Autonomy, consent and responsibility. Part 1: Limitations of the

Autonomy, consent and responsibility. Part 1: Limitations of the

Radiología. 2016;58(5):343---351
www.elsevier.es/rx
UPDATE IN RADIOLOGY
Autonomy, consent and responsibility. Part 1:
Limitations of the principle of autonomy as a
foundation of informed consent夽
J.M. Mellado
Servicio de Radiología, Hospital Universitario Miguel Servet, Zaragoza, Spain
Received 5 March 2016; accepted 10 June 2016
KEYWORDS
Right to autonomy;
Patients’ rights;
Informed consent;
Bioethics;
Law;
Code of ethics;
Professionalism
PALABRAS CLAVE
Derecho de
autonomía;
Derechos
del paciente;
Consentimiento
informado;
Abstract Legal recognition of patient’s rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and
the abundance of regulations. For several years, autonomy, consent, and responsibility have
formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual
and regulatory limitations of the principle of autonomy as the basis of informed consent. We
approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health
care and its relationship with legal responsibility.
© 2016 SERAM. Published by Elsevier España, S.L.U. All rights reserved.
Autonomía, consentimiento y responsabilidad. Parte 1: limitaciones del principio
de autonomía como fundamento del consentimiento informado
Resumen La consolidación legislativa de los derechos del paciente introdujo modificaciones
en la relación clínica y en la lex artis, pero su implantación progresa con dificultades en un
entorno sanitario muy condicionado por la escasez de los recursos y la abundancia de las
normas. Desde hace algunos años, la autonomía, el consentimiento y la responsabilidad forman
夽 Please cite this article as: Mellado JM. Autonomía, consentimiento y responsabilidad. Parte 1: limitaciones del principio de autonomía
como fundamento del consentimiento informado. Radiología. 2016;58:343---351.
E-mail address: [email protected]
2173-5107/© 2016 SERAM. Published by Elsevier España, S.L.U. All rights reserved.
344
Bioética;
Ley;
Código deontológico;
Profesionalismo
J.M. Mellado
uno de los ejes vertebradores de la profesión médica. Sin embargo, son objeto de controversia y causan malestar profesional. En la primera parte de este artículo examinamos las
limitaciones conceptuales y normativas del principio de autonomía como fundamento del consentimiento informado, abordadas desde una perspectiva filosófica, histórico-jurídica, bioética,
legal, deontológica y profesional. En la segunda parte analizamos la viabilidad del consentimiento informado en la medicina asistencial y su relación con la responsabilidad jurídica.
© 2016 SERAM. Publicado por Elsevier España, S.L.U. Todos los derechos reservados.
Introduction
It is said that something needs to change so that everything remains the same.1 Perhaps that is what has happened
with informed consent (IC).2---4 Thirty-eight years after the
publication of the Belmont Report5 there are still doubts
about the actual capacity of IC to ensure the patient’s
autonomy.6---10 Everything seems to indicate that the standards intended to eradicate paternalism have not fully
reached their goal. As a matter of fact, they have not prevented the increase of lawsuits, of defensive medicine and
professional dissatisfaction.8---15 The physician’s attitude may
have ruined some good purposes. Without ruling out this
hypothesis, we will try to explore others. Our goal is to
examine the conceptual and normative limitations of the
principle of autonomy as the foundation of IC.
The interruption of Hippocratic tradition
The Hippocratic Oath, paradigm of the self-normative tradition of the medical profession, has had a lasting influence.16
Hippocratic medicine was respectful of the patient’s dignity,
but at the same time it was snobbish and very paternalistic.
Sheltered by this tradition, the physician has practiced for
a long time regardless of the patient’s desires and not very
conditioned by the law. The traditional physician’s moral
prestige and his dedicated service vocation seemed enough
to vouch for his conduct.17---19 However, this situation has
changed.
The scientific breakthroughs of the previous century
arouse great expectations as well as social alarm. Ideological pluralism contributed to a gradual demystification
of the medical profession.19---21 The welfare state promoted
public health that understood health as perfect physical,
mental and social wellbeing.22 In this context, the irruption of bioethics, since the 1970s, proved decisive for the
legislative development of the patient’s rights.
Thus emerges a more regulated medicine integrated in a
healthcare organization that protects health with criteria of
universality. The clinical relation is humanized. Control elements are introduced that modify or replace the relationship
of trust.23 The new medical act needs to be beneficial, necessary, consensual, safe and fair. It must have quality and
seek satisfaction.24 In view of an adverse result, risk materialized as damage becomes the axis of procedural debate,
which stimulates defensive medicine.25
The patient has become both the user of public services and the consumer of health products. They intend to
enjoy the health the law guarantees for them. In turn physicians long for a more spontaneous medicine. They practice
with a sense of resignation, conditioned by the lack of
resources and the overabundance of rules.26,27 Skeptical of
the formidable proposals of academic ethics, they wonder
whether they are being asked too much.28 They resist where
possible, being the IC one of the stages of such resistance.
Autonomy as a philosophical concept
Autonomy is a basic concept of the legal organization and
ethical foundation of liberal and democratic societies.29
It originates in the moral and political philosophy of the
West. It is associated with terms such as liberty, independence, willingness, authenticity and responsibility. It is part
of the educational, bioethical and medical language. The
autonomous individual is aware of his/her own purposes and
capable of exercising his/her own will. He/she makes decisions based on his/her own needs and takes responsibility
for it.29
Autonomy can be understood as the capacity to
act with independence, the possibility of acting with
willingness or the right to decide freely.29 To Kant, autonomy is rational self-government through universal moral
regulations.30 To Mills, autonomy seeks the utmost wellbeing, it entails sovereignty and is identified with an absence
of coercion.31,32 Autonomy can be a praiseworthy aspiration
or a reputable capacity. It can work as an instrument, but it
is also an end in itself that is worth guarding.29
The notion of autonomy is controversial.33 Its dominating meaning prioritizes individual rights, avoids personal ties
and tends to radicalism. Many authors are suspicious of this
autonomy or believe it is improbable. Some claim that emotions disqualify it. Still others believe that it is a myth or a
fiction, an expression of magical voluntarism or outdated liberalism. Many author think it is no compatible with justice,
solidarity or trust.33---41
Autonomy as a legal structure
Autonomy becomes a procedural argument in the early
decades of the 20th Century in the United States. The
US Constitution and its amendments recognize the individual’s right to self-determination. In this context, there is a
Autonomy, consent and responsibility
number of lawsuits due to physical damages derived from
medical acts that would prove decisive for the juridical
design of IC. Three essential prerequisites are three: capacity, information and willingness.42
In several pioneering judicial resolutions legal liability
is attributed to the physician who does not inform the
patient truthfully or does not obtain his/her consent properly. Nevertheless, first it must be proven that lack of
information deprives the patient of the opportunity to reject
the treatment. The first convictions of this kind are based
on the falsehood of the information, on its biased character, on abuse or aggression, understood as injury to bodily
inviolability.42
The first jurisprudential consideration of the patient’s
autonomy establishes that ‘‘every adult human being in
his/her right mind has the right to determine what is to
be done with his/her own body’’. The historical quote by
Judge Cardozo is indicative of the legal reasoning that takes
autonomy from political philosophy to clinical medicine.21
Acknowledging the right to privacy and confidentiality
occurs in parallel, more or less at the same time, though
through different ways.42
For some judges, the jurisprudential origin of IC reflects
a situation of normative void that fostered the physician’s
impunity. The IC contributes legal language and rationality,
that is why it is (in procedural terms) more comfortable than the expert’s report. On the other hand, some
physicians claim that the jurisprudential origin of IC represents a failure of the traditional self-normative mechanism.
To them the IC is seen as an aggression that interrupts
the good historical relationship between physicians and
judges.19,20
Autonomy as a principle of bioethics
The boom of bioethics is due to a social climate of distrust in the traditional powers. In the United States, the
cradle of bioethics, the historical context is marked by
the Vietnam War and the Watergate scandal.43 The exposure of some regrettable episodes with respect to research
on humans unleashes social alarm. From the Nuremberg
Code (1947), the Declaration of Helsinki (1964) and the
Belmont Report (1978) a new applied ethics emerges:
bioethics.44,45
Bioethics studies human conduct in biomedicine in view
of moral values and principles.46 It is multidisciplinary and
it aspires to have an influence on the different strata
of medical ethics (deontological, professional and personal strata).46 The principles of autonomy, welfare, justice
and non-maleficence became the essential premises of
healthcare medicine.44 In operative terms, bioethics can
prioritize the principles or focus on the methods and their
consequences.45
To bioethics, the autonomous individual ‘‘acts freely in
keeping with a plan chosen by himself, just as an independent government manages its territories and establishes its
policies’’.44 Bioethics turns autonomy understood like this
into a moral requisite of the medical act and proposes IC as
the ideal procedure to ensure it. Since the 1980s, autonomy
has become the leading principle of bioethics, for countless
reasons that involve unexpected paradoxes.
345
Reasons for leading autonomy
Autonomy enjoys huge ideological appeal.47---51 No one wants
to be left behind in the rejection of paternalism. The
problem is that an autonomy that is too powerful denies
the possibility of any forms of residual paternalism, which
can prove useful when the perfect autonomy is impossible or undesirable.48,49 That is why some authors demand
the return of a weak or gradualist paternalism within the
clinical relation, taking into consideration that the current
autonomist model has failed.48,52
Autonomy triumphs because its content is intuitive.38,39
Deciding whether the medical act is respectful of the
patient’s autonomy is easier than evaluating its scientifictechnical rigor or its degree of justice. Autonomy can be
condensed in a few elementary rules, which seem to be conceived to become part of a legal text. However, the apparent
simplicity of these rules conceals, as we will see, enormous
application difficulties.
Autonomy is well-liked because it incorporates a control
mechanism into the traditional clinical relation,20,21 but its
impact on trust is not insignificant; in fact, it is not likely
IC will manage to replace it. In practice, autonomy coexists
with suspicion and can promote defensive medicine.37 It is
usually believed that ‘‘trust is good, but control is better’’.
It does not really happen like this in medicine. Although no
one denies the need for control in clinical relation, trust
within it is essential.
The hegemony of autonomy ultimately reflects the
difficulties existing to reach a consensus on any other hierarchization of bioethical principles.41 In any case such a
dominating autonomy can have negative consequences for
the patient if the probability for justice and welfare ever
become materialize. Although autonomy is not expressly
against them, it can distract the attention they deserve.50
Autonomy as a denial of vulnerability
Today’s present society worships the individual’s autonomy and disregards acknowledgment of their vulnerability.
Today’s coexistence guidelines revolve around the myth of
the autonomous adult, who is eager to maximize his/her
options in a vital trajectory confined to choices and
exchanges. This sociological trend ignores the fact that
human beings are vulnerable upon birth and continue to be
so, to a greater or lesser degree, throughout their lives.53
Autonomy as a free choice
Autonomy understood as freedom of choice among several
available options makes sense in a clinical trial, in which
two treatments are offered, a traditional and an innovating
one. But freedom of choice is more unlikely in healthcare
medicine, in which there are many simultaneous processes
with multiple people in charge. The weight of choice is
reduced within a rigid, complex healthcare organization. IC
is an institutional offer rather than a medical one, with little
room for actual individual autonomy.50
346
Limitations of autonomous language
Some physicians do not feel comfortable within legal procedures articulated with cold contractual language. After all,
the autonomist language reflects the philosophical-juridical
origin of IC.21 It is consistent with the existence of contrasting interests, but it is perhaps alien to the physician’s
traditional commitment. Without the need to ignore the
demands of that commitment, some physicians are skeptical about the patient’s capacity for autonomy and do not
feel reflected in the autonomist jargon.51
Difficulties of autonomy outside the original
context
The right to autonomy originates in political philosophy and
it aspires to govern clinical reality. Nevertheless, disease
is not the ideal condition in which to exercise autonomy.21
On the other hand, autonomy looks appealing in the academic debate,49 but it stumbles on obstacles in healthcare
medicine.51 Finally, autonomy originates in a concrete
philosophical-legal tradition, but it tends to adopt different meanings when it operates in different cultures and
traditions.54,55
The autonomy of Spanish legislation
In Spain, the legal recognition of the patient’s autonomy is
recent. The record shows it can be found in the Ley (Act)
14/1986, from April 25, General de Sanidad, and the thirdgeneration rights collected in the Convention of Oviedo,
ratified in Spain in 2000. As a result of the latter, Ley
(Act)41/2002 emerges on November 14, this act is the basic
regulatory law (LBR) regulating the patient’s autonomy and
his/her rights and obligations when it comes to clinical information and documentation.56,57
In its article 2.1, the LBR indicates that human dignity and
the respect for autonomy of the patient’s will and privacy
must guide medical conduct with respect to information and
documentation.56 Even though autonomy is considered the
essence of human dignity, the LBR is based on both in a
separate and explicit way. However, the European Court of
Human Rights and the Constitutional Court link the right to
self-determination with the fundamental right to physical
integrity.58
The LBR regulates the right to information on health, the
right to privacy (understood as confidentiality) and the right
to autonomy. It also regulates, in a more or less detailed
manner, the previous instructions, the medical history and
the discharge summary. It refers to the portfolio of services
and the free choice of physician and center. But it puts special emphasis on the IC turning it into legal requirement of
all medical act56 (Table 1).
Duty to inform and right to consent
The LBR regulates healthcare information (Art. 4), epidemiological information (Art. 6) and information as an IC
requirement (Art. 8). It establishes that verbal information
prior to the IC is precisely the healthcare information.56
J.M. Mellado
This way it indicates that the main purpose of healthcare
information is autonomous decision-making. This appreciation conveys an excessively instrumental view of clinical
information. This vision seems to ignore the prevailing experience in many patients who are in general anxious to know,
but not always willing to decide.
Article 4.1 establishes that healthcare information must
be provided verbally, recording it on the medical history.
The patient has the right to know (a) all the information
available, (b) the purpose and nature of each intervention,
their risks and consequences, and (c) the information fitting
his/her own needs.56 The third criterion seems to be the
most subtle of them all but the existence of several criteria
can make the physician’s work harder and it contrasts with
the closed nature of the forms.
Article 8.2 prescribes written IC for invasive procedures
that presuppose risks.56 However, all the procedures are
more or less invasive and entail some kind of risk. It is likely
for this vague prescription of the LBR to promote generalization of written IC. On the other hand, article 10 indicates
that written IC is especially recommended in procedures of
unprecedented results.56 This warning underscores without
any apprehension the legal-strategic importance of IC that
can lead to misunderstandings.
Article 10.1 establishes that before the written IC, information should be provided about the relevant or important
consequences that the intervention originates with safety
and the possible risks in normal conditions, in conformity
with experience and science or directly associated with
this type of intervention.56 This detailed statement disturbs
physicians and lawmakers because it does not clarify what
are the odds of risk materialization on which informing is
legally binding.59
Article 2.3 guarantees the right to decide among several choices though in practice the patient is usually given
one single option. In any case, the patient cannot choose
a procedure without the doctor’s indication since it would
infringe the principle of scientific autonomy and would be
contrary to lex artis.60 The patient cannot demand an option
not included in the services portfolio available either. Even
though both assumptions limit the patient’s actual autonomy
the LBR does not talk about them in detail.
Patient’s capacity and willfulness
The patient’s right to autonomy is limited by circumstances that prevent autonomy or prioritize other rights.
The patient’s capacity is one of the IC requirements. It is
so established in the LBR, whose article 9.3 provides for IC
by proxy in case of physical incapacity, mental incapacity,
legally modified capacity or situations where the patient is
not of legal age.56 However it does not specify what criteria
should be used for the assessment of such capacity.61
Article 8.1 grants the patient the right to refuse to
receive information.56 However, the patient who refuses to
receive information cannot avoid undergoing IC. In conformity with the LBR, the patient cannot waive granting or
refusing consent. In other words, he/she cannot give tacit
consent.62 This obligation of self-determination contrasts
with the genuine objective of IC: promoting autonomy.
Autonomy, consent and responsibility
347
Table 1 Informed consent in Ley (Act) 41/2002 of November 14, the basic law regulating the patient’s autonomy and the rights
and obligations on information and clinical documentation.56
Definition
Foundations
Indications of verbal informed consent
Indications of informed written consent
Information prior to verbal informed
consent
Information prior to written informed
consent
Information rejection
Revoking the informed consent
A patient’s free, voluntary and conscious agreement, expressed in
full possession of his/her faculties after receiving proper information
so that there can be an action that affecting his/her health (Art. 3).
The patient or user has the right to decide freely, after receiving
proper information, among the clinical options available (Art 2.3)
Dignity of human beings (Art. 2.1). Respect to autonomy of their will
(Art. 2.1)
All acts in a patient’s health environment need to have the free and
voluntary consent of the affected party, once the information
stipulated in Article 4 has been received and they have considered
the choice particular to this case (Art. 8.1). As a general rule, the
consent shall be verbal (Art. 8.2)
It will be presented in writing in the following cases: surgery,
invasive diagnostic and therapeutic procedures and, in general, the
application of procedures that encompass risks or disadvantages with
a notorious or foreseeable negative repercussion on the patient’s
health (Art. 8.2)
Patients have the right to know all the information available, except
for the cases excluded by the Law (Art. 4.1). It shall be provided
verbally recording it in the medical history (Art. 4.1). The
information includes, at least, the purpose and nature of each
intervention, its risks and consequences (Art. 4.1). The patient will
receive the information in an understandable manner and based on
their needs and it shall help them make decisions (Art. 4.2)
Enough information about the application procedure and its risks
(Art. 8.3). Relevant or important consequences that the intervention
originates when it comes to safety (Art. 10.1.a). Risks associated
with the patient’s personal or professional circumstances (Art.
10.1.b). Probable risks in normal conditions, according to experience
and the state of science or those directly associated with the type of
intervention (Art. 10.1.c). Counter-indications (Art. 10.1.d)
When the patient explicitly expresses his/her wish not to be
informed, such will shall be respected without detriment to
obtaining his/her prior consent to the intervention (Art. 9.1)
The patient can freely revoke his/her informed consent in writing at
any time (Art. 8.2)
Article 8.5 allows the patient to revoke the consent
granted, but article 21.1 warns that refusing the procedure
offered can lead to forced discharge. Although it mentions
the possibility of offering alternative procedures, the LBR
does not detail the conduct that should be demanded from
the physician when the patient does not grant his/her consent. It is paradoxical that a law that is meant to ensure the
patient’s autonomy pays so little attention to the rights of
disagreeing patients.
provide alternatives for disagreeing patients. In short, they
must make one decision after the other, gauging their possible medical-legal repercussion in all of them. We should ask
ourselves whether the importance the law attributes to the
physician’s own judgment is compatible with promoting the
patient’s autonomy, or whether it reinforces the validity of
traditional paternalism.
The reach of health legislation
The importance of medical judgment
The LBR grants a determining role to the physician’s own
judgment.56,57 The physician must decide if he/she is to
guarantee the information or just contribute to it. He/she
must assess whether the patient understands and what risks
he/she should know. They must decide how much time in
advance to inform and whether it should be done in writing
or not. They must know when the IC can be omitted and
The patient’s autonomy is regulated by many other State
and autonomic laws, in a context of rapid expansion
of health law, marked by doctrinal and jurisprudential
controversies.63 On the other hand, acknowledging rights
without the provision of the necessary resources to ensure
their exercise can be deceiving.63 In any case the overabundance of detailed rules in an environment as changing as
health environment increases the probabilities that they will
soon be obsolete.63
348
Table 2
J.M. Mellado
Informed consent in the medical deontological Code of the Collegiate Medical Ogranization.64
Definition
Foundations
Indications of the information
Content of the information
Indications of written consent
Information rejection
Consent rejection
The physician shall respect the patient’s right to decide freely, after
receiving proper information, about the clinical options available
(Art. 12.1).
Respect human life and the person’s dignity and look after health
(Art. 5.1). Understanding and trust is required between the physician
and the patient (Art. 8.2). The patient’s convictions shall be
respected (Art. 9.1). The physician shall act with gentleness,
correctness and tact while being respectful of the patient’s privacy
(Art. 9.2). Information is not a bureaucratic act, but a clinical one
(Art. 16.1)
It is the physician’s duty to respect the patient’s right to be informed
at each and every stage of the medical process (Art. 12.1). The
physician shall offer an honest, proper explanation of their mistakes
(Art. 17.1)
The information shall be enough to make decisions (Art. 12.1). It
shall be conveyed in an understandable manner, with veracity,
impartiality and prudence (Art. 15.1)
When the measures proposed presuppose a significant risk for the
patient, the consent shall be obtained in writing (Art. 16.2)
The physician shall respect the patient’s right not be informed
recording it in the medical history (Art. 15.2)
The physician shall respect the patient’s partial or total rejection of
a diagnostic test or treatment. The patient shall be informed in an
understandable, precise manner about the consequences that can
result if they insist on their refusal, keeping record in the medical
history
Autonomy of deontological code
The rights linked to the patient’s autonomy are also
described in the Deontological Code (DC) though in a peculiar way.64 The DC, a legal prerogative of the Organización
Médica Colegial (Collegiate Medical Organization), contains
ethical rules inherent to the practice of the medical profession. Because the level of diligence that should be demanded
from the physician is uncertain and hard to judge from out
of the profession, it is accepted that professionals should
define it themselves before society65---67 (Table 2).
Deontological code and Hippocratic tradition
The DC currently in force, published in 2011, declares that
it is in favor of health-care quality and continuous improvement. It defends self-regulation and admits to be in debt of
the historical service vocation toward patients and society.
It points out that altruism, honesty, veracity, empathy and
loyalty define the good doctor and promote the patient’s
trust.64 This vocabulary has elements from the traditional
clinical relation --- rich in human touches while portraying a
slightly idealized image of today’s physicians.
Deontological code and bioethical principles
The DC assumes bioethical principles but will not mention
them. Welfare is implicit in the respect for life. Nonmaleficence underlies in avoiding harm. Justice is present
in the prohibition of any kind of discrimination. Finally,
respect for autonomy is recognized in the defense of the
patient’s dignity, decisions and convictions. In any case,
information and the achievement of consent are deontological precepts linked to acknowledging the patient’s dignity,
not their autonomy.
Deontological code and legislation
Successive versions of DC are getting longer and longer all
the time showing the growing complexity of medicine. The
DC recognizes the legal system, but it is not a law. It aspires
to improve assistance, while the law intends to regulate it.
The DC is binding and failure to comply with it can be considered an indisciplinary act. However, it has little punitive
power. It manifests its will to fight against the laws that
oppose its precepts. It describes the medical act as a lawful act. It turns medical duties into deontological precepts.
It insists on duty, responsibility and quality, but it does not
mention excellence, professionalism or lex artis.64
The DC indicates the obligation of informing and obtaining consent, but it does not mention the legal procedure
intended to comply with such precepts. The DC establishes
that the patient must be provided with the information
necessary to make decisions, just as the LBR stipulates. However, the DC puts emphasis on the need to inform gently and
carefully, and it opposes the excesses that the law might
embrace. It warns that consent must be verbal and never
bureaucratic, stressing the need for written consent when
there are significant risks, just as the LBR does.64
Autonomy, consent and responsibility
DC indicates the need to report the medical errors, something the LBR omits. Consent by proxy and the limits of
consent are described in terms similar to those of LBR. The
DC is right when it points out that the patient’s rejection
should not result in a demand alien to the medical indication. Finally, DC protects the patient’s refusal to receive the
information. However, it is more explicit than the LBR when
it describes the attitude that is to be demanded from the
physician when the patient refuses.64
The importance of deontological code
Some physicians consider that DC is essential while others
just ignore it.65 Some authors suggest that DC is nothing but
a legitimizing discourse intended to protect the physician
from the growing medical-legal uncertainties.68 Few lawmakers question its legitimacy, but forced association and its
scarce disciplinary effectiveness have limitations.69 On the
other hand, DC understood as a mandatory moral code poses
questions. As Victoria Camps claims, referring the problems
of applied ethics to precept codification is not the best way
to underscore the place that deliberation and caution should
occupy in it.45
Autonomy and professionalism
Respect for the principle of autonomy is also an essential
ingredient of the medical profession. This is how US professionalism understands it, whose foundation dates back to
2002.70 Professionalism includes the principle of autonomy
among its guiding principles, along with those of justice and
welfare. On the other hand, professionalism understands IC
as one of the responsibilities linked with the commitment
to honesty with the patient. Both principles and responsibilities of professionalism are shown in the DC, the LBR and
the rest of our legal system. However, professionalism has
the advantage of its global claims and has been endorsed by
over a hundred scientific organizations.
Anyway no code guarantees professionalism.71 The physician seeks excellence with professional acts with the force
of his/her determination from an ethical point of view way
more personal that official. Only with it, is it possible to
show a voluntary and sufficiently vigorous adherence to the
existing legal, deontological and professional rules that are
not always coherent.46
Conclusions
Thirty eight (38) years ago Vaccarino said that the legal
modifications of IC confuse the physicians and stretch out
the forms without improving the patients’ autonomy.72
His observation has not lost an inch of validity, which in
turn reinforces doubts about the feasibility of autonomy
and the consistency of its rules. It is undeniable that the
notion of autonomy has a credible core that deserves all
of our respect,29 even though it does not enjoy unanimous
approval.33 But around this powerful central idea there is
a weaker, more questionable incidental plot that is usually
affected by its relation with clinical reality. We will go back
to this point in the second part of this article, where we
349
will also analyze the legal consequences of violating the
principle of autonomy.
Ethical disclosures
Protection of people and animals. The authors declare that
no experiments with human beings or animals have been
performed while conducting this investigation.
Confidentiality of data. The authors confirm that in this
article there are no data from patients.
Right to privacy and informed consent. The authors confirm that in this article there are no data from patients.
Conflict of interests
The authors declare no conflict of interests.
Acknowledgements
I wish to thank Mr. Ángel Pelayo González-Torre, PhD in Philosophy of Law at the Universidad de Cantabria Law School,
from whom I borrowed many of the ideas included in this
paper and to whom I owe all my interest in this topic. I also
wish to thank Leyre Elizari Urtasun, Professor of Civil Law at
the Universidad Pública de Navarra who generously helped
me during the editing process of editing and proofreading of
this manuscript.
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