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THE PRINCIPLE OF INFORMED CONSENT IN EMERGENCY SURGERY –

EQUIVOCAL SITUATION IN MAKING LIFE-SAVING DECISIONS

Article in Revista Românǎ de Bioeticǎ · July 2015

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 Revista Română de Bioetică, Vol. 13, Nr.2, april - june 2015

THE PRINCIPLE OF INFORMED

CONSENT IN EMERGENCY SURGERY –
EQUIVOCAL SITUATION IN MAKING
LIFE-SAVING DECISIONS
Daniel Timofte*, Lidia Ionescu*, Radu Danila*,
Roxana Maria Livadariu* , Sorin T. Barbu***, Laura Stoica**

Abstract
Informed consent is a vital document that should be obtained from the patient before performing
any manoeuvres, either diagnostic or therapeutic. The principle of informed consent has gained
important juridical interpretations and implications; therefore it has a great influence on daily
medical practice. It is presented as fundamental ethical norm in major medical codes such as
Hippocratic Oath, the Declaration of Geneva and the International Code of Medical Ethics.
Most of the equivocal situations and issues in making life-saving decisions are encountered on
emergency basis. This paper presents legal and ethical considerations regarding the informed
consent for emergency treatment of patients. Medical decisions performed without informed
consent must be dictated by the need to save the patient's life, unequivocally and well
documented.

Key words: Informed consent, emergency treatment, unconscious patient.

Corresponding author : Lidia Ionescu - lidia.ionescu07@yahoo.com

*“Gr.T.Popa” University of Medicine and Pharmacy, Department of Surgery, III-rd Surgical Unit, “St.
Spiridon” University Hospital, Iasi, Romania;
**“Gr.T.Popa” University of Medicine and Pharmacy, Department of Molecular and Cellular Biology, Iasi,
Romania.
***Department of Surgery IV, “Iuliu Hatieganu” University of Medicine and Pharmacy Cluj, Romania

279
 Introduction
The concept of consent for surgical
operations was first time formulated in
a 1957 court ruling in the United
States; later, the term “informed
consent” was coined and put into use
for this type of situations. In the United
Kingdom, informed consent first
appeared in court in 1981. The
principle of informed consent reflects
the concept of autonomy and
decisional self-determination of the
person requesting any medical and/or
surgical interventions. Through it, the
lawfulness of the health assistance will
be maintained and it protects the main
principles of the relationship between
physician and patient: the principle of
honesty, the principle of autonomy and
the principle of respect for persons (1).
It is presented as a fundamental ethical
norm in major medical codes such as
Hippocratic Oath, the Declaration of
Geneva (2) and the International Code
of Medical Ethics (3). This legal
formula has gained important juridical
interpretations and implications;
therefore it has a great influence on
daily medical practice. Informed
consent is a process and not an event.
It includes the following elements:
disclosure,
understanding/comprehension and
voluntariness (4).
This paper will describe a few of
the situations encountered in our daily
practice, which raised many difficulties
regarding the outcomes of our medical
decisions. Additionally, we will
explore some of the discussions that
emerged from these situations, in the
light of the ethical implications of our
decisions, as well as discussing a few
of the medical cases and studies that
enabled the elaboration of the
principles of informed consent. One of
280
the main guiding principles in the
research regarding emergency
operations is the balance between the
level of risk and the possible benefits
of a surgery. This principle can also be
applied to consent-related procedures.
One of the foremost sensitive issues in
healthcare is the provision of
emergency services. Urgency and
crowding are two of the elements that
constitute the delicate nature of
emergency - urgency regards
psychological and physical distress,
when patients are brought in a state of
imminent danger that might threaten
their health and lives, which imposes
their urgent transport to the surgery
department required for tending to
their condition (5).
In the case of emergency admitted
victims who are acutely incapacitated,
it is not adequate to prioritise the
principle of respect towards the
patient’s autonomy against the
principle of informed consent. This
naturally causes a number of concerns
regarding the ethical implications of
proxy consent in situations of
emergency. Things go even more
badly when written consent is required,
a procedure that takes time and further
endangers the patient’s health.
Experimental models have revealed a
range of therapeutic benefits which can
be used to strengthen the moral case
for the justification of randomizing
patients under deferred consent during
a sufficient time window. The existing
risk nevertheless needs to be
acceptable, given the severity of each
injury and the progress of the disease.
In the case of trials regarding waiver of
consent and deferred consent, an
independent safety committee bound
by relevant authorities would decide
how the issue of consent is tackled,
based on the experience of bad
outcomes in trials when the waiver of
consent has been encountered in
various medical areas (6).
Are surgical staffs considering a
nuisance implementation and
introduction of structured informed
consent in daily practice? The
implementation and introduction of
structured informed consent in daily
practice demand considerable
quantities of insufficient consultation
time. Technically, in order to facilitate
structured informed consent, modern
systems may be utilised, such as
computer based tools. Through the use
of computers, the commitment of the
patient can be stimulated, the time of
consultation can be reduced, and there
would be an improvement in the
quality of services. At this moment,
residents and surgeons worldwide are
starting to use these systems for
structured informed consent and most
of them believe that the key for
implementing structured informed
consent is an open mind regarding the
utilisation of software as soon as
possible (7).
There have been numerous debates
on informed consent over the years,
both in terms of patient participation in
medical studies and application of any
medical manoeuvres on patients,
whether in emergency or elective
conditions. Most difficult situations
have been found mainly on patients
requiring emergency surgical
treatment. Although there are many
efforts conducted in order to improve
patient safety by structuring the
services provided, many aspects of the
informed consent are not standardised.
Countries like Australia and UK have
recently introduced and successfully
applied standard informed consent (8).
Unfortunately, the introduction of
these systems in Romania at the
281
present time requires substantial
amounts of money, higher levels of
software preparation for surgeons and
residents and also open minded
patients. While in Europe these
systems are implemented at a small
scale, under few pilot studies, in USA
there is a programme that has been
fully implemented in the daily practice,
iMED, which currently seems to have
a great success. There are many studies
to be conducted that will demonstrate
and ease the introduction of such web-
based interactive programs in order to
implement them on a large scale in
Europe (9).
It is generally accepted that a
surgical emergency is a condition that
acutely endangers the life or health of a
patient and requires immediate surgery
in order to save the life of a patient, to
preserve a patient’s organs or limbs or
to improve a patient’s quality of life
(10). An informed consent is limited to
those procedures made known and
contemplated by the patient at the time
consent is given (11). Informed
consent in emergency medicine is
supposed to include the nature,
benefits and risks of emergency
medical intervention and differentiates
with respect to definite groups of
patients: conscious patients,
unconscious patients and children and
mature minors (12). In order to reach a
correct medical diagnosis and
treatment in emergency situations, the
surgeon might need to assess the
patient’s capacity to provide informed
consent.
The issue of children and the
decisions made by incompetent
parents
Another issue troubles the medical
area of studies: child patients. They are
thought not to have the proper
understanding and knowledge to give
consent regarding the practice of
experimental studies or surveys on
them. This is decided with their parents
if the child is not older than 16. Recent
studies developed on children of
different age shows that their level of
maturity and it’s continuously getting
higher standards and knowledge
regarding decision making and level of
understanding multiple situations (13).
Although it’s clear and proven this
fact, doctors still ask consent to their
parents for participating in studies
without telling the involved children.
This may result in bad decisions from
incompetent parents and dramatic
results during medical practice or
study. That’s an example of errors
made to distract and manipulate the
child that usually has a high level of
intelligence and understanding of the
purpose of the treatment that he will be
subjected to. All these aspects have
been pointed out by Mason and
McCall Smith in their studies (14).
There are also other circumstances
when the emergency exception to the
requirement to obtain informed
consent has limitations. For example,
there are patients that refuse the
specific treatment of a non-
complicated disease, for example the
sclerotherapy for non-bleeding
oesophageal varicose associated to
liver cirrhosis, even if the risks were
explained. But what will the same
physician do when the same patient is
hospitalized for a life-threatening
complication of the same disease such
as bleeding of the varicose with
haemorrhagic shock that gives an
unconscious patient?
Despite the fact that improvements
in the application of informed consent
in medical practice have been attained,
282
there are some studies that underline
that in surgical practice,
implementation of informed consent is
still below expectations. Surgeons or
residents may sometimes overestimate
the competence of the patients in the
decision making regarding the best
medical treatment, whilst patients are
usually misinformed or unaware on the
importance of informed consent, as
will be further presented. Also, the
quantity of information that is expected
by the patients is sometimes
underestimated by the surgeons. On
the other hand, some parts of the
information provided by the surgeons
may not be comprehended by the
patients, especially since patient
comprehension is not routinely
checked in studies (15). There is a
small number of surveys and databases
regarding the informed consent
process, due to economical depository
aspects. Important geographical
dissimilarities in information were
found in preparation of residents for
the informed consent process, as
demonstrated in some studies (16). It is
currently unknown if these
shortcomings of informed consent
process are encountered in Romania.
Patient understanding
Many studies have demonstrated
that a large part of the patients do not
remember much of the data presented
to them throughout the process of
obtaining the patient's consent,
whereas the patient's ability to
comprehend is, very often, perceived
better than it actually is. The patient’s
power of comprehension relies on
factors such as: education, age,
intelligence, locus of control, anxiety
and cognitive function. Also,
researchers have demonstrated that, as
time passes, patient’s recall and
comprehension decrease, while their
understanding strengthens. This
represents one of the negative factors
involved in the process of delivery
informed consent to the patients,
especially in emergency surgery (17).
Patient sovereignty
Informed consent also demands
that patients practise their sovereignty
independently. Still, researchers have
collected data from multiple countries
which revealed that patients would
rather defer or delegate their decisions
to others or that they would rather
make a decision by collaborating with
their system of support. For instance,
Degner and co-authors demonstrated
that up to 59% of patients diagnosed
with cancer that were interviewed
would constantly choose to assign all
or at least some of their medical
selections to other people. Another
aspect to consider is that patient choice
over the importance of obtaining the
informed consent fails to focus on the
process of making decisions, but
instead is more focused on the building
trust between patient and doctor, which
allows the patient to take a "leap of
faith" and submit himself/herself to the
medical procedure. (18).
When the surgeon concludes that a
patient is incapable of providing
consent for an acute care procedure, he
should attempt to locate and obtain the
consent of a family member, if
possible. If a family member cannot be
located and if the physician considers
that the delay in applying the treatment
is harmful for the patient, he should
further proceed with the appropriate
treatment or surgery. The physician
will apply a treatment dictated by the
need to save life, based on
283
consideration of the implied consent
action (presumed or assumed),
according to the Hippocratic Oath, his
specialization and hospital type. In
certain situations such as emergency, it
is considered that the adherence to
therapy is implied, since no human
with ability to consent will decide
against himself (19).
The test procedures regarding the
capacity and competence of patients
when it comes to offering their
informed consent are the following:
first, the patient has to be capable of
comprehending and retaining the
information offered to him/her; second,
the patient has to believe the
information and third, the patient has
to be capable of weighing the
information in order to come to a
decision regarding the upcoming
intervention. The patient is deemed
unable to consent for himself or herself
if any of these three conditions are not
met; in other words, the patient is
“incapacitated”. The new legislation
introduced by the European Parliament
demands a “legal representative” to
offer the consent instead of the patient.
The patient can participate when “the
legal representative has given his
informed consent to the subject taking
part in the trial”, as specified by the
regulation regarding “incapacitated”
patients and, as far as the United
Kingdom is concerned, this is the first
instance in which an adult can offer his
consent of behalf of another adult
person. The “legal representatives”
specified by the legislations for
England, Northern Ireland and Wales
(for minors and adults) and in Scotland
(form minors only) are also described
in the laws (20).
Treatment in emergency situations
is considered appropriate even when
the patient is incapacitated. Court cases
have sometimes tested this: a case
from 1990 has specified that “in the
case of unconscious or incompetent
adults, a doctor will not be acting
unlawfully if he or she acts in the
patient’s best interest”. Furthermore,
“the operation or treatments will be in
their best interests if, but only if, it is
carried out in order to save their lives,
or to ensure improvement or prevent
deterioration of their physical or
mental health.” A patient may also be
deemed incapacitated if he or she
suffers from a psychiatric condition. In
such cases, the provision of proxy
consent is in order, if the patient has
given his/her accord to this at a
previous moment. If this is not the
case, necessity tests are required,
which involve deciding what the best
interest of the patient would be. In
England and Wales, these interests are
decided by the medical profession,
whereas in Scotland it is up to courts to
decide (21). Patients may, in some
cases, by legally incompetent, despite
their being able to make informed
decisions. In these cases, however,
proceeding without consent is
inappropriate, and the physician is
required to withhold any information
that might cause harm to the patient. In
some cases, the disclosure of
information might affect the mental
state of the patient, leaving him or her
incapacitated. Such cases can be prone
to abuse and patient can suffer from
anxiety, which may affect his ability to
consent. If the patient gives up his or
her rights to make a decision, the
situation is that of patient waiver (21).
Generally, the principles and
criteria important for the informed
consent in emergency surgery can be
divided into three subcategories,
between which a balance must be kept.
The principle of equality is the first
284
principle. Its foundation lies on the
idea that every individual has an equal
worth life and stands that the chances
to receive the necessary treatment
should be equal between individuals.
An emergency surgery department that
is based on this concept should
probably operate on the basis of first
come, first served, granting equal
attention to all, without taking into
consideration the intensity of the
treatment needed by the patient, or
even though not prioritising the
surgeries according to the emergency
of the case (22).
The lack of tendency on behalf of
medical practitioners to abandon any
individual that might be fit to receive
surgical treatment may provide
complete support to an equal
emergency surgery appropriate to the
needs of each individual. This
principle is commonly referred to as
the principle of non-abandonment or
the rescue-principle. Still, in order to
perform an efficient use of deficient
resources, the principle of equality in
emergency surgery must not receive
priority, because it is not the optimal
strategy. On the other hand, the
principle of utility means that actions
should be evaluated by their outcomes
and the extension of the outcomes
produced in net benefit evaluation in
comparison to those influenced by
them. In simple words, the principle
refers to creating the greater good to
the greatest number of individuals.
Utilitarianism is in fact the theory
utilised in emergency surgery, to the
extent that medical practitioners try to
utilise the so scarce medical assets as
efficiently as plausible. When
considering which benefits or goods
need to be maximised, the principle of
utility in itself, however remains silent.
For obtaining the best net assistance,
medical practitioners have to have a
proper overview of the benefits that
will be most useful to the case at hand.
For example, emergency surgery
sections might try to provide increased
healthcare improvements for
maximising the numbers of lives
saved, the preservation and restoration
of functions and an overall increase in
the quality of life of the patient (23).
However, in order to maximise the
overall chosen benefits, emergency
surgery may choose that some
interventions for some individuals to
be delayed and in some cases poorer
outcomes may result. If an intervention
yields overall good outcomes, some of
the eventual bad consequences may be
justified in some of the cases.
Emergency surgery faces this daily
because when considering emergency
situations, the assets are limited in
comparison to the needs of the
individuals. As a consequence, in order
to maximise the utility, the necessity of
some individuals will be prioritised to
those of others. Regarding the criteria
selected in order to maximise utility, it
will fall in the hands of the surgeons
and residents treating different
emergency cases.
The principle of justice has a
reflection in one specific criterion,
such as the principle of priority of the
greatest emergency. The one’s
definition of the greatest emergency
depends on the surgeon or resident
vision in this case. Is this patient in the
greatest danger? Does it represent the
most urgent case? Or are the cases with
the smallest likelihood of survival? Or
the cases of uninsured poor patients, or
homeless who end up receiving
emergency surgery because they do not
have any other possibility to receive
medical care? (24).
In emergency surgery, most
285
patients come because the lack of
intervention means certain death.
Correspondingly, the most endangered
case is represented by severely injured
or ill people who have the highest risk
of death next to the patients with a low
likelihood of successful intervention,
cases in which the very life of the
patient is in danger. Following this
guideline, surgeons or residents have
to prioritise intervention over this
obvious disadvantaged group. Still, it
can be very inefficient to concentrate
the entire resources on this type of
individuals with very low chances of
survival, especially with scarce
resources and staff encountered in our
daily practice. Therefore, a
rectification must be performed.
Promoters of this principle often tend
to concentrate on obtaining as few
"avoidable deaths" as possible by
sending only "salvageable patients" to
the emergency surgery room (25).
So, the guiding principle is that
delay in treatment in order to obtain
consent should not affect the patient.
The procedure needs to be lifesaving
as long as the potential harm to the
patient is significant. This principle of
necessity is a form of adequate defence
of any appeal process for medical
treatment in the absence of consent, for
an unconscious patient and when there
is no known objection to treatment.
However, the treatment must not
exceed the required exigencies of the
situation. Medical Good Samaritan is
an unappreciated and unsupported
character in legal texts (26). Our
country follows similar rules in these
cases. Under the laws of Romania, the
physician responds when he does not
obtain informed consent of the patient
or his legal representatives, unless the
patient is deprived of discernment and
the legal representative, the patient’s
next of kin or other person legally
capable of acting on the patient’s
behalf cannot be contacted due to
emergency situation. In this case the
doctor may request authorization to
perform the medical treatment to a
guardianship authority or act without
consent in emergency when the time to
express agreement would endanger,
irreversibly, the patient's health and
life (27).There are cases when multiple
surrogate decision-makers at the same
level are present; for example, three
adult sons of the patient, when the
physician should try to help them
achieve consensus about medical
treatment. In the case of conflict
among members of the same category,
the majority decision is to prevail. A
single brother who disagrees with the
choice made by the other two is free to
file for legal guardianship in order to
contest the decision. Turning to the
courts is, obviously, a complex and
time-consuming process. But what will
the doctor do when the patient’s family
gives no majority? In practice,
physicians should discuss and explain
the patient's family the risks and
benefits posed by the proposed medical
or surgical act and provide them a
basis for leverage. Treatment decisions
for the patient should not, however, be
held hostage to families in dispute, and
the law provides a way for physicians
to proceed with the majority opinion.
Obtaining the patient's consent to
medical care is a legal requirement.
This emergency exception to the
requirement to obtain consent has also
other important limitations dictated by
patient’s condition. Clinicians should
not administer emergency treatment
without consent if they have reasons to
believe that the patient would refuse
such treatment if he or she were
capable (28). For example, Malette v.
286
Shulman (29) gave blood tranfusion to
a patient unconscious, transfusion in
order to save the patient’s life. The
physician ignored the fact that the
patient carried a signed card indicating
that she was a Jehovah’s Witness and
did not want to receive blood
transfusions under any circumstances.
After that, the court found the
physician liable for battery because the
written instructions were “clear,
precise and unequivocal” (30).
Consent in emergency research
Conducting medical research
regarding emergency cases in which
the patient is incapable of offering his
or her informed consent is often a
difficult task. For example, a patient
who is affected by a sudden acute heart
attack is most likely unable to critically
assess the risks and benefits that an
emergency intervention would have on
his health and wellbeing; in such cases
of distress, the informed consent can
only rarely be properly obtained.
The legal framework for informed
consent-related research has suffered a
significant change since May 1st 2004,
when the “Medicines for Human Use
(Clinical Trials) Regulations 2004”
was introduced by the European
Parliament, and the Directive
2001/20/EC in the UK. Although
seemingly remote when it comes to
everyday medical practice, the two
laws are of a definite interest for all
emergency medics and for physicians
who are not even involved in
emergency research. Proper evidence-
based emergency healthcare can only
be provided when good proof is
offered via properly-constructed
clinical studies and surveys. If new
regulations fail to consider the data of
emergency-related research and the
data from clinical well-structured trials
(this failure, for instance, may be the
result of complicated bureaucracy), the
physician’s expertise and experience
might not be properly put into use for
providing quality services or for
improving the existing procedures.
Therefore, any change in legislation
ought to be carefully implemented and
scrutinized, towards not endangering
the quality and reliability of healthcare
services and the effectiveness of the
clinical trials (31).
Sometimes, groups of people
around the world take the matter in
their own hands and decide to conduct
their own experimental studies without
the consent of their subjects/patients.
These kinds of tests and results raise
controversies among the human rights
members and are considered unethical.
An example to sustain this theory is the
case in South Africa on HIV positive
patients who were hospitalised in the
intensive care. Although it was
considered an illegal study, the ethical
committee eventually approved it. The
personnel that conducted the
evaluation defended the cause of it by
respecting the four standards of
research without the acknowledgement
of the infected persons: they could not
get the informed consent but once
patients are entering their program, all
their rights and interests must be
respected and protected by any means.
They voted unanimously for beginning
the program and established that the
research has to take place because of
its major importance for the future
studies and results. A nurse or any
medical trained personnel gave the
subjects medical assistance at their
own homes and they were asked the
approval to enter the study program.
What the patients didn’t know wss that
they could be chosen randomly to get
287
an intervention or participate to group
therapies. Explanations for refusing to
inform the patients about the use of
these methods were also given by the
leading doctors. First of all, their rights
were protected at all time so the
randomization was useless and the
people’s integrity was not harmed.
Even during these treatments, any
subject could refuse to participate
without consequences. Doctors
strongly believed that if they had
changed to standard treatments instead
of resorting to family care, the patients
might have gotten into a depression
and thus would have biased the results
conducted for the study. After
concluding the studies and gathering
the results, the practice involved in
these experiments was considered to
justify the means, thus being valid and
conclusive (32).
Doctors need to distinguish
between providing obvious benefit to a
patient who cannot consent and simply
prolonging the dying or suffering of a
patient who can no longer protest and
who did not accept treatment before
the acute episode. Even though
previous refusal of consent may not be
relevant in some of the cases with
surgical intervention might produce a
satisfactory result. Other special cases
concerning the informed consent in
surgery are those related to unexpected
intraoperative situations. We believe it
is worth mentioning cases we
personally encountered of young
unconscious patients without family,
victim of an abdominal trauma with
important injuries of the colon that
ended in a temporary colostomy. The
saviour gesture will be performed. But
what if due to a misdiagnosis we
discover intraoperatively lesions we
did not know about and whose
resolution involves a colostomy? There
are cases when a surgeon discovers
intraoperative a concomitance of an
unexpected disease, for example, an
ovarian tumour discovered during an
appendectomy for an acute
appendicitis. The physician will
consider that as long as the newly
discovered pathology is not life-
threatening for the patient at that
moment, no other organ will be
removed without informed consent.
Amputation is another delicate
situation; it should always be done by
the surgeon only after the informed
consent is obtained. But there are cases
when, for example, a diabetic patient
without family or guardian is admitted
to the surgery department in septic
shock due to wet gangrene of the leg or
when a unconscious, traumatized
patient needs amputation in emergency
of a limb affected by massive tissue
destruction, manoeuvre that would be
life-saving.
Conclusion
All these unfortunate situations
have significant impact on patient’s
quality of life and that is the reason
why medical decisions performed
without informed consent must be
dictated by the need to save the
patient's life, unequivocally and well
documented. An improvement in the
informed consent on its legal solidity,
completeness and quality can be
provided by structuring its form.
Furthermore, a better structure can
increase patient appeasement and
safety and can protect from high effect
malpractice requests. As a conclusion,
informed consent principles must be
followed in each problematic situation
and the burden of decision can often
fall on the shoulders of surgeons. In
these cases the principles of
biomedical ethics must be used as a
framework that can ease the everyday
practice.

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