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FEDERAL STATE BUDGETARY EDUCATIONAL ESTABLISHMENT OF HIGHER
EDUCATION
“KURSK STATE MEDICAL UNIVERSITY”
OF THE MINISTRY OF PUBLIC HEALTH OF THE RUSSIAN FEDERATION
DEPARTMENT OF PHILOSOPHY
Lecture in Bioethics
THE MAIN PRINCIPLES
AND RULES OF BIOETHICS
Lecturer:
PhD, Assoc. Prof. of the Dep.
of Philosophy
Zh. G. Simonova
Kursk 2020
OUTLINE OF THE LECTURE
• 1. The Main Principles of Biomedical Practice.
• 1.1. The Principle of Non-maleficence.
• 1.2. The Principle of Beneficence.
• 1.3. The Principle of Respect for Autonomy.
• 1.4. The Principle of Justice.
• 2. The Main Rules of Bioethics.
• 2.1. The Rule of Confidentiality.
• 2.2. Informed Consent.
• 2.3. Truth-Telling.
•
Ethical Dilemmas
DEFINITION
Principle –
1. A basic truth, law, or assumption.
2. The collectivity of moral or ethical standards or
judgments.
DEFINITION
The term “Principlism” belongs to American researchers
K.D. Clouser and B. Gert.
The term itself helps understand that ethical principles are
used as the basis for making moral decisions.
HISTORY OF THE PRINCIPLES
The Belmont Report, 1979 (the report created by the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research) defines 3 key principles by which it is
possible to judge the ethicality of biomedical researches.
These principles included:
• respect for autonomy of the patient,
• beneficence,
• justice.
HISTORY OF THE PRINCIPLES
American scientists Tom Beauchamp and
James Childress in their turn proposed the
Four-Principles approach having added the
principle of non-maleficence to the above-
mentioned key ones.
4 Principles
• non-maleficence
• beneficence
• respect for autonomy of the patient
• justice
4 PRINCIPLES OF BIOETHICS
• Nonmaleficence – Do No Harm
• Beneficence – Do Good
• Respect for Autonomy of the Patient – free-will
• Justice – social distribution of benefits.
THE PRINCIPLE OF NONMALEFICENCE
Primum non
nocere
(First, do no harm)
What does it mean
not to do harm?
Hippocrates (460 BC–370 BC)
THE PRINCIPLE OF NONMALEFICENCE
- Doctors should not intentionally create a
harm or injury to their patients, either
through acts of commission or omission.
- Doctors should avoid negligence (a careless
or unreasonable risk of harm upon patients).
- If harm is inevitable it should be
minimized.
- Medical competence is obligatory.
THE PRINCIPLE OF BENEFICENCE
The word “benefit” can be defined as
something that promotes well-being.
Health benefit can be interpreted as:
• relief of sufferings;
• care;
• prevention of diseases, illnesses, disabilities;
• psychological benefit.
THE PRINCIPLE OF BENEFICENCE
The principle of beneficence – was
formulated in the Middle Ages by
Paracelsus.
This principle means that the
main duty of health care providers
is not only to avoid harming
patients but also to take positive
steps to prevent and to remove
such harm from them (e.g.
vaccination, isolation of patients
suffering from infections disease )
Paracelsus 1493-1541
THE PRINCIPLE OF BENEFICENCE
Paracelsus 1493-1541
Advice given by Paracelsus:
 humane treatment of patients;
 understand the underlying
or psychological origins of any ailment,
illness or disease;
 healing power of a doctor-patient talk
benefitting a patient
THE PRINCIPLE OF RESPECT FOR
AUTONOMY OF THE PATIENT
• A patient as an autonomous agent with a right to
hold views, to make choices, and to take actions
based on personal values and beliefs.
• Patients have the right to weigh the benefits and
risks of alternative treatments, including the
alternative of no treatment, and to select the
alternative that best promotes their own values.
• This principle in connected with the rule of
Informed Consent.
THE PRINCIPLE OF JUSTICE
Justice in health care is usually
defined as a form of fairness.
This implies the fair distribution
of goods in society.
Persons who are equals should
qualify for equal treatment.
THE PRINCIPLE OF JUSTICE
Our society uses a variety of factors
as criteria for distributive justice,
including the following:
• To each person an equal share
• To each person according to need
• To each person according to
effort
• To each person according to
contribution.
THE PRINCIPLE OF MEDICAL
DEONTOLOGY
This principle was introduced into Russian medicine in the
1940s by Professor Nickolay Petrov. He also worked out the
principles of surgical deontology.
The main idea of this principle is that a health care provider
should observe his professional duty taking into account
legal and moral norms.
THE MAJOR RULES OF
BIOMEDICAL PRACTICE
THE RULE OF CONFIDENTIALITY
Both the process and the result of treatment depend on a
patient’s frankness and honesty. Thus, creating a trusting
environment by respecting a patient’s privacy encourages
him/her to be as honest as possible during the process of
communication and collaboration with a physician.
THE RULE OF CONFIDENTIALITY
Everything that a physician hears from his patients
or discusses with them ought to be kept in the
strictest secret.
THE RULE OF CONFIDENTIALITY
The mentioned postulate goes back to the Hippocratic Oath
which reads: “And whatsoever I shall see or hear in the
course of my profession, as well as outside my profession in
my communication with men, if it be what should not be
published abroad, I will never divulge, holding such things
to be holy secrets.”
THE RULE OF CONFIDENTIALITY
In this regard confidentiality is one of the core tenets of
medical practice.
Confidentiality – is one of the rules of Bioethics saying
that the information a patient reveals to a health care
provider is private and has limits on how and when it can
be disclosed to a third party; usually the health care
provider must obtain permission from the patient to make
such a disclosure.
THE RULE OF CONFIDENTIALITY
• The obligation of confidentiality prohibits health care
providers from disclosing information about their
patients’ cases to others without permission and
encourages the providers to take precautions to ensure
that only authorized access occurs.
WMA DECLARATION OF LISBON ON THE RIGHTS OF
THE PATIENT
• Right to confidentiality
• Confidential information can only be disclosed if
the patient gives explicit consent or if expressly
provided for in the law. Information can be
disclosed to other health care providers only on a
strictly “need to know” basis unless the patient
has given explicit consent.
WMA DECLARATION OF LISBON ON THE
RIGHTS OF THE PATIENT
Right to confidentiality
All identifiable information about a patient’s health status,
medical condition, diagnosis, prognosis and treatment and
all other information of a personal kind must be kept
confidential, even after death.
Exceptionally, descendants may have a right of access to
information that would inform them of their health risks.
WMA DECLARATION OF LISBON ON THE RIGHTS OF THE
PATIENT
Right to confidentiality
All identifiable patient data must be protected. The
protection of the data must be appropriate to the manner
of its storage. Human substances from which identifiable
data can be derived must be likewise protected.
• To provide patients with appropriate care physicians
have to disclose the information to their colleagues (the
members of a health care team). In this case physicians
do not break the law because generally, all team
members have authorized access to confidential
information about the patients they care for and assume
the duty of protecting that information from others who
do not have access to it.
THE RULE OF CONFIDENTIALITY
There are cases when a physician feels naturally inclined to
share information, such as responding to an inquiring
spouse, the requirements for making an exception to
confidentiality may not be met.
THE RULE OF CONFIDENTIALITY
• If there is no explicit permission from a patient to share
information with a family member, it is generally not
ethically justifiable to do so. Only in case a spouse is at
specific risk of harm directly related to a diagnosis, it
remains a patient's rather than a physician's obligation to
inform the spouse.
THE RULE OF CONFIDENTIALITY
• WMA International Code of Medical Ethics (Duties of
Physicians to Patients)
A physician shall respect a patient's right to
confidentiality. It is ethical to
disclose confidential information
when the patient consents to it or
when there is a real and imminent
threat of harm to the patient or to
others and this threat can be only
removed by a breach of
confidentiality.
THE RULE OF CONFIDENTIALITY
If confidentiality must be broken, only those with an
absolute need to know should be given access to that
information, and only the information that is needed to
prevent harm should be revealed. In most cases, a patient
should be notified that confidentiality is to be violated.
SUMMARY
• Confidentiality = private information about patients if
kept top secret.
• Exceptions: private information can be disclosed if:
• 1. The patient gives consent.
• 2. Doctors need to obtain the colleagues’ pieces of advice.
• 3. The court gives the order to reveal the information.
• 4. Descendants have the right to know the diagnosis of
the late relative.
• 5. The patient presents a threat for the closest
surrounding.
THE RULE OF INFORMED CONSENT
• Historically the authority to
make medical decisions used to
lie squarely in the hands of
physicians. However, complex
social changes have resulted in
acceptance of the idea that
patients have a right to know
everything about their health,
available diagnostic and
treatment options, about their
benefits and probable risks, and,
consequently, they have a right to
choose among the alternatives.
THE RULE OF INFORMED CONSENT
• The process by which the treating health care provider
discloses appropriate information to a competent patient
so that the patient may make a voluntary choice to accept
or refuse treatment is called informed consent.
TYPES OF CONSENT
explicit (expressed)
implicit (implied)
Implicit consent is always given orally.
Example:
It is common for a patient to arrange an appointment with
a doctor, to keep the appointment, to volunteer a history, to
answer questions relating to the history and to submit
without objection to physical examination. In these
circumstances consent is clearly implied.
EXPLICIT (EXPRESSED) CONSENT
• Explicit (expressed) consent may be in an oral or
written form. It should be obtained when the treatment
is likely to be more than mildly painful, when it carries
risk, or when it will result in ablation of a bodily
function.
• The main disadvantage of the explicit consent obtained
orally is that patients can change their minds or may not
recall what they authorized; after the procedure or
treatment has been carried out, they may attempt to take
the position it had not been agreed to or was not
acceptable or justified.
EXPLICIT (EXPRESSED) CONSENT
Expressed consent in a written form should be obtained
for:
 surgical operations;
invasive investigative procedures.
It is prudent to obtain written consent also whenever
analgesic, narcotic or anaesthetic agents will significantly
affect the patient’s level of consciousness during the
treatment.
REFUSAL OF TREATMENT
A patient has got a right to refuse treatment even when it is
clear that treatment is necessary to preserve life or health.
However, doctors should bear in mind that the refusal of
treatment can be treated as the one based on inadequate
information about the potential consequences of declining
of what had been recommended.
REFUSAL OF TREATMENT
While recognizing an individual’s right to refuse, doctors
must at the same time explain the consequences of the
refusal without creating a perception of coercion in
seeking consent. Refusal of the recommended treatment
does not necessarily mean the refusal of all treatments.
Reasonable alternatives should be explained and offered to
the patient.
THE COMPONENTS OF THE INFORMED
CONSENT
• The main goal of a health care worker obtaining the
Informed Consent is to be sure that a patient is fully and
adequately informed.
WMA DECLARATION OF LISBON ON THE RIGHTS OF THE
PATIENT
Right to self-determination
The patient has the right to self-determination, to make free
decisions regarding himself/herself. The physician will inform the
patient of the consequences of his/her decisions.
A mentally competent adult patient has the right to give or
withhold consent to any diagnostic procedure or therapy. The
patient has the right to the information necessary to make his/her
decisions. The patient should understand clearly what is the
purpose of any test or treatment, what the results would imply,
and what would be the implications of withholding consent.
The patient has the right to refuse to participate in research or the
teaching of medicine.
EXCEPTIONS TO THE RULE OF THE
INFORMED CONSENT
The rule of the informed consent can be broken in
the following cases:
It a patient is a child. Children are not
autonomous persons able to make correct
decisions. All the manipulations are made with
the parents’/guardians’ informed consent.
If a person is declared incompetent by the court.
If a patient is out of conscience.
EXCEPTIONS TO THE RULE OF THE
INFORMED CONSENT
• The followers of the religious sect “Jehovah's Witnesses ”
reject blood transfusion, seeing it as sinful.
• How many Jehovah’s Witnesses children suffered from
preventable childhood diseases due to the refusal of the
perents to allow vaccinations!!!!
• It is important to remember that when a child’s life is at
stake doctors must remind the parents of their parental
obligations!!!
Adolescents at the age of 16 may independently consent to
his or her medical treatment.
N.B.! Prudent doctors involve a parent or guardian in
pretreatment discussions, especially when the proposed
treatment can carry serious risks.
Emergency medical treatment – no
consent required
A doctor or dentist may perform emergency treatment on a
child under 16 without the consent of that child, parent or
guardian if the practitioner believes that it is urgently
required to save a child's life, to prevent serious damage to
his/her health, or to relieve significant pain or distress.
There is a similar provision allowing emergency treatment
to be given if someone is 16 or over and unable to give
consent.
WMA DECLARATION OF LISBON ON THE RIGHTS OF THE
PATIENT
The unconscious patient
If the patient is unconscious or otherwise unable to express his/her
will, informed consent must be obtained whenever possible, from a
legally entitled representative.
If a legally entitled representative is not available, but a medical
intervention is urgently needed, consent of the patient may be
presumed, unless it is obvious and beyond any doubt on the basis of
the patient’s previous firm expression or conviction that he/she
would refuse consent to the intervention in that situation.
However, physicians should always try to save the life of a patient
unconscious due to a suicide attempt.
WMA DECLARATION OF LISBON ON THE RIGHTS OF THE
PATIENT
• The legally incompetent patient
If a patient is a minor or otherwise legally incompetent, the consent of a
legally entitled representative is required in some jurisdictions.
Nevertheless the patient must be involved in the decision-making to the
fullest extent allowed by his/her capacity.
If the legally incompetent patient can make rational decisions, his/her
decisions must be respected, and he/she has the right to forbid the
disclosure of information to his/her legally entitled representative.
If the patient’s legally entitled representative, or a person authorized by
the patient, forbids treatment which is, in the opinion of the physician,
in the patient’s best interest, the physician should challenge this
decision in the relevant legal or other institution. In case of emergency,
the physician will act in the patient’s best interest.
TRUTH -TELLING
Telling the truth is a complicated business especially for
health care professionals.
Have physicians really got a right to withhold information
from their patients?
Is it ethically right to lie to patients?
TRUTH -TELLING
The Hippocratic Oath is notably silent on the issue of telling
patients the truth.
In fact, Hippocrates advised physicians to “calmly conceal
most things from their patients… turning their attention
away from what is being done to them... revealing nothing
of their future or present conditions.”
TRUTH -TELLING
So from ancient times until comparatively recently, lying to
patients was not “a crime.”
Indeed “to lie like a physician” used to be a compliment!
TRUTH -TELLING
The current thought is completely different.
The General Medical Council (GMC) states that doctors
have a duty to be “honest and trustworthy.”
WMA DECLARATION OF LISBON ON THE RIGHTS OF THE
PATIENT
Right to information
The patient has the right to receive information about
himself/herself recorded in any of his/her medical records,
and to be fully informed about his/her health status
including the medical facts about his/her condition.
However, confidential information in the patient’s records
about a third party should not be given to the patient
without the consent of that third party.
WMA DECLARATION OF LISBON ON THE
RIGHTS OF THE PATIENT
• Exceptionally, information may be withheld from the
patient when there is good reason to believe that this
information would create a serious hazard to his/her life
or health.
WMA DECLARATION OF LISBON ON THE RIGHTS OF THE
PATIENT
Right to information
Information should be given in a way appropriate to the
patient’s culture and in such a way that the patient can
understand.
The patient has the right not to be informed on his/her
explicit request, unless required for the protection of
another person’s life.
The patient has the right to choose who, if anyone,
should be informed on his/her behalf.
TRUTH -TELLING
• Today doctors giving patients truthful information help
them to become informed participants in important
health care decisions.
• Thus, a patient should be told all relevant aspects of
his/her illness, including the nature of the illness itself,
expected outcomes with a reasonable range of treatment
alternatives, risks and benefits of treatment, and other
information deemed relevant to that patient's personal
values and needs.
IS IT ETHICALLY RIGHT TO TELL A PATIENT
BAD NEWS?
If a physician has some reasons to think that disclosure
would create a real and predictable harmful effect on a
patient, it may be justified to withhold truthful information.
WHAT TO DO IF A PATIENT'S FAMILY ASKS A
PHYSICIAN TO WITHHOLD THE TRUTH FROM
THE PATIENT?
• Family members often ask physicians to withhold a
terminal or serious diagnosis or prognosis from
patients.
• Usually they do not want their loved ones to hear
potentially painful information.
• If a physician is sure that truthful disclosure may create
real and predictable harm, in this case withholding may
be appropriate.
THANK YOU FOR YOUR ATTENTION!!!!

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Rules of Bioethics 2019.pptx

  • 1. FEDERAL STATE BUDGETARY EDUCATIONAL ESTABLISHMENT OF HIGHER EDUCATION “KURSK STATE MEDICAL UNIVERSITY” OF THE MINISTRY OF PUBLIC HEALTH OF THE RUSSIAN FEDERATION DEPARTMENT OF PHILOSOPHY Lecture in Bioethics THE MAIN PRINCIPLES AND RULES OF BIOETHICS Lecturer: PhD, Assoc. Prof. of the Dep. of Philosophy Zh. G. Simonova Kursk 2020
  • 2. OUTLINE OF THE LECTURE • 1. The Main Principles of Biomedical Practice. • 1.1. The Principle of Non-maleficence. • 1.2. The Principle of Beneficence. • 1.3. The Principle of Respect for Autonomy. • 1.4. The Principle of Justice. • 2. The Main Rules of Bioethics. • 2.1. The Rule of Confidentiality. • 2.2. Informed Consent. • 2.3. Truth-Telling. •
  • 4. DEFINITION Principle – 1. A basic truth, law, or assumption. 2. The collectivity of moral or ethical standards or judgments.
  • 5. DEFINITION The term “Principlism” belongs to American researchers K.D. Clouser and B. Gert. The term itself helps understand that ethical principles are used as the basis for making moral decisions.
  • 6. HISTORY OF THE PRINCIPLES The Belmont Report, 1979 (the report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research) defines 3 key principles by which it is possible to judge the ethicality of biomedical researches. These principles included: • respect for autonomy of the patient, • beneficence, • justice.
  • 7. HISTORY OF THE PRINCIPLES American scientists Tom Beauchamp and James Childress in their turn proposed the Four-Principles approach having added the principle of non-maleficence to the above- mentioned key ones. 4 Principles • non-maleficence • beneficence • respect for autonomy of the patient • justice
  • 8. 4 PRINCIPLES OF BIOETHICS • Nonmaleficence – Do No Harm • Beneficence – Do Good • Respect for Autonomy of the Patient – free-will • Justice – social distribution of benefits.
  • 9. THE PRINCIPLE OF NONMALEFICENCE Primum non nocere (First, do no harm) What does it mean not to do harm? Hippocrates (460 BC–370 BC)
  • 10. THE PRINCIPLE OF NONMALEFICENCE - Doctors should not intentionally create a harm or injury to their patients, either through acts of commission or omission. - Doctors should avoid negligence (a careless or unreasonable risk of harm upon patients). - If harm is inevitable it should be minimized. - Medical competence is obligatory.
  • 11. THE PRINCIPLE OF BENEFICENCE The word “benefit” can be defined as something that promotes well-being. Health benefit can be interpreted as: • relief of sufferings; • care; • prevention of diseases, illnesses, disabilities; • psychological benefit.
  • 12. THE PRINCIPLE OF BENEFICENCE The principle of beneficence – was formulated in the Middle Ages by Paracelsus. This principle means that the main duty of health care providers is not only to avoid harming patients but also to take positive steps to prevent and to remove such harm from them (e.g. vaccination, isolation of patients suffering from infections disease ) Paracelsus 1493-1541
  • 13. THE PRINCIPLE OF BENEFICENCE Paracelsus 1493-1541 Advice given by Paracelsus:  humane treatment of patients;  understand the underlying or psychological origins of any ailment, illness or disease;  healing power of a doctor-patient talk benefitting a patient
  • 14. THE PRINCIPLE OF RESPECT FOR AUTONOMY OF THE PATIENT • A patient as an autonomous agent with a right to hold views, to make choices, and to take actions based on personal values and beliefs. • Patients have the right to weigh the benefits and risks of alternative treatments, including the alternative of no treatment, and to select the alternative that best promotes their own values. • This principle in connected with the rule of Informed Consent.
  • 15. THE PRINCIPLE OF JUSTICE Justice in health care is usually defined as a form of fairness. This implies the fair distribution of goods in society. Persons who are equals should qualify for equal treatment.
  • 16. THE PRINCIPLE OF JUSTICE Our society uses a variety of factors as criteria for distributive justice, including the following: • To each person an equal share • To each person according to need • To each person according to effort • To each person according to contribution.
  • 17. THE PRINCIPLE OF MEDICAL DEONTOLOGY This principle was introduced into Russian medicine in the 1940s by Professor Nickolay Petrov. He also worked out the principles of surgical deontology. The main idea of this principle is that a health care provider should observe his professional duty taking into account legal and moral norms.
  • 18. THE MAJOR RULES OF BIOMEDICAL PRACTICE
  • 19.
  • 20. THE RULE OF CONFIDENTIALITY Both the process and the result of treatment depend on a patient’s frankness and honesty. Thus, creating a trusting environment by respecting a patient’s privacy encourages him/her to be as honest as possible during the process of communication and collaboration with a physician.
  • 21. THE RULE OF CONFIDENTIALITY Everything that a physician hears from his patients or discusses with them ought to be kept in the strictest secret.
  • 22. THE RULE OF CONFIDENTIALITY The mentioned postulate goes back to the Hippocratic Oath which reads: “And whatsoever I shall see or hear in the course of my profession, as well as outside my profession in my communication with men, if it be what should not be published abroad, I will never divulge, holding such things to be holy secrets.”
  • 23. THE RULE OF CONFIDENTIALITY In this regard confidentiality is one of the core tenets of medical practice. Confidentiality – is one of the rules of Bioethics saying that the information a patient reveals to a health care provider is private and has limits on how and when it can be disclosed to a third party; usually the health care provider must obtain permission from the patient to make such a disclosure.
  • 24. THE RULE OF CONFIDENTIALITY • The obligation of confidentiality prohibits health care providers from disclosing information about their patients’ cases to others without permission and encourages the providers to take precautions to ensure that only authorized access occurs.
  • 25. WMA DECLARATION OF LISBON ON THE RIGHTS OF THE PATIENT • Right to confidentiality • Confidential information can only be disclosed if the patient gives explicit consent or if expressly provided for in the law. Information can be disclosed to other health care providers only on a strictly “need to know” basis unless the patient has given explicit consent.
  • 26. WMA DECLARATION OF LISBON ON THE RIGHTS OF THE PATIENT Right to confidentiality All identifiable information about a patient’s health status, medical condition, diagnosis, prognosis and treatment and all other information of a personal kind must be kept confidential, even after death. Exceptionally, descendants may have a right of access to information that would inform them of their health risks.
  • 27. WMA DECLARATION OF LISBON ON THE RIGHTS OF THE PATIENT Right to confidentiality All identifiable patient data must be protected. The protection of the data must be appropriate to the manner of its storage. Human substances from which identifiable data can be derived must be likewise protected.
  • 28. • To provide patients with appropriate care physicians have to disclose the information to their colleagues (the members of a health care team). In this case physicians do not break the law because generally, all team members have authorized access to confidential information about the patients they care for and assume the duty of protecting that information from others who do not have access to it.
  • 29. THE RULE OF CONFIDENTIALITY There are cases when a physician feels naturally inclined to share information, such as responding to an inquiring spouse, the requirements for making an exception to confidentiality may not be met.
  • 30. THE RULE OF CONFIDENTIALITY • If there is no explicit permission from a patient to share information with a family member, it is generally not ethically justifiable to do so. Only in case a spouse is at specific risk of harm directly related to a diagnosis, it remains a patient's rather than a physician's obligation to inform the spouse.
  • 31. THE RULE OF CONFIDENTIALITY • WMA International Code of Medical Ethics (Duties of Physicians to Patients) A physician shall respect a patient's right to confidentiality. It is ethical to disclose confidential information when the patient consents to it or when there is a real and imminent threat of harm to the patient or to others and this threat can be only removed by a breach of confidentiality.
  • 32. THE RULE OF CONFIDENTIALITY If confidentiality must be broken, only those with an absolute need to know should be given access to that information, and only the information that is needed to prevent harm should be revealed. In most cases, a patient should be notified that confidentiality is to be violated.
  • 33. SUMMARY • Confidentiality = private information about patients if kept top secret. • Exceptions: private information can be disclosed if: • 1. The patient gives consent. • 2. Doctors need to obtain the colleagues’ pieces of advice. • 3. The court gives the order to reveal the information. • 4. Descendants have the right to know the diagnosis of the late relative. • 5. The patient presents a threat for the closest surrounding.
  • 34. THE RULE OF INFORMED CONSENT • Historically the authority to make medical decisions used to lie squarely in the hands of physicians. However, complex social changes have resulted in acceptance of the idea that patients have a right to know everything about their health, available diagnostic and treatment options, about their benefits and probable risks, and, consequently, they have a right to choose among the alternatives.
  • 35. THE RULE OF INFORMED CONSENT • The process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment is called informed consent.
  • 36. TYPES OF CONSENT explicit (expressed) implicit (implied) Implicit consent is always given orally. Example: It is common for a patient to arrange an appointment with a doctor, to keep the appointment, to volunteer a history, to answer questions relating to the history and to submit without objection to physical examination. In these circumstances consent is clearly implied.
  • 37. EXPLICIT (EXPRESSED) CONSENT • Explicit (expressed) consent may be in an oral or written form. It should be obtained when the treatment is likely to be more than mildly painful, when it carries risk, or when it will result in ablation of a bodily function. • The main disadvantage of the explicit consent obtained orally is that patients can change their minds or may not recall what they authorized; after the procedure or treatment has been carried out, they may attempt to take the position it had not been agreed to or was not acceptable or justified.
  • 38. EXPLICIT (EXPRESSED) CONSENT Expressed consent in a written form should be obtained for:  surgical operations; invasive investigative procedures. It is prudent to obtain written consent also whenever analgesic, narcotic or anaesthetic agents will significantly affect the patient’s level of consciousness during the treatment.
  • 39. REFUSAL OF TREATMENT A patient has got a right to refuse treatment even when it is clear that treatment is necessary to preserve life or health. However, doctors should bear in mind that the refusal of treatment can be treated as the one based on inadequate information about the potential consequences of declining of what had been recommended.
  • 40. REFUSAL OF TREATMENT While recognizing an individual’s right to refuse, doctors must at the same time explain the consequences of the refusal without creating a perception of coercion in seeking consent. Refusal of the recommended treatment does not necessarily mean the refusal of all treatments. Reasonable alternatives should be explained and offered to the patient.
  • 41. THE COMPONENTS OF THE INFORMED CONSENT
  • 42. • The main goal of a health care worker obtaining the Informed Consent is to be sure that a patient is fully and adequately informed.
  • 43. WMA DECLARATION OF LISBON ON THE RIGHTS OF THE PATIENT Right to self-determination The patient has the right to self-determination, to make free decisions regarding himself/herself. The physician will inform the patient of the consequences of his/her decisions. A mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy. The patient has the right to the information necessary to make his/her decisions. The patient should understand clearly what is the purpose of any test or treatment, what the results would imply, and what would be the implications of withholding consent. The patient has the right to refuse to participate in research or the teaching of medicine.
  • 44. EXCEPTIONS TO THE RULE OF THE INFORMED CONSENT The rule of the informed consent can be broken in the following cases: It a patient is a child. Children are not autonomous persons able to make correct decisions. All the manipulations are made with the parents’/guardians’ informed consent. If a person is declared incompetent by the court. If a patient is out of conscience.
  • 45. EXCEPTIONS TO THE RULE OF THE INFORMED CONSENT • The followers of the religious sect “Jehovah's Witnesses ” reject blood transfusion, seeing it as sinful. • How many Jehovah’s Witnesses children suffered from preventable childhood diseases due to the refusal of the perents to allow vaccinations!!!! • It is important to remember that when a child’s life is at stake doctors must remind the parents of their parental obligations!!!
  • 46. Adolescents at the age of 16 may independently consent to his or her medical treatment. N.B.! Prudent doctors involve a parent or guardian in pretreatment discussions, especially when the proposed treatment can carry serious risks.
  • 47. Emergency medical treatment – no consent required A doctor or dentist may perform emergency treatment on a child under 16 without the consent of that child, parent or guardian if the practitioner believes that it is urgently required to save a child's life, to prevent serious damage to his/her health, or to relieve significant pain or distress. There is a similar provision allowing emergency treatment to be given if someone is 16 or over and unable to give consent.
  • 48. WMA DECLARATION OF LISBON ON THE RIGHTS OF THE PATIENT The unconscious patient If the patient is unconscious or otherwise unable to express his/her will, informed consent must be obtained whenever possible, from a legally entitled representative. If a legally entitled representative is not available, but a medical intervention is urgently needed, consent of the patient may be presumed, unless it is obvious and beyond any doubt on the basis of the patient’s previous firm expression or conviction that he/she would refuse consent to the intervention in that situation. However, physicians should always try to save the life of a patient unconscious due to a suicide attempt.
  • 49. WMA DECLARATION OF LISBON ON THE RIGHTS OF THE PATIENT • The legally incompetent patient If a patient is a minor or otherwise legally incompetent, the consent of a legally entitled representative is required in some jurisdictions. Nevertheless the patient must be involved in the decision-making to the fullest extent allowed by his/her capacity. If the legally incompetent patient can make rational decisions, his/her decisions must be respected, and he/she has the right to forbid the disclosure of information to his/her legally entitled representative. If the patient’s legally entitled representative, or a person authorized by the patient, forbids treatment which is, in the opinion of the physician, in the patient’s best interest, the physician should challenge this decision in the relevant legal or other institution. In case of emergency, the physician will act in the patient’s best interest.
  • 50. TRUTH -TELLING Telling the truth is a complicated business especially for health care professionals. Have physicians really got a right to withhold information from their patients? Is it ethically right to lie to patients?
  • 51. TRUTH -TELLING The Hippocratic Oath is notably silent on the issue of telling patients the truth. In fact, Hippocrates advised physicians to “calmly conceal most things from their patients… turning their attention away from what is being done to them... revealing nothing of their future or present conditions.”
  • 52. TRUTH -TELLING So from ancient times until comparatively recently, lying to patients was not “a crime.” Indeed “to lie like a physician” used to be a compliment!
  • 53. TRUTH -TELLING The current thought is completely different. The General Medical Council (GMC) states that doctors have a duty to be “honest and trustworthy.”
  • 54. WMA DECLARATION OF LISBON ON THE RIGHTS OF THE PATIENT Right to information The patient has the right to receive information about himself/herself recorded in any of his/her medical records, and to be fully informed about his/her health status including the medical facts about his/her condition. However, confidential information in the patient’s records about a third party should not be given to the patient without the consent of that third party.
  • 55. WMA DECLARATION OF LISBON ON THE RIGHTS OF THE PATIENT • Exceptionally, information may be withheld from the patient when there is good reason to believe that this information would create a serious hazard to his/her life or health.
  • 56. WMA DECLARATION OF LISBON ON THE RIGHTS OF THE PATIENT Right to information Information should be given in a way appropriate to the patient’s culture and in such a way that the patient can understand. The patient has the right not to be informed on his/her explicit request, unless required for the protection of another person’s life. The patient has the right to choose who, if anyone, should be informed on his/her behalf.
  • 57. TRUTH -TELLING • Today doctors giving patients truthful information help them to become informed participants in important health care decisions. • Thus, a patient should be told all relevant aspects of his/her illness, including the nature of the illness itself, expected outcomes with a reasonable range of treatment alternatives, risks and benefits of treatment, and other information deemed relevant to that patient's personal values and needs.
  • 58. IS IT ETHICALLY RIGHT TO TELL A PATIENT BAD NEWS? If a physician has some reasons to think that disclosure would create a real and predictable harmful effect on a patient, it may be justified to withhold truthful information.
  • 59. WHAT TO DO IF A PATIENT'S FAMILY ASKS A PHYSICIAN TO WITHHOLD THE TRUTH FROM THE PATIENT? • Family members often ask physicians to withhold a terminal or serious diagnosis or prognosis from patients. • Usually they do not want their loved ones to hear potentially painful information. • If a physician is sure that truthful disclosure may create real and predictable harm, in this case withholding may be appropriate.
  • 60. THANK YOU FOR YOUR ATTENTION!!!!