**3. General principles**

Ethical theories can be grouped for simplicity into two main currents.

One is **teleological ethics**. Teleological theories focus on the purpose of the decisions taken and on their positive and negative impacts, and assess the consequences of the action [15]. These theories are deductive and pragmatic. Among the best known are John Stuart Mill's utilitarianism [16] and American principlism [17]. The latter is undoubtedly one of the most widespread currents in medical ethics, at least in the United States, and will be discussed below. These theories focus on doing good for each individual, but also for the community.

The second current is **deontological ethics**; this differs fundamentally from the teleological approach in that its focus is not on achieving a good outcome but on doing what is morally right. The deontological approach is based on a series of '*prima facie*' principles; it is an inductive principle focused on processes rather than on the final decision and it refers to the theories of Kant and Habermas [18]. Deontological ethics recognises absolute prohibitions, which admit no exceptions for any reason, override other duties, are fixed '*a priori*' and are unchangeable. However, since conflict may arise between different duties, priorities must be identified in the hierarchy. Thus, a shift occurs from a hierarchy with absolute '*a priori*' duties to an ethics with '*prima facie*' duties, which also requires examination of the circumstances.

Teleological ethics and deontological ethics are two alternative ethical theories that determine the moral good or evil of an action.

The key difference between the two theories is that teleological ethics weighs the good or evil of an action according to its consequences. By contrast, deontological ethics determines the good or evil of an action on the basis of an examination of the action itself. Its vision is based on rules that determine the action.

Application of these two theories to end-of-life care can help to clarify the difference between them. Under the teleological framework, doctors who practice assisted dying focus on the purpose of decisions. They respect the patient's choice to end her suffering when there is no hope of improvement. By contrast, under the deontological approach, doctors may refuse to provide assisted dying care on the basis of the a priori principle that doctors are trained to treat and not to take life. These are two diametrically opposed positions, which require different ethical frameworks.

General principles that state universal values of common morality also contribute to the basic reasoning on medical ethics . Beauchamp and Childress [17] have identified a model consisting of four moral principles that constitute the most common framework for achieving what is 'good' and what is 'right' in healthcare. 'Principlism' is a basic framework because it identifies four fundamental principles that come into play in most medical decisions, across the different medical specialities, countries and continents. These principles do not constitute a moral system or theory, but offer a framework for reflection on the moral problems encountered, and provide a starting point for making a moral judgement and assessing the procedure to be followed. The main principles are:

**313**

*The New Challenges for Medical Ethics DOI: http://dx.doi.org/10.5772/intechopen.94833*

maximise the patient's consent.

subjective interpretation of the patient's 'best interest'.

although effective, could be harmful to the patient.

The principle of *autonomy* refers to liberal thought, which has always emphasised individual rights and freedom of choice as an expression of the individual's free will. The patient is recognised as possessing critical thinking and decisionmaking skills that must be respected. The model that emphasises the autonomy principle aims to oppose and overcome the paternalistic approach that has long dominated the doctor-patient relationship. The paternalistic model was based on an asymmetric relationship between the doctor (acting as a good parent) and the patient, who was treated as a 'child', unable to make decisions because of his lack of scientific and, especially, medical knowledge. This model has been discarded by reversing the patient's role, from a passive one, to that of an autonomous person, capable of self-determination according to the principle of individual autonomy. The principle of autonomy ensures that the patient is involved in the medical decision-making process and protects his right to choose, accept, refuse or stop treatment. This is an absolute right of the individual, even where the refusal or interruption of treatment might cause adverse health consequences or even death. Autonomy implies respect for an individual's physical and mental integrity. A person cannot be forced to receive treatment against her will. The patient cannot be subjected to any physical or mental coercion. The principle of autonomy also underpins the patient's right to accurate and exhaustive information on the proposed treatment. Recognition of this right has led to development of the informed consent procedure. However, for certain specifically identified medical conditions that pose a public health threat, the government has the coercive power to impose treatment; this can occur, for instance, in the case of acute psychiatric patients or highly infectious diseases. However, even in these cases, the dignity of the person must always be respected. To apply these rules, doctors must know the legislation in force in the country in which they work; in any case, they must take all proper actions to minimise the need for coercion and

The principle of *beneficence* states that the patient's well-being is the ultimate goal of care. This principle lies at the heart of medicine, whose mission is precisely to prevent, diagnose and treat illness in order to promote the patient's health. It is a question of proposing a treatment that is proportionate to the patient's needs and whose benefits for the patient outweigh its possible harms. This principle means that doctors may act in the patient's best interest also by refraining from acting and/ or by acting prudently, always from the viewpoint of the benefit for the patient. Traditionally, this principle has been focused on 'objective' good, i.e. the outcome considered to be good by the doctor. However, cultural and ethical developments have gradually led to add to this principle that of autonomy, supporting a more

The principle of *non-maleficence* has been well known to doctors since the time of the Hippocratic precept of *primum non nocere*. Non-maleficence encompasses two key concepts. The first is that of not causing harm to patients, even before doing them good. The second is the need to properly assess the risks and the benefit/risk balance of a treatment, and hence to refrain from prescribing a treatment that,

The non-maleficence principle is reflected in a number of legal provisions regarding wilful medical malpractice, where the patient was intentionally injured, or negligent malpractice, where the harm was caused by negligence, inexperience, recklessness or failure to comply with laws, regulations, orders or standards.

• non maleficence

• justice.


*The New Challenges for Medical Ethics DOI: http://dx.doi.org/10.5772/intechopen.94833*


*Bioethics in Medicine and Society*

**3. General principles**

duties, in order to protect the patient (**Figure 1**).

good for each individual, but also for the community.

that determine the moral good or evil of an action.

procedure to be followed. The main principles are:

• respect for autonomy/the individual

since ancient times, the power imbalance inherent in the patient-provider relationship has required a framework of principles and rules specifying the physician's

Ethical theories can be grouped for simplicity into two main currents.

One is **teleological ethics**. Teleological theories focus on the purpose of the decisions taken and on their positive and negative impacts, and assess the consequences of the action [15]. These theories are deductive and pragmatic. Among the best known are John Stuart Mill's utilitarianism [16] and American principlism [17]. The latter is undoubtedly one of the most widespread currents in medical ethics, at least in the United States, and will be discussed below. These theories focus on doing

The second current is **deontological ethics**; this differs fundamentally from the teleological approach in that its focus is not on achieving a good outcome but on doing what is morally right. The deontological approach is based on a series of '*prima facie*' principles; it is an inductive principle focused on processes rather than on the final decision and it refers to the theories of Kant and Habermas [18]. Deontological ethics recognises absolute prohibitions, which admit no exceptions for any reason, override other duties, are fixed '*a priori*' and are unchangeable. However, since conflict may arise between different duties, priorities must be identified in the hierarchy. Thus, a shift occurs from a hierarchy with absolute '*a priori*' duties to an ethics with

'*prima facie*' duties, which also requires examination of the circumstances.

action itself. Its vision is based on rules that determine the action.

Teleological ethics and deontological ethics are two alternative ethical theories

The key difference between the two theories is that teleological ethics weighs the good or evil of an action according to its consequences. By contrast, deontological ethics determines the good or evil of an action on the basis of an examination of the

Application of these two theories to end-of-life care can help to clarify the difference between them. Under the teleological framework, doctors who practice assisted dying focus on the purpose of decisions. They respect the patient's choice to end her suffering when there is no hope of improvement. By contrast, under the deontological approach, doctors may refuse to provide assisted dying care on the basis of the a priori principle that doctors are trained to treat and not to take life. These are two diametrically opposed positions, which require different ethical

General principles that state universal values of common morality also contribute to the basic reasoning on medical ethics . Beauchamp and Childress [17] have identified a model consisting of four moral principles that constitute the most common framework for achieving what is 'good' and what is 'right' in healthcare. 'Principlism' is a basic framework because it identifies four fundamental principles that come into play in most medical decisions, across the different medical specialities, countries and continents. These principles do not constitute a moral system or theory, but offer a framework for reflection on the moral problems encountered, and provide a starting point for making a moral judgement and assessing the

**312**

• beneficence

frameworks.

The principle of *autonomy* refers to liberal thought, which has always emphasised individual rights and freedom of choice as an expression of the individual's free will. The patient is recognised as possessing critical thinking and decisionmaking skills that must be respected. The model that emphasises the autonomy principle aims to oppose and overcome the paternalistic approach that has long dominated the doctor-patient relationship. The paternalistic model was based on an asymmetric relationship between the doctor (acting as a good parent) and the patient, who was treated as a 'child', unable to make decisions because of his lack of scientific and, especially, medical knowledge. This model has been discarded by reversing the patient's role, from a passive one, to that of an autonomous person, capable of self-determination according to the principle of individual autonomy. The principle of autonomy ensures that the patient is involved in the medical decision-making process and protects his right to choose, accept, refuse or stop treatment. This is an absolute right of the individual, even where the refusal or interruption of treatment might cause adverse health consequences or even death. Autonomy implies respect for an individual's physical and mental integrity. A person cannot be forced to receive treatment against her will. The patient cannot be subjected to any physical or mental coercion. The principle of autonomy also underpins the patient's right to accurate and exhaustive information on the proposed treatment. Recognition of this right has led to development of the informed consent procedure. However, for certain specifically identified medical conditions that pose a public health threat, the government has the coercive power to impose treatment; this can occur, for instance, in the case of acute psychiatric patients or highly infectious diseases. However, even in these cases, the dignity of the person must always be respected. To apply these rules, doctors must know the legislation in force in the country in which they work; in any case, they must take all proper actions to minimise the need for coercion and maximise the patient's consent.

The principle of *beneficence* states that the patient's well-being is the ultimate goal of care. This principle lies at the heart of medicine, whose mission is precisely to prevent, diagnose and treat illness in order to promote the patient's health. It is a question of proposing a treatment that is proportionate to the patient's needs and whose benefits for the patient outweigh its possible harms. This principle means that doctors may act in the patient's best interest also by refraining from acting and/ or by acting prudently, always from the viewpoint of the benefit for the patient. Traditionally, this principle has been focused on 'objective' good, i.e. the outcome considered to be good by the doctor. However, cultural and ethical developments have gradually led to add to this principle that of autonomy, supporting a more subjective interpretation of the patient's 'best interest'.

The principle of *non-maleficence* has been well known to doctors since the time of the Hippocratic precept of *primum non nocere*. Non-maleficence encompasses two key concepts. The first is that of not causing harm to patients, even before doing them good. The second is the need to properly assess the risks and the benefit/risk balance of a treatment, and hence to refrain from prescribing a treatment that, although effective, could be harmful to the patient.

The non-maleficence principle is reflected in a number of legal provisions regarding wilful medical malpractice, where the patient was intentionally injured, or negligent malpractice, where the harm was caused by negligence, inexperience, recklessness or failure to comply with laws, regulations, orders or standards.

The principle of **justice** requires that all people be treated fairly. It is difficult to provide a single definition of justice, as various theories have produced different versions. Egalitarian theories stress the importance of universal access to basic necessities [19]. Libertarian theories affirm the right to social and economic freedom [19]. Utilitarian doctrines require the balancing of the two principles in order to maximise public and private utility [17]. Moreover, the principle of justice includes the concept of distributive justice, which states that resources should be allocated so as to ensure that access to care is not affected by socio-economic, ethnic or other factors which could favour certain sectors of the population to the detriment of others. The problem of resource allocation arises at different levels. For example, a national government decides which share of funding to allocate to finance social and healthcare relative to other sectors such as education, labour, transport. Moreover, the healthcare budget is in turn distributed differently among the different specialties. Thus, in practice, implementing the distributive principle raises complex issues; for instance, to what extent can expensive experimental treatments be justified in patients who have not responded to conventional approaches? Some of these treatments can cost more than €100,000 per year and clearly erode the sums available to treat other patients.

These four principles are not independent of each other. Rather, they interact in all medical situations of varying complexity, engaging in a dialectical relationship which requires their careful balancing. The clinician's art is to fully understand how to best weigh these factors on a case-by-case basis, to reach the most appropriate decision for the individual patient.

#### **4. The decision-making process**

In modern biomedical ethics, the process by which a decision is reached is as important as the decision itself. This is why it is necessary to have a clear approach that takes into account the problems to be addressed and all the persons concerned.

**Figure 2** shows a decision making process according to Jonsen's four box model for decision making which evaluates four fundamental variables: medical indications, patient and family preferences, quality of life and contextual features [20].

The approach proposed here is one example, among the many available, of a framework to guide the decision-making process. The approach is based on a series of questions, which are set out and explained below.


**315**

**Figure 2.**

*The New Challenges for Medical Ethics DOI: http://dx.doi.org/10.5772/intechopen.94833*

pressure from the media?

*Jonsen's four box for medical decision-making.*

the impact of pressure from fellow doctors or hospital managers, for instance in the event of a shortage of inpatient beds. What is the possible impact of

3.What are the values at stake for each of the parties concerned? To answer this question it is necessary to draw up a personalised list of the hierarchy of values at stake, in the specific clinical situation, for the main parties concerned, mainly the patient, but also her family members (clearly where they have a say) and the medical team. For example, in the case of surgery entailing the risk of serious adverse effects and disability, the patient might refuse the surgery if she feels that the degree of beneficence, as perceived by her, is not adequate; the patient might instead wish to retain her current physical status, refusing a procedure that she considers to be invasive and destructive; this because the patient fears that after surgery, she might not recognise herself as the person she was before. On her part, the doctor may feel that the surgery will enable the patient to survive with what the doctor considers an acceptable quality of life (beneficence/maleficence). In other cases, the reverse may happen: the patient and his family members may want the surgery to be performed

### *The New Challenges for Medical Ethics DOI: http://dx.doi.org/10.5772/intechopen.94833*

*Bioethics in Medicine and Society*

The principle of **justice** requires that all people be treated fairly. It is difficult to provide a single definition of justice, as various theories have produced different versions. Egalitarian theories stress the importance of universal access to basic necessities [19]. Libertarian theories affirm the right to social and economic freedom [19]. Utilitarian doctrines require the balancing of the two principles in order to maximise public and private utility [17]. Moreover, the principle of justice includes the concept of distributive justice, which states that resources should be allocated so as to ensure that access to care is not affected by socio-economic, ethnic or other factors which could favour certain sectors of the population to the detriment of others. The problem of resource allocation arises at different levels. For example, a national government decides which share of funding to allocate to finance social and healthcare relative to other sectors such as education, labour, transport. Moreover, the healthcare budget is in turn distributed differently among the different specialties. Thus, in practice, implementing the distributive principle raises complex issues; for instance, to what extent can expensive experimental treatments be justified in patients who have not responded to conventional approaches? Some of these treatments can cost more than €100,000 per year and

These four principles are not independent of each other. Rather, they interact in all medical situations of varying complexity, engaging in a dialectical relationship which requires their careful balancing. The clinician's art is to fully understand how to best weigh these factors on a case-by-case basis, to reach the most appropriate

In modern biomedical ethics, the process by which a decision is reached is as important as the decision itself. This is why it is necessary to have a clear approach that takes into account the problems to be addressed and all the persons concerned. **Figure 2** shows a decision making process according to Jonsen's four box model for decision making which evaluates four fundamental variables: medical indications, patient and family preferences, quality of life and contextual features [20]. The approach proposed here is one example, among the many available, of a framework to guide the decision-making process. The approach is based on a series

1.What are the facts, the circumstances? This question prompts a description of the clinical problem, concurring factors and psychosocial and environmental aspects. The starting point is awareness that the interaction is not with an illness, but with a sick person with a life history, family, affections, job and deep personal, existential and ideological values. Each participant will, in their own way, experience the impact of the decision. Clearly, at the centre of the decision is the patient, being the person that will ultimately make the decision and bear the consequences. The available options should be assessed from a clinical standpoint, considering the likelihood of success of the option chosen. For example, what are the chances that a patient with aggressive cancer will survive mutilating surgery which may have major adverse effects? Besides the purely clinical assessment, the human and emotional costs involved must also

2.What is the 'spontaneous' option? What do the patient, their family members, the treating physician, the nursing staff and the medical team want? What is

clearly erode the sums available to treat other patients.

of questions, which are set out and explained below.

decision for the individual patient.

**4. The decision-making process**

**314**

be considered.


#### **Figure 2.**

*Jonsen's four box for medical decision-making.*

the impact of pressure from fellow doctors or hospital managers, for instance in the event of a shortage of inpatient beds. What is the possible impact of pressure from the media?

3.What are the values at stake for each of the parties concerned? To answer this question it is necessary to draw up a personalised list of the hierarchy of values at stake, in the specific clinical situation, for the main parties concerned, mainly the patient, but also her family members (clearly where they have a say) and the medical team. For example, in the case of surgery entailing the risk of serious adverse effects and disability, the patient might refuse the surgery if she feels that the degree of beneficence, as perceived by her, is not adequate; the patient might instead wish to retain her current physical status, refusing a procedure that she considers to be invasive and destructive; this because the patient fears that after surgery, she might not recognise herself as the person she was before. On her part, the doctor may feel that the surgery will enable the patient to survive with what the doctor considers an acceptable quality of life (beneficence/maleficence). In other cases, the reverse may happen: the patient and his family members may want the surgery to be performed no matter what, even if its positive impact may be minimal or zero (patient autonomy vs. doctor autonomy vs. fair allocation of resources).

