Informed consent in veterinary medicine: legal and medical perspectives in Italy

doi:10.4236/ojas.2011.13017

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Vol.1, No.3, 128-134 (2011)

doi:10.4236/ojas.201 1.13017

Open J ournal of Animal Science s

Informed consent in veterinary medicine: legal and

medical perspectives in Italy

Annamaria Passantino, Valeria Quartarone, Maria Russo

Department of Veterinary Public Health, Faculty of Veterinary Medicine, University of Messina, Polo Universitario Annunziata,

Messina, Italy; passanna@unime.it

Received 5 July 2011; revised 20 August 2011; accepted 3 September 2011.

ABSTRACT

During the last four decades the doctrine of in-

formed consent (IC) has become a legal stan-

dard and an essential component of ethical

guidelines in medicine, due to its relevance for

basic human rights such as autonomy and re-

spect of dignity. Over the last few years, this

legal formula has gained importance in veteri-

nary medicine, thereby influencing the everyday

activities of the veterinary practitioners. This

paper briefly describes the ethical and legal

background of IC in Italy and examines how it

relates to the practice of veterinary medicine,

considering the change in social sensibility to-

wards animals. It also outlines the discussion

that should take place between Veterinarian and

client before a planned procedure.

Keywords: Informed Consent; Veterinary Medicine;

Professional Duty; Law; Ethics; Veterinarian-Cli ent

Relationship; Animal

1. INTRODUCTION

In recent years, patients’ consent to medical treatment

has particularly attracted the attention of legal doctrine

and law, becoming the object of continual research and

various interpretations and becoming so relevant as to

gain independence from medical duty as a whole.

From a paternalistic perspective, when the physician

was the sole depository of medical secrets and therefore

the only one who could make decisions, physicians and

patients have moved on to a new relationship as col-

laborating peers [1].

The principle of informed consent (IC), in fact, re-

flects the concept of autonomy and self-determination [2]

of a person requiring and requesting specific medical

and/or surgical intervention. The theory of autonomy is

defined as self-governance or self-rule, a capacity of

people to reflect and choose, and freedom to express

individual aspirations and preferences [3].

Such a justification of IC also lies with the fact that, in

most of Europe and beyond it [4], physicians’ ethical

codes see the duty to ask for IC as an expression of pro-

fessional correctness itself [5].

Like physicians, veterinarian have concerns about

client confidentiality, and are troubled by ethical con-

flicts that arise when the interests of patients (chil-

dren/animals) and clients (parents/owners) diverge. How-

ever, since animals are typically treated legally as a form

of property, the ethical and practical problems for vet-

erinarian have substantive differences from those faced

by physicians. From a legal perspective, the confidential

relationship presumed between physicians and patients

does not always explicitly apply to veterinarian and their

clients.

Nevertheless there are circumstances where confiden-

tiality requirements are explicitly waived to protect pub-

lic or animal health. For example, the Italian Principles

of Veterinary Ethics indicate that a doctor of veterinary

medicine has an obligation to protect the privacy of cli-

ents, but make an exception if a veterinarian is required

by law to reveal confidential information, or if it be-

comes necessary to protect the health and welfare of an

individual, animals, and/or others whose health and

welfare may be endangered.

Relating to IC, veterinarians have a rather unique po-

sition, because the law does not oblige them to have the

patient-owner sign a document like in human medicine

[6]. A veterinarian’s only obligation is of a moral kind.

2. BASIS OF INFORMED CONSENT

IC is the process of obtaining the permission of the

patient to have an opportunity to decide about his/her

health care. This definition originates from the legal and

ethical right of the patient to retain autonomy and from

the ethical duty of the physician to involve the patient in

health care decisions.

A professional and his/her client are bound by a con-

A. Passantino et al. / Open Journal of Animal Sciences 1 (2011) 128-134

129

tract: the latter applies to the first for a professional ser-

vice and, from the time the former accepts, he/she is

obliged to the client as to the use of certain means, not as

to the outcome.

The risk of missing the target will lie with the client.

Along with this main obligation, the professional is

bound to fulfill secondary obligations. Italian law on

contracts (article 1175 of the Civil Code) enforces the

obligation to behave “according to the rules of correct-

ness”: a specific application of this principle is the pro-

fessional’s “duty to inform”.

Actually, clients of nearly all professions, or better

creditors of professional services, must, to a certain ex-

tent, make choices that involve weighing costs and

benefits, which may be complex and hard to understand.

To make decisions, they have to rely on their general

learning and on correct information from the profess-

sional.

Especially in the medical profession, IC cannot be

done without, but to this day it is hard to define, stating

its limits and range, pointing out the multifarious situa-

tions in which it becomes relevant [7].

A conscious person, in full possession of his/her men-

tal faculties, will not have to passively undergo any

medical treatment (diagnostic tests, therapy, surgery,

etc.); this concept derives from the constitutional prince-

ple of the inviolability of personal freedom and the right

to health that produce the legal claim to self-determina-

tion and the refusal of all illegitimate interference.

In fact, in according to articles 13 and 32 of our Con-

stitution, the valid consent of the person in question is

necessary, and he/she shall give it only after receiving

appropriate information and sufficient elements to

evaluate the treatment he/she will have to undergo and

the consequent hypothetical risks.

Clearly, IC involves the patient’s participation,

awareness, information, freedom to choose and decide.

Consent is valid after previous complete information:

a physician is obliged to supply the indispensable ele-

ments to inform the patient sufficiently about the kind of

treatment, the therapeutic alternatives, the aims, the

chances of success, the risks and side effects [8].

IC includes not only the important and fundamental

autonomy of the patient to decide, but also the essential

objective element, that is, information. The expression

IC has simply been transposed in Italian and approxi-

mately translated in an ambiguous fashion into “con

senso informato” when really it should be referred to as

“informazione per il consenso” (“information for con-

sensus”) not only to respect the concept but, surely, for a

more correct deciphering and a more precise interpreta-

tion related to the numerous concepts it presupposes and

implies. Information and consent may be viewed as the

two sides of the same coin; in fact Mallardi (2005)

writes that “ […] on the one ha nd, having obtained con-

sent, following correct and sincere information inter-

preted and deciphered as an important phase and an

essential indicator of correct, scrupulous medico-pro-

fessional procedure and, on the other, the consensus

itself conceived as a duty aiming at the maximum respect

of the rights to self-determination, independence and

autonomy of the patient”.

The jurisprudential and doctrinal debate, arising in re-

lation to the IC, must not turn it into just another bu-

reaucratic performance or a conflict in the physic-

cian-patient relationship, or reduce it to a formality, for

the physician to protect himself against a potential law-

suit, but must be seen as a moment in the fundamental

therapeutic alliance between patient and physician,

which alone allows them to face a disease correctly.

The ratio in the request for IC must, therefore, be

identified in the determination to promote autonomous

health decisions, which has been left aside since the time

of Hyppocrate’s philosophy, which acknowledged that

physicians had the duty and right to tell nothing to the

patient about his/her health conditions and the health

treatments he/she was undergoing ([…] reveal nothing to

the patient about any event to come […]), both to avoid

“extreme measures” from the patient and to guarantee

the physician’s prestige and authority [9,10].

3. INFORMED CONSENT IN ITALY

IC in a veterinarian-client relationship (VCR) is vastly

different from IC in a medical doctor-adult human pa-

tient relationship; where in a veterinarian-client-patient

relationship (VCPR), the patient is not capable of mak-

ing a decision for him or herself. By contrast, in a rela-

tionship between a medical doctor and an adult human

patient, the patient can make the decision him or herself.

Veterinarian-client IC is not based on the principle of

individual autonomy, since it expresses the subject’s

self-determination, which the animal species is not en-

dowed with.

The IC paradigm for human beings is in fact practi-

cally inseparable from its reference to autonomous moral

subjects [2,11]. Since veterinary practice deals with

non-autonomous moral patients, the reference to consent

has a different meaning. In veterinary medicine, where

no rule of law obliges the veterinarian to obtain IC mak-

ing it a sanitary service (with the exception of Ministe-

rial Circular no. 14 of 25 September 1996 on Good prac-

tices of Clinical Experimentation of veterinary drugs on

animals), and informing the client-owner is a duty con-

nected with Good Practice (Code of Good Veterinary

Practice of the Federation of Veterinarian of Europe,

approved by the Federazione Nazionale degli Ordini

A. Passantino et al. / Open Journal of Animal Sciences 1 (2011) 128-134

130

Veterinari Italiani [FNOVI], Jan.29, 2005) and the Italian

Ethical Code of rights and responsibilities of veterinary-

ian, and on the other hand—justified by the ever-in-

creasing technicalities and specialization of the veteri-

nary profession—represents a form of certified qualifica-

tion of the performances offered by the Veterinarian.

In fact, article 29 of the Italian Ethical Code (Duty to

inform and informed consent in veterinary practice)

states that “The Vet, on undertaking contractual respon-

sibilities, is bound to inform his client clearly on the

clinical situation and the therapeutic solutions.

The Vet mu st inform exactly o n the risks, the costs and

benefits of the different and alternative diagnostic and

therapeutic routes, as well the predictable consequences

of the eventual decisions. On informing the client, the

Vet will ha ve to consid er h is/her degree of understanding,

in order to allow them to give full approval to the diag-

nostic-therapeutic proposals.

Any additional information required by the customer

must be satisfied.

A Vet must also answer all investigations on preven-

tion matters from the public at large.

The Vet is bound to inform his/her client on the pre-

dictable suffering and pain of their animal and on the

presuma ble du rat i o n of the professional operati on.

It is the Vet’s duty to communica te to a client the need

to perform particular actions, in order to avoid suffering,

pain or prolonged illness in the patient animal”.

It being understood that consent is necessary, we must

say that the choice of the treatment lies with the Veteri-

narian, because, for his/her professional skills, technical

and scientific knowledge of medicine, he/she stands on a

higher level than the owner of the animal. Once the

treatment has been chosen, the veterinarian must propose

it to the client, who might not accept it. In this case, the

veterinarian is free of any professional obligation and is

not obliged to carry out any treatments that the client

may considers suitable, but which are against the physic-

cian’s “science and conscience”.

Conversely, if the veterinarian thinks that more than

one treatment is suitable, the ultimate choice lies with

the client who has ultimate responsibility for the animal

and for decisions about its welfare.

In veterinary medicine, getting this IC typically means

the veterinarian explains both the risks and benefits as-

sociated with a specific medical or surgical intervention.

IC is an important concept in the VCPR because it is

part of what defines the boundaries of that relationship.

In addition to defining how the veterinarian and the cli-

ent together make decisions regarding the care of the

patient, IC also defines how the veterinarian deals with

the client. If the veterinarian does not give the client

enough information to allow the client to give IC, the

veterinarian has failed to uphold one of his or her duties

to the client and to the patient. IC is rooted in the idea of

protecting both the client and the veterinarian.

4. OBTAINING INFORMED CONSENT

Obtaining IC from clients is a crucial element of ethi-

cal and professional communication in veterinary medi-

cine. In non-emergencies, obtaining IC requires the vet-

erinarian to discuss with the client the clinical issues, the

alternatives to the proposed diagnostic or therapeutic

intervention (in addition to the benefits and risks of each

option), and the possible adverse effects and long-term

care associated with each option [12]. In addition to the

standard “clinical” elements of this conversation, the

veterinarian should attempt to assess the client’s prefer-

ences for and understanding of the choices before him or

her.

Having first said that the quality and quantity of the

information supplied by the Veterinarian to his/her client

does not depend on its eventually being formalized or

not, it is however highly important, if one thinks that

incorrect information might be cited in a lawsuit.

However, there are different evaluations of the “de-

gree” of information to be offered to the client-owner.

Information must therefore be as complete as possible,

true and objective.

In particular, it must comply with the following prin-

ciples:

 Information must be proportional to the importance

of the procedure or treatment method;

 Information, though complete, must be limited to the

elements that a client can understand;

 Information, though objective, must leave aside

purely scientific aspects.

More specifically, the entries in a clear and complete

IC form will include diagnosis, therapy (medical and/or

surgical), etc., as shown in Table 1.

Those suggestions, however, do not limit the possibil-

ity to introduce further data that might be necessary in

specific cases.

One aspect, which the veterinarian must take into

consideration before informing his/her client of the

costs-benefits of a treatment or procedure he/she deems

necessary for an animal to undergo is the duty to inquire

about the destination of the animal.

So, for example, when the veterinarian diagnoses

pyometra in a bitch, on advising surgical hysterectomy,

he/she will have to inform the owner that such a treat-

ment, though promising good chances of recovery, will

compromise her reproductive function forever. In the

absence of such information, the owner might report the

veterinarian for its incompleteness, in case he/she could

prove that a different decision would have been taken on

A. Passantino et al. / Open Journal of Animal Sciences 1 (2011) 128-134

131

Table 1. Kind of information offered to the client-owner5.

Diagnosis

Description of the diagnostic course

Benefits

Risks

Prices

Moral and other implications of the course chosen

Diagnostic hypothesis, if any, and differential diagnosis

Therapy (medical or surgical)

Description of the recommended surgery and reasons for its choice

Benefits

Risks

Materials used

Complications and consequences of the therapeutic procedure from

the point of view of both man and animal

Prices

Therapeutic alternatives or no operation

Difficulties in dealing with the patient or convalescent

Ethical or other implications of the therapeutic course

Unexpected events taking place during the therapeutic deed, where

it is impossible to communicate with owner

Anaesthesia

Proposed or alternative anaesthesia

Preliminary tests

Benefits

Risks

Costs

Ethical implication

the basis of complete and correct information.

A practical aspect of the IC form relates to the possi-

bility of including the costs of treatment among its en-

tries. Although news about the costs make information

complete, they should be kept separate from the rest,

because, for their purely economic value, they represent

a proforma invoice on the veterinary service; on the con-

trary, the aim of IC is informing the client of the costs

and benefits of a certain service.

As regards the forms the expression of consent can

take, unlike in human medicine, where consent must be

given in writing, in veterinary medicine the written form

is not obligatory, although there is a practical tendency

to identify IC with a written form.

Having said this much, we can distinguish between

various ways to express consent:

1) Tacit or implicit consent, when the subject’s will is

inferred from his/her behavior, not from an explicit

statement.

2) Explicit consent, when someone’s will is expressed,

either in writing or orally.

There being freedom as to form, we can usefully con-

sider whether it is advisable for a Veterinarian to use

written forms.

Obtaining an IC form for any service a veterinarian

may perform is surely unthinkable. Transferring what is

the custom in human medicine, we can distinguish be-

tween:

a) routine activities (e.g. vaccination), to which im-

plicit or oral consent is sufficient;

b) extra-routine activities, or those which may pro-

voke irreversible consequences (i.e. euthanasia, castra-

tion, caudectomy, horn-abrasion, amputation of a leg) or

a risk (surgery), for which IC in writing is advisable,

though not necessary.

In box 1 we propose a facsimile.

This facsimile consent form includes the name and

address of the client (owner) and the name, species,

breed, sex, and date of birth of the patient.

Additionally, it should include a clause indicating that

the person signing the form is the legal owner of the

patient and has the authority to consent to treatment.

Following that clause, another clause has spaces to iden-

tify the veterinarian, the veterinary hospital or office,

and the treatment(s) being administered to the patient.

Next is a clause indicating that the client has been in-

formed of the possible risks and complications of the

treatment, and indicating that the client is aware that

unforeseen problems may arise which require further

treatment. Then, there is a clause which authorizes the

use of anaesthesia or pain medications as needed before

or after the procedure(s). After that, a sentence indicates

that the client is aware that other personnel may be re-

quired in order to assist the veterinarian. Finally, the

signature lines are provided for the client and/or a person

acting as an agent on behalf of the client.

When the client signs the document, he/she declares

that he/she has understood the risks and benefits. By

giving IC to a procedure or treatment, it is assumed that

the client both read and understood all of the terms in the

statement. Once IC has been given, the patient-animal

may be treated according to the conditions listed within

the statement.

In the case of oral consent veterinary professionals

responsible for communicating with clients must be sen-

sitive to cultural differences for it to be satisfactory.

They should be alert to the possibility that individual

words may carry distinct meanings in different regional

dialects of the same language. Further, there is the po-

tential for two-way prejudice (veterinarian versus client

and client versus veterinarian) based on race, gender,

ethnicity, age, sexual orientation, religious or spiritual

beliefs, social status, economic status, or literacy level.

Conflict in these situations is nearly always communi-

cated nonverbally; thus, veterinarians should be vigilant

in observing any evidence of client discomfort or the

possibility of being misunderstood.

The emergency setting can place several constraints

on the procedure of obtaining IC. In emergency situa-

tions, where there is often insufficient time to establish

rapport with the client and/or easily to explain the com-

A. Passantino et al. / Open Journal of Animal Sciences 1 (2011) 128-134

132

plicated medical condition of the animal, the veterinarian

should be truthful, exercising care and flexibility.

In settings involving the communication of bad news,

especially when there is no appropriate biomedical re-

sponse, the fundamental skill needed is empathy [13,14].

In fact, expression of empathy, if appropriate, can en-

courage the client to maintain realistic hope about the

bad news.

The veterinarian, like the trained medical professional,

provides only the information that is perceived to be

required and asks for the client’s trust and approval of a

medical plan that is outlined as quickly as possible. For

example, the veterinarian may briefly inform the client

on the life-saving therapies, the probable long-term out-

come from the medical condition, the cost associated

with the immediate medical plan, and in extreme cases

(severe mitral valve endocardiosis, metastatic mammary

carcinoma, etc.) the option of euthanasia.

Fallowfield & Jenkins (2004) [15] suggest that the

way in which bad news is delivered can have a signifi-

cant impact on the VCPR, decrease the stress for the

deliverer of bad news, and improve several important

outcomes from the receiver’s perspective.

5. INFORMED CONSENT AND DUTY

A Veterinarian’s duty regarding IC is two-fold. A Vet-

erinarian has a duty to inform the client and obtain the

client’s consent. The legal approach to establishing this

duty is pragmatic. Although the client has the right to

refuse, it is recognized that the Veterinarian possesses

more information and, as a consequence, more power to

control the circumstances under which the two parties

meet. In addition, the Veterinarian has a duty to respect

and promote the animal-patient’s best interest. As such,

it is the Veterinarian who is held to a higher standard and

thus a greater duty. On the basis of this consideration,

professional practice standards should encourage a Vet-

erinarian to bring up the issues outlined in Table 2.

Among veterinarians, it is widely held that acquiring

IC means protecting themselves from a legal point of

view. Written consent does not guarantee this. A signed

consent form may supply evidence that consent was

given, but not that counselling was necessarily sufficient,

appropriate and not negligent.

Some IC forms that are used in the veterinary field

contain clauses that exempt them from responsibility for

surgery carried out without any previous diagnostic tests.

In truth, such a form, though signed by the client, can

never protect a Veterinarian from non-voluntary respon-

sibilities, caused by negligence (culpa in omittendo),

imprudence (culpa in agendo), inexperience (culpa in

adempiendo), or breach of laws, regulations, orders and

disciplines [16].

Table 2. Information to be Disclosed During Discussion of

Consent.

1. Results of pertinent diagnostic studies

2. Probable outcome of surgery

3. Likely benefits of surgery

4. Explanation of what surgery will entail

5. Probable complications

6. Temporary complications (e.g. pain, infection) and therapeutic

steps to correct them

7. Permanent results and complications (e.g. paralysis, plegia)

8. Other risks that are reasonably foreseeable

9. Reasonable alternatives to the proposed procedure

An IC form can be used as evidence when a lawsuit is

brought on the charge of missing, incomplete, incorrect

or untrue information. However, such a form could eas-

ily prove that the veterinarian has unexceptionably in-

formed the owner, both from a qualitative and a quanti-

tative point of view, but it could also become ruinous, if

it proved the veterinarian has rashly omitted some in-

formation.

So, IC acquires a legal value only if it can prove that a

veterinarian, though using diligence, caution and skill,

and complying with laws, regulations, orders and disci-

plines, has not hit the expected target for other reasons

(either because the ordinary risks and dangers the client

had been informed of have actually come about, or be-

cause the fortuitous or unforeseen events inherent in any

medical activity have taken place).

6. CONCLUDING REMARKS

The ever-growing importance attributed to IC is proof

of a desire for quality in the physician-patient relation-

ship, because it puts the patient's rights first, and then the

physician’s duties.

We must remember, however, that drawing up a form

and having it signed does not in itself exempt a physic-

cian from legal and/or disciplinary responsibilities, while

real and concrete information given to the patient and

the consequent concession of the necessary IC can.

In the VCPR, the veterinarian’s role is crucial: al-

though in the case of surgical treatment to be carried out

on the animal, he/she is not the only one who can decide

in the process that leads to a shared and responsible

choice, he/she is the one charged with the greatest re-

sponsibilities, on account of his/her scientific knowledge

and skills [17].

All this must be connected with a precise duty to in-

form clients of the negative consequences of some of

A. Passantino et al. / Open Journal of Animal Sciences 1 (2011) 128-134

133

their behavior to animals.

Openly accessible at

Although there are no specific norms on the matter,

the Italian veterinarians could keep pace with the new

European ethical principles. This is the trend of the Code

of Good Veterinary Practice with the purpose of setting

European standards for veterinarians’ ethical and be-

haveioral principles “vets must gain their clients’ trust by

providing exhaustive communication and supplying ap-

propriate information”.

In overview, information takes over the main role, as a

way to solve problems or, at least, make all the people

involved feel responsible, and consequently mitigate

possible conflicts between Veterinarian and their clients.

On the basis of the aforesaid considerations, we hope

legislators will take the initiative to regulate the matter

throughout the country with specific norms, which re-

quire veterinarian to apply for IC not only by the Italian

Ethical Code, but by a special law. At present there are

no such laws.

This would give a greater dignity to patient-animals

and, in line with the national and European rules con-

cerning well-being and protection of animals, would

confirm their status as “sentient beings” [18,19] and

confer moral rights [20].

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134

Box 1. Consent to medical treatment and the related diagnostic tests.

(facsimile)

Date..........................

Owner/Owner’s Agent:.................................................. Mr/Mrs. Surname: .......................................................

Name: .................................................................

Address: ........................................................................Town: .......................................................................

Contact Telephone Number(s): .................................... Mobile: ....................................................

Animal/Herd/Flock ID(*): …………………………. Animal Name: ………………...…………………….

Species: …………………………………………… Sex: Male/Female Breed: .....................................................

Colour: ...................................Age: ............................ Reason for the medical examination:................................................................................................

 Authorizes Doctor .......................................................... and his/her staff to examine and/or treat and/or carry out the diagnostic tests they deem

necessary on the basis of the examination and the related tests.

 Allows them to administer sedatives and/or anesthetics to carry out the necessary instrumental tests, declaring he/she has been informed of the

fact that such tests are not exempt from general complications, even if made with skill, diligence and prudence.

 Reaffirms his/her IC to Doctor........................................, who has clearly explained the reasons for which the aforesaid treatments and/or tests are

necessary, also illustrating the risks of the potential contraindications, complications and/or reactions.

 Confirms having read and perfectly understood this authorization form, for carrying out medical treatments and diagnostic tests on the above

identified animal, according to the current norms.

 At the time of the release of the animal from the veterinarian’s consulting rooms, the owner will take on the job of scrupulously watching it and

immediately communicating to the responsible Veterinarian any complications or accidents that may have arisen or that can negatively affect the

outcome of the surgery or treatment done.

 The undersigned also declares he/she will fully pay the costs of the veterinary service that is to be done on his/her animal, presumably between a

minimum of .................... Euros and a maximum of ............................ Euros, if no events, not foreseen in the estimate, take place.

 Gives permission for the possible after-death inspection, in case of death of his/her animal.

(*) If the dog is not microchipped, the owner/holder of the animal is informed of his/her obligation to have the animal electronically microchipped,

according to the Law no.281/91.

Date .............................................................

Full signature of the owner/holder to testify information and acceptance .........................................................