through verification.
The decision-making freedom of the patient: this means that the patient must not be influenced by people or situations (and the information offered by the doctor must not be slanted). in addition, the consent must derive from unconstrained consideration.
The decision-making capacity of the patient: the patient must be adult and in full possession of his mental faculties.
To have ethical value, consent must thus be:
Informed: the information must explain his clinical situation and the possibilities of treatment. This knowledge should be sufficient and of a kind to enable him to achieve e an autonomous change in his behaviour.
Explicit: the consent should be genuine, specific and documented, and expressly provided by the sick person.
Free: the information should not be influenced from outside (persons or situations), but must derive from an autonomous and aware inner reflection.
Authentic: if assistance is provided, consent must derive from one s right and be a personal choice under self-determination.
Immune from elements that make it invalid: the person must be of sound mind and understand the diagnostic therapeutic process.
He must be of adult age: a minor is not seen as capable of responsible actions; according to article 2 of the Civil Code, only 'with adult age does one acquire the capacity to perform all those acts for which a different age has not been established . But the opinion of a minor is taken into consideration as a determining factor, according to his age and level of maturity: between the ages of fourteen and eighteen a minor must take part in his medical decisions. (10)
If the patient finds himself in a state of temporary incapacity (for example he is not conscious as a result of anaesthesia) a condition of emergency arises. Need for explicit consent demands a moratorium if possible.
The exceptions to this involve the donations or receiving of blood, non-therapeutic clinical trials, and HIV testing (Decree of 15 January 19991).
Written consent (obligatory only in the above mentioned cases) is for actions of greater importance and involving danger, and to satisfy doctors legitimate caution.
What has been said above also applies to information that is supplied by the doctor: written documentation of consent alone, and not of the information provided, can legitimately lead to the supposition that consent has been acquired without due explanations being given to the patient. Although there is no express legal obligation to do so, therefore, it is correct conduct to provide a form indicating the information supplied by the doctor to the patient, signed by both parties, and attached to the clinical notes. (13)
Whether written or oral, consent must be explicit and informed: after clarifying doubts, the sick person must clearly express his wishes.
1.5 The Information Needed for Obtaining Informed Consent
The obligation to inform (14) lies with the doctor responsible for treatment, who formulates the proposed course of treatment and puts it into effect. If the subject has been hospitalised, this obligation lies with the person who is responsible for the ward, in line with the hierarchy set out by the hospital law n. 128 of 1969. The head of physician, however, can delegate this task to an assistant.
Although information is ultimately a medical act, the nurse, in the name of the defence of the rights of the sick person (in this case the right to informed awareness), is obliged to inform the patient. In the deontological code for nurses, article 42 lays down that the 'nurse listens to, informs and involves the person in order to explain the level of care that is guaranteed and to allow the person cared for to express his own choices'; and article 4.5 observes that the 'nurse, in helping and supporting the person in his therapeutic choices, guarantees the provision of information concerning the plan of treatment. He or she so works that the patient not only has clinical information available but also recognises his right to choose not to be informed.' (15)
The information provided must be effective, essential and exhaustive, (16) and in the case of a surgical operation it must concern: the diagnosis; the prognosis; the modalities of intervention; the modalities of anaesthesia; possible complications; the post-operative course; and alternative forms of treatment. All further information requested by the patient must be provided.
The information provided is not always sufficient: on its own, in clinical practice, it may not allow the doctor to establish a human relationship, or one based on trust, with the sick person. It is communication, literally 'being in contact with', that brings together the subjects of the relationship, at the possibly unconscious level and that allows psychological openness on the part of the patient, thereby facilitating a relationship of transparency, respect and mutual trust. (17) The relationship between the doctor and the patient, therefore must always be personal and based upon human dignity.
The information provided must be truthful and in proportion to the patient s capacity to understand, based on the patient s education and learning and his psychological condition. The language employed must be simple, understandable, not technical in character and suited to the recipient of the information.
The emotional condition of the sick person is of fundamental importance: he is often fragile, anxious about the diagnosis, and worried because of fear or lack of knowledge: With the exception of emergency, information should always be given, especially before a surgical procedure, on a par with a personal injury (Carnelutti, 1938). (18)
To conclude this section, respect for the principle of truthfulness is an essential precondition for the creation of a relationship based on trust: 'not telling the truth means not recognising capacity for self determination, to the detriment of the relationship with the health care worker, which should be marked by trust and respect for personal wishes . (19)
2. Informed Consent in the Doctor-Nurse Relationship
2.1 The evolution of the Relationship between the Health Care Worker and the Patient
Until a few decades ago, informed consent was taken as granted because of the dominance of an approach involving benevolent paternalism on the part of the doctor.
The doctor, seeking the good of the patient, was the principal decision maker, who took decisions on behalf of the patient. The patient, for his part, was the "object of treatment", a mere observer who obeyed because of the fact that his condition precluded self determination. (20)
During this period all other health care workers, including the nurses, were mere executors of the doctor's decisions.
However, benevolent paternalism entered into crisis about twenty years ago when people asked whether it was true that the sole purpose of medicine was to secure the good of the patient, and whether it was not the case that, in addition, medical practice has to respect the person s choices and values. This crisis precipitated the end of inequality between the doctor and the patient: the authority of the health care worker was now democratically shared with the patient, who no longer sat back and watched events but actively took part in the decisions regarding his treatment.
In this way, health care action is decided through a process of negotiations with consent the central point. The nurse is still a helper of the doctor but has acquired greater importance in the 'medical dialogue because he or she facilitates communication, thereby helping the patient be more autonomous and more informed.
The doctor and the nurse must contribute to the independence of the sick person and provide him with the knowledge necessary to ensure that his choices correspond to his real interests, but at the same time the doctor and the nurse cannot become mere passive executors of his will. (21)
The autonomy of the patient, in fact, is not absolute and does not take away the responsibility of the health care workers for his treatment: the patient has the duty not to make unsuitable challenges to the beliefs of the doctor and his right to freedom and responsibility. Health care workers, in addition to curing the illness, must guarantee the daily activity that keeps the patient alive and also help to foster his participation in the process of care (Colli�re 992). (22)
2.2 The Integration of the Doctor and the Nurse
Doctors and nurses are the two professionals of the relationship; (23) to inform the patient, in addition to being human and ethical, as they are also highly professional. The two should work together to offer better information and care to the patient. However, such co-operation is still rare in contemporary clinical practice.
Such a difficulty may arise from the authority of the doctor (understood as a power legitimated by law or morality which involves the right to give orders, to advise, and to command respect) and from an excessively technical character of the services that are provided, due, in part, to lack of time.
Although working with the doctor, the nurse should maintain his or her own personal and professional autonomy, which, indeed, will allow him or her to understand what is right and suitable for the patient by exchanging opinions with his or her colleagues and thus not confining himself or herself to an approach of passive acceptance: the mere carrying out of the provision of care.
In recent years the patient has moved from being the mere recipient of choices made by other people to being the protagonist of the decision-making process affecting his health. The epoch marked by benevolent paternalism by the doctor, the chief determiner of the situation, has been left behind, and the health care worker has established a new relationship with the user, a relationship based upon sharing. The user now has the opportunity to choose the treatment he wants, to agree to or reject the treatment proposed. The need for the patient to be informed is thus greater.
Informed consent lies at the centre: because it requires negotiation between the health care worker and the patient, it has become a litmus test for good feeling established (or otherwise) between them.
Without suitable information, clear, exhaustive and adjusted to the level of education and learning of the subject, valid consent cannot be acquired. For this reason, doctors and nurses must offer the patient all the information needed to enable the patient to be aware of the situation and autonomous.
Better communication between the health care workers themselves makes the exchange of information needed for the treatment and care of the sick person more effective. Ward meetings, more open and sincere dialogue, the joint acknowledgement of respective roles and mutual respect between doctors and nurses would foster the good of the patient.
In addition, health care workers should receive on going training and up-dating, and learn to engage in research: daily experience, attempts made and errors committed, allow them to understand what is not working and introduce possible changes in care and treatment.
Greater information, close co-operation between the staff of the ward and a critical attitude towards one s own work, are essential if we want to improve not only the practice of informed consent but all the forms of care and treatment provided.
It is important to engage in discussion because only in this way is it possible to accept change. Alteration of care and treatment can cause concern within a team, especially if one is dealing with methods acquired and consolidated over time. But the desire to improve must overcome this difficulty; and the primary goal of care and treatment is always the well being of the patient.
- Sgreccia E. Spagnolo A., Pietro M.L. Bioetica Manuale per I diplomi universitari della Sanita (Vita e Pensiero, Milan 1999)
- Spinsanti S. Bioetica in Sanita (La nuova Italia Scientifica 1993)
- Spinsanti S., Dall educazione sanitaria al consenso informato (Mediamix, 1995)
- Sgreccia E., Spagnolo A., Pietro M.L. Bioetico, Manuale per i diploma universiafri della Sanitari (Vita e pensiero Milan. 1999) Nursing oggi, n.1.,2000 Il consenso informato nei tratamenti sperimentali: ruolo dell infermiere
- Sgreccia E., Spagnolo A., Pietro N.L. Bioetico, Manuale per i diploma universiatri della Sanita 1999
- Benci L., Manuale giuridico proJ�ssionale per l esercizio del nursing (McGraw Hill, Milan (1996)
- see note 5
- Beauchamp T.L., Childress J.F. Principi di etica biomedical (Casa Editrice Le Lettere, Florence 1999)
- Sgeccia E., Manuale di Bioetica Aspetti medico-sociale (Vita e Pensiero, Milan 1996)
- Recenti sviluppi in materio bioetico, in margine al progretto di Conventione sulla bioetica del Consiglio d Europa (Giappichelli Editore, Turin)
- Comitato Nazuionale per le Bioetica, Informazione e Consenso all 'atto medico, 20 June 1992
- Fucci S. Informazione e consenso nel rapporto medico-paziente (Mason, Milan 1996)
- see note 12
- Jandolo C., L'etica al letto del malato (Armando Editore, Rome 1990)
- Calamandrei C., D Addio L., Commentario nuovo Codice Deontologico dell infermiere (McGraw Hill 1999)
- Spinsanti S., Bioetico in Sanita (La Nuovo Italia Scientifica 1993)
- Santosuosso A., Il Consenso Informato (Raffaello Cortina Editore, 1997)
- Carnelutti F., 'Obllighi poteri e diritti del malato e del chirurgo' 1938 from the review Alfonso Marra. IL Consenso Informato.
- Sgrecci E., Spagnolo A., Pietro M.L., Bioetico Manuale per I diploma universitari della Sanita (Vita e Pensiero, Milan, 1999)
- Spinsanti S. Bioetica nella professione imfermieristica (edizione Edises, Naples, 1995)
- Jandolo C. L'etica al letto del malato (Armando Editore, Rome 1990)
- Colliere M.F., Aiutare a vivere, dal sapere delle donne al 'asistenza infermieristica (ed Sorbona 1992)
- Novarini A., Comunicare co il malato una componente essenziale del 'saper essere nella formazione del medico. La Formazione del Medico, 1996, vol. 10, n.2.
Professor Franco Pilotto is Lecturer in Bioethics in the University 'Regina Apostolorum' Rome.
Professor Pierluigi Badon is Lecturer in Clinical Nursing at the University of Padua and the University of Udine.