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Objectives
At the end of this course you should be able to;
Explain concepts of ethics and professional ethics
Analyze medical ethics and law
Describe the basic principles of ethics
Explain role of ethics in medical research
Avoid malpractice and negligence
Discuss about informed consent
Analyze the importance of anesthetic record
Differentiate hazards of Anesthesia
12/2/2019 ETHICS 2
SOME DEFINITIONS
• Ethics – is simply the philosophical study of such concepts as
Right and Wrong, Good and Bad, Rights and Duties.
• Moral philosophy is equivalent to Ethics, but takes a Latin root of
the word rather than a Greek one.
• Applied Ethics is the application of Ethical theory to practical
problems such as (for instance) Animal Rights, Environmental
Issues, Legal issues.
• Medical Ethics is a large sub-group of Applied Ethics.
12/2/2019 ETHICS 3
Definition…
• Meta-ethics is the consideration of basic questions about the
underpinning of Ethics – questions like “Is there an Absolute Right
or Wrong?”, and “Does Right and Wrong depend purely on
individuals opinions?”
• Medical Law – is the division of Law devoted to issues of Medical
importance – such as Negligence, Consent, Confidentiality, End of
Life Decisions. Medical law is often underpinned by Medical
Ethics, but can often diverge quite markedly from ethical principles
and can be quite pragmatic.
• Common law is the law derived from Judge made decisions.
12/2/2019 ETHICS 4
What is ethics?
• Is the study of moral principles governing or influencing
conduct(right and wrong).
• Is the branch of knowledge concerned with moral principles.
• Is the standard that govern the conduct of a person, especially a
member of a profession.
• is the value dimension of human decision making and
behavior which includes rights, responsibilities and virtues and
also good and bad.
• Morality is study of moral standards and how they affect conduct.
12/2/2019 ETHICS 5
Why study ethics?
• The study of ethics is important to prepare learners to recognize
difficult situations and to deal with them in rational and
principled manner.
To function at the highest professional level
To avoid legal problems
12/2/2019 ETHICS 6
What is Professional Ethics?
• Professional ethics is the personal and corporate standards of
behavior expected of the members of a particular profession.
• Many professions that are trusted by the public to apply expert
knowledge (doctors, engineers, surveyors, accountants and the
like) have a Code of ethics which sets out their expectations of a
member’s behavior and the boundaries within which members
have to operate.
12/2/2019 ETHICS 7
What is professional ethics?...
• A Code of ethics( a document created to set the standards for
ethically acceptable behavior) helps to clarify the profession’s
values provides a reference point for decision making and can be
used as a framework for discipline.
• Most Codes of ethics are principles based, providing guidance as to
the principles on which professional judgments and decisions
should be based, rather than a rigid system of rules.
• Professional ethics concerns one's conduct of behavior and practice
when carrying out professional work.
• System of conduct to guide the practice of a specific discipline.
12/2/2019 ETHICS 8
Medical Ethics
is the application of ethics to the practice of
medicine.
• Is the study of how a health professional might provide medical
care to the best of their ability and for the maximum benefit of their
patients or society.
• Medical ethics is a system of moral principles that apply values and
judgments to the practice of medicine.
12/2/2019 ETHICS 9
Medical ethics and law
• Medical ethics is closely related to law.
• In most countries there are laws that specify how HPs are required
to deal with ethical issues in patient care and research.
• In addition the medical licensing and regulatory officials in each
country can do and punish HPs for ethical violations.
• But ethics and law are not identical.
• Ethics describes higher standards of behavior than does the law
and occasionally ethics requires that physicians disobey laws that
demand unethical behavior.
• Moreover laws differ significantly from one country to another
while ethics is applicable across national boundaries.
12/2/2019 ETHICS 10
Who decides what is ethical?
• The answer to the question, “who decides what is ethical for people
in general?” therefore varies from one society to another and even
within the same society.
• In liberal societies, individuals have greater deal of freedom to
decide for themselves what is ethical although they will likely be
influenced by their families, friends, religion ,media and other
external sources. .
12/2/2019 ETHICS 11
Who decides what is ethical?...
• In more traditional societies, family and clan elders, religious
authorities and political leader have greater role than individuals in
determining what is ethical.
• Despite these differences, it seems that most human beings can
agree on some fundamental ethical principles, namely, the basic
human rights proclaimed in the United Nations Universal
Declaration of Human Rights and other widely accepted and
officially endorsed documents.
12/2/2019 ETHICS 12
Who decides what is ethical?...
The human rights that are especially important for medical ethics
include:
all human beings are born free and equal in dignity and rights
Right to life
Right to freedom from discrimination, torture and cruel inhuman or
degrading treatment
Right to medical care
Right to freedom of opinion and expression to equal access to
public service in one’s country, and to medical care.
12/2/2019 ETHICS 13
Who decides what is ethical for HPs?
• In many not most, countries medical association have been
responsible for developing and enforcing the applicable ethical
standard.
• Depending on the countries approach medical law, these standards
may have legal status.
12/2/2019 ETHICS 14
Who decides what is ethical for HPs?...
• The ethical directives of medical association are greater in nature
they can't deal with every situation that HPs might face in their
medical practice.
• In most situations HPs have to decide to themselves what is right
way to act, but in making decision it is helpful to know what other
HPs would do in similar situation.
• Medical code of ethics and policy statements reflect a general
consensus about the way HPs act and they should be followed
unless there are good reasons for acting other wise.
12/2/2019 ETHICS 15
Does medical ethics change?
• There can be little doubt that some aspects of medical ethics
have changed over the years.
• Until recently physicians had the right and the duty to decide
how patients should be treated and there was no obligation to
obtain the patient’s informed consent.
• In contrast, the 2005 version of the WMA Declaration on the
Rights of the Patient begins with this statement:
• “The relationship between HPs, their patients and broader
society has undergone significant changes in recent times.
12/2/2019 ETHICS 16
Does medical ethics change?...
• While a physician should always act according to his/her
conscience, and always in the best interests of the patient, equal
effort must be made to guarantee patient autonomy and justice.”
• Until recently, physicians generally considered themselves
accountable only to themselves, to their colleagues in the medical
profession and, for religious believers, to God.
• Nowadays, they have additional accountabilities to their patients,
to third parties such as hospitals and managed healthcare
organizations, to medical licensing and regulatory authorities, and
often to courts of law.
12/2/2019 ETHICS 17
Does medical ethics change?...
• Medical ethics has changed in other ways.
• Participation in abortion was forbidden in medical code of ethics
but now it is legalized in many countries including Ethiopia.
12/2/2019 ETHICS 18
Does medical ethics differ from one country to
another?
• Just as medical ethics change over time in response to development
in medical science and technology as well as in societal values so
does differ country to country depending on these some factors;
• On euthanasia, for example, there is a significant difference of
opinion among national medical associations.
• Some condemn it while others like Royal Duch Medical
Association and some USA states support it.
12/2/2019 ETHICS 19
Cont…
• Physicians in some countries are confident that they will not be
forced by their government to do any thing to do unethical while in
other countries it may be difficult for them to meet their ethical
obligation.
• Most other issues are similar so the similarities are more than the
differences.
• The fundamental values of medical ethics such as compassion
,competence and autonomy along with physician experience and
skills in all aspects of medicine and health care provide a sound
basis for analyzing ethical issues in medicine and arriving at
solutions that are in the best interests of individual patients and
citizens and public health in general.
12/2/2019 ETHICS 20
How do individuals decide what is ethical?
• Many ethical issues arise in medical practice for which there is no
guidance from medical associations.
• Individuals are ultimately responsible for making their own ethical
decisions and for implementing them.
• Rational and non-rational
• It is important to note that non-rational doesn’t mean irrational
simply that it is to be distinguished from the systematic reflective
use of reason in decision making.
12/2/2019 ETHICS 21
Non-rational approaches
• Obedience
• Imitation
• Feeling or desire
• Intuition
• habit
12/2/2019 ETHICS 22
1. Obedience
• Common way of making ethical decision.
• By those who work within authoritarian structures (e.g. the
military,police,some religious organizations and many
businesses).
• Morality consists in following the rules and instructions of those
in authority whether or not agree with them.
12/2/2019 ETHICS 23
2 . Imitation
• is similar to obedience in that it subordinates one’s judgment
about right and wrong to that of another person, in this case, a
role model.
• Morality consists in following examples of the role model.
• Most common way of learning medical ethics by aspiring
physicians with the role models being the senior consultants.
12/2/2019 ETHICS 24
3.Feeling or desire
• Subjective approach to moral decision making behavior.
• What Is right is what feels right satisfies one’s desire.
• What is wrong is what feels wrong frustrates one’s desire.
• The measure of morality is to be found within each individuals
and can vary individuals to individuals and even within the
some individual over time.
12/2/2019 ETHICS 25
4.Intuition
• An immediate perception of the right way to act in situations.
• It is similar to desire in that it is entirely subjective, how ever it
differs because its location is in the mind than the will.
• It is neither systematic nor reflexive but directs moral decisions
through a simple flash of insight,
• Like feeling and desire, it can vary greatly from one individual
to an other and the some individual over time
12/2/2019 ETHICS 26
5.Habit
• Is a very efficient method of moral decision making since there is
no need to repeat a systematic decision making process each time
a moral issue arises similar to one that has been dealt with
previously.
• However there are bad habits e.g. lying as well as good ones truth
telling.
• Moreover situations that appear similar may require significantly
different decisions.
12/2/2019 ETHICS 27
Rational approaches
• Deontology
• Consequentialism
• Principlism
• Virtue ethics
12/2/2019 ETHICS 28
12/2/2019 ETHICS 29
1.Deontology
• Involves a search for well founded rules that can serve as the
basis for moral decisions.
• An example of such rule is treat all people as equal, its foundation
may religious or non religious.
• Once the rules are established, they have to be applied in specific
situations and there is often room for disagreement about what the
rules require.
12/2/2019 ETHICS 30
2.Consequentialism
• Bases ethical decision making on analysis of the likely
consequences or out come of different choices and actions.
• The end justifies the means.
• The right action is the one that produces the best outcomes.
• Decision making includes cost effectiveness and quality of life.
12/2/2019 ETHICS 31
3.Principlism
• Ethical principles are the basis of making moral decision .
• It applies in particular cases or situations in order to determine
what is right to do taking in account both rules and
consequences.
• Four principles in particular; respect for
autonomy,beneficence,nonmaleficence and justice have been
identified as the most important for ethical decision making in
medical practice.
12/2/2019 ETHICS 32
4.Virtue ethics
Focuses less on decision making and more on the character of
decision makers as reflected in their behavior.
 A virtue is a type of moral excellence.
Virtue is especially important for physicians to be
compassionate.
Other importance includes honest, prudence and dedication.
Physicians who possess these virtues are more likely to make
good decisions and to implement them in a good way.
12/2/2019 ETHICS 33
Virtue ethics…
Virtues;
Compassion
Honesty
Prudence-knowing how to avoid embarrassment/distress
Dedication
12/2/2019 ETHICS 34
CONT…
• Consequentialism and Deontology contrasted
• The table below gives examples of practical ethical issues and
contrasts Consequentialism and Deontology. Some situations seem
to require a Consequentialist approach, and some seem to require a
Deontological approach.
12/2/2019 ETHICS 35
CONT…
12/2/2019 ETHICS 36
Basic principles of medical ethics
• There are four basic principles of medical ethics.
• Each addresses a value that arises in interactions b/n providers
and patients.
• These are;
Autonomy/respect for persons
Beneficence
Non Maleficence
Justice
12/2/2019 ETHICS 37
1.Respect for persons/autonomy
• People should have control over their lives as much as possible because
they are the only people who completely understand their chosen type of
lifestyle.
• People have the right to control what happens to their bodies.
• This principle simply means that an informed, competent adult patient
can refuse or accept treatments, drugs, and surgeries according to their
wishes.
• Respecting the decision making ability of autonomous persons;
tell the truth
respect patients decisions
protect confidential information
obtain consent for interventions
help others make decisions when asked
12/2/2019 ETHICS 38
Respect for persons/autonomy…
• Autonomous persons
• Autonomous choices
Autonomy includes;
 Freedom of will
 Freedom of action
 Free to choose and act
• Privacy and confidentiality
• Promotes informed consent
12/2/2019 ETHICS 39
Autonomy in Research
• Voluntary participation
• Adequate information to make informed consent
• Comprehension
• Full disclosure of risks and benefits
• No undue inducement
• Voluntary termination
• Continuing disclosure
• Legally authorized representative
• Culturally appropriate consent
12/2/2019 ETHICS 40
2.Beneficence
• Acts of kindness or charity that go beyond strict obligation.
• Guides health professionals to do good for patients to act
always in the patients best interests.
• All healthcare providers must strive to improve their patient’s
health, to do the most good for the patient in every situation.
• Common definition – acts of kindness or charity that go beyond
strict obligation
• To do good
• Prevent evil or harm
• Ought to remove evil or harm
• Endeavor to benefit where possible
12/2/2019 ETHICS 41
Beneficence…
• In health care; an obligation to improve health
• In research; Maximize benefits and minimize risks of possible
harms
• Balance risks and benefits
• Promotes risk benefit analysis, post trial benefits etc…
• Provide benefits and balance benefits against risks and harm
• Protect and defend the rights of others
• Prevent harm to others
• Remove conditions that will cause others harm
• Help disabled persons
• Rescue persons in danger
12/2/2019 ETHICS 42
3.Nonmaleficence
• The concept of non-maleficence is embodied by the phrase, "first, do no
harm,". Many consider that should be the main or primary consideration
that is more important not to harm your patient, than to do them good.
• In every situation, healthcare providers should avoid causing harm to their
patients.
• Nonmaleficene is a similar concept to the principle of beneficence but
deals with situations in which none of the outcomes of a treatment are
likely to benefit the patient.
• In this case, the HP should strive to do the list harm to the fewest people.
• The decision making is left to the HP, rather than the patient or others.
12/2/2019 ETHICS 43
Non-maleficence…
• Avoidance of the causation of harm
• Do not kill
• Do not cause pain or suffering to others
• Do not incapacitate others
• Do not cause offense to others
• Do not deprive others of the goods of life
12/2/2019 ETHICS 44
4.Justice
• The principle of justice demands that HPs treat patients fairly.
• Similar patients with similar illnesses should receive similar
treatments.
• Equal treatment – Different treatment requires justification
(experience, age, deprivation, competence, merit, position, etc.)
• What is deserved – People should be treated fairly, and should be
given what they deserve in the sense of what they have earned.
• Promotes issues on subject selections, what is owed them, how
they are treated during and after research.
• Fair distribution
12/2/2019 ETHICS 45
Justice..
• Distribute benefits, risks, and costs fairly
• To each an equal share
• To each according to effort
• To each according to need
• To each according to contribution
• To each according to merit
12/2/2019 ETHICS 46
SUMMERYIN TABLE
12/2/2019 ETHICS 47
Research and Ethics
• Introduction
• Medicine is not an exact science. It does have many general
principles that are valid most of the time, but every patient is
different and what is an effective treatment for 90% of the
population may not work for the other 10%.
• Thus, medicine is inherently experimental.
• Even the most widely accepted treatments need to be monitored
and evaluated to determine whether they are effective for specific
patients and, for that matter, for patients in general.
12/2/2019 ETHICS 48
Introduction….
• All interventional medical treatments has resulted from research.
• The development of new treatments, especially drugs, medical
devices and surgical techniques are also the results of medical
researches.
12/2/2019 ETHICS 49
Historical ease of unethical research
• In the first century BC Cleopatra was reputed to have had a number
of her handmaidens impregnated and subsequently operated upon
at certain times of gestation.
• In 1932,the Japanese subjected tens of thousands of captured
Chinese subjects to a number of horrifying experiments ,some of
which involved live vivisection.
12/2/2019 ETHICS 50
Unethical…
• The Tuskegee syphilis study(1932); Was a 40 year project
administered by the US public health service .
• The government promised 400 men free treatment for bad blood
which had become an epidemic in the country.
• The study sample was made up of poor African and American men
who were told that they had “bad blood".
• They did not receive standard treatment for syphilis even when
penicillin was available later during the study.
12/2/2019 ETHICS 51
Unethical…
• The willow Brook study; This study involved a group of children
diagnosed with mental retardation ,who lived at the willow Brook
state hospital in New York .
• These innocent children were deliberately infected with hepatitis
virus ;early subjects were fed extracts of stools from infected
individuals and later subjects received injections of more purified
virus preparations.
12/2/2019 ETHICS 52
Unethical…
• The tragic history of research abuse by Nazi doctors during
World War II on Jews, gypsies and political prisoners.
• Nazi doctors’ trials for medical experiments conducted among
civilians and allied forces under the custody of the German
Reich without subjects consent committed murders, brutalities,
cruelties, tortures, atrocities and other inhuman acts.
12/2/2019 ETHICS 53
Unethical…
• Nazi medical experiments
• High altitude experiments – conducted in low pressure chambers
that approximate pressure at extremely high altitudes.
• Freezing experiments – subjects remained in ice tanks for 3 hours,
severely chilled and rewarmed.
• Malaria experiments – infected healthy humans with infected
mosquitoes.
12/2/2019 ETHICS 54
• “Permissible medical experiment”
• Nuremberg Code
12/2/2019 ETHICS 55
Nuremberg code
• The Nuremberg code was the first set of basic principles that must
be observed in order to satisfy moral, ethical and legal concepts in
conduct of human participants in research.
• The main points included the statement that:
• That animal experimentation should precede human
experimentation.
• “Voluntary consent of the human subject is absolutely essential.“
• All unnecessary physical and mental suffering and injury should be
avoided;
12/2/2019 ETHICS 56
Nuremberg code…
• The degree of risk to participants should never exceed the
humanitarian importance of the problem and should be minimized
through proper preparations and
• That participants should always be at liberty to withdraw from
experiments.
• The Code has been the model for many professional and
governmental codes since the 1950s and has, in effect, served as
the first international standard for the conduct of research.
• The Nuremberg code was supplemented by the declaration of
Helsinki in 1964.
12/2/2019 ETHICS 57
Declaration of Helsinki
• Originally adopted 1964. was developed by the World Medical
Association for use by the medical community following
dissemination of the Nuremberg Code.
• 1st significant attempt by the medical community to regulate itself.
• Like the Nuremberg Code, the Declaration made Informed consent
a central requirement for ethical research while allowing for
surrogate consent when the research participant is incompetent,
physically or mentally incapable of giving consent, or a minor
• Who are incompetent groups?
12/2/2019 ETHICS 58
Declaration of Helsinki…
• The Declaration also states that research with these groups should
be conducted only when the research is necessary to promote the
health of the population represented and when this research cannot
be performed on legally competent persons.
• It further states that when the subject is legally incompetent but
able to give assent to decisions about participation in research,
assent must be obtained in addition to the consent of the legally
authorized representative.
12/2/2019 ETHICS 59
Declaration of Helsinki…
• The well being and interests of research participants must always
prevail over interests of science and society. (code 5)
• It is the duty of the medical professional to protect the life, privacy
and dignity of the human subject. (Code 10)
• Research must be reviewed by an independent committee (IRB)
before it is conducted. (code 13).
• The subjects must be volunteers and informed participants in the
research project. (code 20).
• Placebo acceptable only “where no proven prophylactic, diagnostic
or therapeutic method exists”.(code 29).
12/2/2019 ETHICS 60
CIOMS Guidelines
• The Council for International Organizations of Medical Sciences
(CIOMS) is an international, NGO, not for profit organization
established jointly by WHO and UNESCO in 1949.
• CIOMS serves the scientific interests of the international
biomedical community in general and has been active in
promulgating guidelines for the ethical conduct of research, among
other activities.
• CIOMS promulgated guidelines in 1993 entitled International
Ethical Guidelines for Biomedical Research Involving Human
Subjects.
12/2/2019 ETHICS 61
CIOMS Guidelines …
• The 15 guidelines address issues including informed consent,
standards for external review, recruitment of participants, and
more.
• The Guidelines are general instructions and principles of ethical
biomedical research.
12/2/2019 ETHICS 62
Research in medical practice
• All HPs make use of the results of medical research in their clinical
practice.
• To maintain their competence, HPs must keep up with the current
research in their area of practice through continuing medical
education/continuing professional development programs, medical
journals and interaction with knowledgeable colleagues.
• Even if they do not engage in research themselves, HPs must know
how to interpret the results of research and apply them to their
patients.
• The most common method of research for practicing HPs is the
clinical trial.
12/2/2019 ETHICS 63
Research in medical practice…
• Before a new drug can be approved by government mandated
regulatory authorities, it must undergo extensive testing for safety
and efficacy.
• The process begins with laboratory studies followed by testing on
animals.
• If this proves promising the four phases of clinical research, are
next:
12/2/2019 ETHICS 64
Research in medical practice…
• usually conducted on a relatively small number of healthy
volunteers, who are often paid for their participation, is intended to
determine what dosage of the drug is required to produce a
response in the human body, how the body processes the drug, and
whether the drug produces toxic or harmful effects.
•
• is conducted on a group of patients who have the disease that the
drug is intended to treat.
• Its goals are to determine whether the drug has any beneficial
effect on the disease and has any harmful side effects.
12/2/2019 ETHICS 65
Research in medical practice…
• ,
• is the clinical trial, in which the drug is administered to a large
number of patients and compared to another drug.
• , takes place after the drug is licensed and
marketed.
• For the first few years, a new drug is monitored for side effects
that did not show up in the earlier phases.
• the pharmaceutical company is usually interested in how well the
drug is being received by HPs who prescribe it and patients who
take it.
12/2/2019 ETHICS 66
Ethically acceptable research
• An ethically accepted research is conducted under the major ethical
principles.
• 1.respect for autonomy
• The involvement competent patients in research should be entirely of
their own violation.
• Participants are of free to withdraw their consent at any time and any
reason.
The three recognized components of consent are of fundamental
importance;
Voluntariness;
the study subjects participation must be entirely based on their wish.
Information;
subjects should be informed;
12/2/2019 ETHICS 67
Ethically accepted research…
What is involved in taking part
Why the research is being done
What the risks might be the subject
What the consequences of these risks might be
Competence
Is the subject competent enough to give consent
12/2/2019 ETHICS 68
International guidelines
• “Every precaution should be taken to respect the privacy of the
subject, the confidentiality of the patient’s information, and to
minimize the impact of the study on the subject’s mental integrity…
and personality…” (Helsinki, 2000)
• The investigator must establish secure safeguards of the
confidentiality of subjects research data.
• Subjects should be told the limits, legal or other, to the investigator’s
ability to safeguard confidentiality and the possible consequences of
breaches of confidentiality” (CIOMS, 2002)
12/2/2019 ETHICS 69
Medical malpractice
• Medical malpractice is improper, illegal or negligent professional
procedure or treatment in the health care service.
• Negligence is the most common medical malpractice.
• Medical negligence is a failure to give proper care over patients.
12/2/2019 ETHICS 70
Negligence
• “Negligence is one type of tort (a wrongfull act) and malpractice
is one type of negligence”
• There are four elements to negligence.
• They include:
• duty,
• breach,
• injury, and
• damages.
12/2/2019 ETHICS 71
Negligence…
• When the patient is seen preoperatively, and the anesthetist agrees
to provide anesthesia care for the patient, a duty to the patient has
been established.
• the duty the anesthetist owes to the patient is to adhere to the
standard of care for the treatment of the patient.
• So once a HPs/patient relationship has been established, the HPs
now owes the patient a certain duty of care.
12/2/2019 ETHICS 72
Negligence…
•
• After this duty of care has been established, the HPs is required to
exercise reasonable care and treat the patient as would other HPs in
his field, following procedures and actions accepted by his peers.
• In a malpractice action, expert witnesses will review the medical
records of the case and determine whether the anesthetist acted in a
reasonable and prudent manner in the specific situation and fulfilled
his or her duty to the patient.
• If they find that the anesthetist either did something that should not
have been done or failed to do something that should have been done,
then the duty to adhere to the standard of care has been breached.
• Therefore, the second requirement for a successful suit will have been
met.
12/2/2019 ETHICS 73
Negligence…
• the breach of duty may lead to the proximate cause of the injury.
• If the odds are better than even that the breach of duty led, however
circuitously, to the injury, this requirement is met.
•
• The victim must suffer damages, economic or non-economic, as a
result of the injury.
• three different types of damages.
12/2/2019 ETHICS 74
Negligence…
• General damages are those such as pain and suffering that directly
result from the injury.
• Special damages are those actual damages that are a consequence
of the injury, such as medical expenses, lost income, and funeral
expenses.
• Punitive damages are intended to punish the physician for
negligence that was reckless, wanton, fraudulent, or willful.
• Punitive damages are exceedingly rare in medical malpractice
cases. More likely in the case of gross negligence is a loss of the
license to practice anesthesia.
12/2/2019 ETHICS 75
 Informed consent is 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.
Consent is based on the ethical principle of respect for persons.
Acknowledge the person’s autonomy
Protect those with diminished autonomy
• Is permission to do something.
• In medicine, consent allows an autonomous patient to define and
protect his or her own interests and to control bodily privacy.
• Autonomous individuals are considered as the best judges of their
own best interests.
12/2/2019 ETHICS 76
Consent…
• The most important goal of informed consent is that the patient has
an opportunity to be an informed participant in the health care
decisions.
• Decisions are made on the basis of a current understanding of the
facts presented when evaluated in a logical manner ,with some
insight shown in to the likely consequences of the decision.
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3 Components

Specific items for disclosure

 Adapt the presentation to the subject’s needs

No threat of harm (coercion) AND no improper reward (undue
influence)
12/2/2019 ETHICS 78
Informed consent
Protection from harm
would protect patient from an “unwise choice”
Protection of autonomy
demands:
full disclosure
comprehension
voluntary
competence to consent
12/2/2019 ETHICS 79
Competence
In the context of this decision
Standards of competence
decision based on rational reasons
decision leads to reasonable result
capacity to make a decision
• Competence judgments are “value laden” / weighed down
12/2/2019 ETHICS 80
Comprehension of information
• Comprehension-understanding the meaning of the information
• Acceptance-believing that the information is true for them.
• Appreciation-apply the information in a way that fosters
understanding of how they will feel.
12/2/2019 ETHICS 81
Voluntariness
• Disclosure of alternate choices.
• Influential vs.controlling inducements (influenced by
circumstances)
Coercion : - threat
Indoctrination :- repeated instruction
manipulation
seduction
rational persuasion : - reasoning
12/2/2019 ETHICS 82
Incompetents
• Patients competency can be affected either by age or medical
condition.
Children
16 and 17 year old children presumed to be competent to give
consent for any treatment that would otherwise constitute a
battery on them.
Children under age of 16 are presumed to be incompetent to
consent and to treatment.
12/2/2019 ETHICS 83
Incompetents…
•
• Mental illness may impair a patients capacity to provide valid
consent or refusal for an anesthetic intervention.
•
• Those with the greatest depth of faith refuse blood(blood product)
transfusion, even if this lead to personal harm or death, believing
that to receive transfusion will result in their eternal damnation.
12/2/2019 ETHICS 84
Incompetents…
• If the patient is determined to be incapacitated/incompetent to
make health care decisions, a surrogate decision maker must speak
for her.
• There is a specific hierarchy of appropriate decision makers
defined by state law.
• If no appropriate surrogate decision maker is available, the
physicians are expected to act in the best interest of the patient
until a surrogate is found or appointed.
12/2/2019 ETHICS 85
Incompetents…
• In rare circumstances, when no surrogate can be identified, a
guardian may have to be appointed by the court.
• The patient's consent should only be presumed rather than obtained,
in emergency situations when the patient is unconscious or
incompetent and no surrogate decision maker is available, and the
emergency interventions will prevent death or disability.
12/2/2019 ETHICS 86
Waiving Consent
Minimal risk studies without procedures that require consent.
Waiving consent must not adversely affect subjects rights and
welfare
Telephone surveys
Interviews
Medical record review
12/2/2019 ETHICS 87
Waiving Documentation of Consent
• Minimal risk studies without procedures that require consent
• When the only link to the subject is the consent document and
that link may pose risk of breach of confidentiality.
• E.g. Medical record review
12/2/2019 ETHICS 88
Protection of Vulnerable Subjects
• Vulnerable and Less Advantaged Persons;
• Persons who are absolutely or relatively incapable of protecting
their interests.
• Insufficient power, intelligence, resources, strength or other needed
attributes to protect their own interests through informed consent.
• Each person when measured against the highest standards of
capability is relatively vulnerable
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Involvement of Vulnerable Subjects
• “The proposed involvement of hospitalized patients, other
institutionalized persons, or disproportionate numbers of
racial or ethnic minorities or persons of low socioeconomic
status should be justified.”
• US National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research: Institutional Review
Boards: Report and Recommendation, 1978
12/2/2019 ETHICS 90
Special Populations
• Fetuses, pregnant women and human in vitro fertilization
• Prisoners
• Children
12/2/2019 ETHICS 91
Why the anesthetists are liable for law suit ?
• Liable= legally responsible
• Suit=a process by which a court of law makes a decision to
settle a disagreement.
ANSWER
Unrealistic expectation
Poor rapport and poor
communication
Greed and or litigious
society
Poor quality of care
12/2/2019 ETHICS 92
why do we study ethics and law
To function at the highest professional level
To avoid legal problems
 Patient injury
 Communication gap
 minimum standard not fulfilled
 Absence of License
 Manipulating and mocked records
 Not taking informed consent
 Delayed referral
 Absence from working area
 Confidentiality
 Not admitting mistakes (Apology
12/2/2019 ETHICS 93
Anesthetic record
• It is of little benefit in legal terms to have delivered good
anesthesia care if it is impossible to identify each component of an
anesthetic agent and when it was performed.
• The record may have to be defended years after the case was
completed, and case has been forgotten.
• A general rule “if it was not written it was not done”
When an incident occurs
Facts should be documented
Avoid using terms such as inadvertently that convey message of
guilt or negligence
Simply record the relavant facts about the incident like
auscultatory findings, spinal level of somatic block
12/2/2019 ETHICS 94
When an incident occurs
• Facts should be documented
• Avoid using terms such as inadvertently that convey message of
guilt or negligence
• Simply record the relavant facts about the incident like
auscultatory findings, spinal level of somatic block
• A frequent complaint is that there is no time to write notes while
responding to a emergency situation
• The solution is to write a perioperative note as soon as possible
making reference to the approximate times of the events
• such records are invaluable in distinguishing b/n a known
complication and actual negligence
12/2/2019 ETHICS 95
Respond appropriately an incident occurs
• The anesthetist should continue to maintain professional contact
with the patient during hospitalization after any incident that might
be related to anesthesia.
• Failure to do so might be interpret as a rejecting the patient.
12/2/2019 ETHICS 96
Recognize malpractice prodromes
• Receiving letters from a previous patient
• Getting request for medical record from attorneys.
• Response should not be hostile & goals are to explain why there is
no liability for the claim to reduce the chance of a lawsuit being
filed.
• Direct correspondence with the patient should be kept to a
minimum.
• Best to work through the insurer or attorney.
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Avoid vicarious liability
• If anesthetist supervising anyone who is incompetent, supervision
must be very close such as double checking preoperative findings,
being present in the operating room during the entire case.
• Do not agree to supervise more simultaneous cases than you can
safely handle.
• Issues of inadequate supervision and pt abandonment are hard to
defend.
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Notification of a lawsuit
• An anesthetist may receive a notice of intent to sue within a
specified period of time or may receive a summons.
• There is finite period of time for a response to the summons and an
assistance of an attorneys will be required.
• Failure to respond within time will result in a directed decision for
the plaintiff.
• Anesthetist should avoid from discussing the case with anyone
other than the attorney, as certain statements may be discoverable
and used by the plaintiff during the trial.
12/2/2019 ETHICS 99
CONT…
• Access to the patient’s medical records is
• permissible, but the temptation to add
• notes must be avoided.
• plaintiff’s attorney has already obtained
• a copy of the medical record, and any
• alteration after the notification of a
• lawsuit will be introduced as evidence of
• negligence.
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Discovery
• After the complaint is answered, both sides begin the process knows
as ‘discovery’.
• The purpose of discovery is to ascertain the “facts” of the case in
preparation for trial.
• It is the responsibility of the jury to decide which facts to believe.
• So juries are, for this reason ,called “triers of fact”
• A strength is a fact that is favorable and a weakness is a fact that is
unfavorable.
• The Medical record is the primary (FIRST) source of the facts.
• A trier of the fact will believe what is written before believing what
is said.
• The notes were completed before any adverse outcome was known,
so records are trusted.
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CONT…
• Second source of facts is the testimony of those who witnessed the
event
• Anesthetist may testify that something that was not recorded was
done or seen.
• It is not as believable as medical records because it relies upon
specific recall of events that may have happened in the remote past.
• Third source of facts is the usual practice pattern of the anesthetist.
• If anesthetist has done something it must be because that is part of
a routine.
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CONT…
• Fourth source of the fact
• It is the expert witness testimony.
• Expert are necessary because the subject of medicine is held to
be beyond the knowledge or understanding of lay jurors.
• Expert will review entire medical record
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Order of credibility
• 1) The anesthesia record and notes
• 2) The expert’s interpretation
• 3) Specific recall
• 4) Usual and customary practice
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Deposition testimony
• The defendant anesthetist testimony is conducted by the plaintiff’s
attorney.
• The plaintiff attorney will attempt to uncover facts favorable to the
plaintiff to ascertain the defense position on the issues in question.
• Prior to the deposition, the defense attorney should meet the
anesthetist to explain the conduct of the procedure, what to bring.
12/2/2019 ETHICS 105
CONT…
• There will be a series of questions .
• There is need to speak slowly and clearly, understanding the
questions, and waiting until the question is fully asked before
answering .
• Answer should be brief and to the point.
• It helps to have a familiar with the dates of training, licence, and
certifications.
12/2/2019 ETHICS 106
Expert witness
• Courts demand that witnesses be called so that the jury can benefit
from the expertise and opinions of uninvolved parties.
• Witnesses who are allowed to give opinions are called expert
witness.
12/2/2019 ETHICS 107
Malpractice suit
To be successful in malpractice suit four elements must be proved
by plain tiff attorney
Duty –the anesthetist owed him or her a duty
Breach of duty-anesthetist failed to fulfill his or her duty
Causation-close causal relation ship exists between the acts of the
anesthetist and the resultant injury
Damages –the actual damages resulted because of the acts of the
anesthetist.
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Why anesthetists are sued ?
Unrealistic expectations
Poor rapport and poor communication
Greed and or litigious society
Poor quality of care
What to do when sued ?
Specific actions
Don't discuss the case with any one
Never alter any records
Gather together all pertinent records
Make notes recalling all events
Cooperate fully with the attorney provided by the insurer or other
bodies.
12/2/2019 ETHICS 109
The Do’s
• Review record
• Analyze the case
• Look for other relevant documents
• Review literature
• Identify experts in the field
• Make a list of fact witness
• Educate your attorney
• The Don’ts
• Don’t discuss the case with any one
• Don’t change the records
• Don’t accept any calls from other attorneys or patient or
family members
• Don’t talk to media
12/2/2019 ETHICS 110
• Euthanasia - is the intentional bringing about of the death of a
patient (by killing or allowing to die) where this is done for the
patient's own sake.
• Note the three parts to the definition
• Intentional
• Killing or allowing to die
• Done for the patient's sake
• Active Euthanasia - is taking of some action in order to cause
death, for the patient's own sake
• Passive Euthanasia - is omitting to take some action which
would prevent or avert death, for the patient's own sake
12/2/2019 ETHICS 111
CONT…
• A patient who refuses treatment (even if that refusal may
shorten the life of the patient) This sounds like Passive
Euthanasia, as defined above.
• However, it is d/t even though the difference is subtle. In Passive
Euthanasia the patient says, "Please don't give me Treatment X,
because I want to die".
• In Refusal of Treatment, the patient says "Please don't give me
Treatment X, it's my right to refuse treatment, and I'll take my
chances" (which may or may not include death) The Doctor's reply
is d/t too - in Passive Euthanasia he may say "It's my duty to
prevent death, I can't go along with this plan - you must have the
treatment" (or he may say "Okay, I agree you’ve had enough
suffering" In Refusal of Treatment, he says, "Well, it's your right
to refuse treatment if you wish, but I need to advise you that I
strongly recommend the treatment I suggested"
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Do not resuscitate’orders
• Again, no statutory law exists. The guidelines that inform clinical
practice in the UK are those provided by the BMA, Royal College
of Nursing and the UK Resuscitation Council joint statement of
2002.
• This may be summarized as follows:
• Principles
• support for patients and people close to them, and effective,
sensitive communication are essential; decisions must be based on
the individual patient’s circumstances and reviewed regularly;
information about CPR and the chances of a successful outcome
needs to be realistic.
12/2/2019 ETHICS 114
CONT…
• In emergencies
• If no advance decision has been made or is known, CPR should be
attempted unless:
• the patient has refused CPR;
• the patient is clearly in the terminal phase of illness;
• the burdens of the treatment outweigh the benefits.
• Advance decision-making
• competent patients should be involved in discussions about
attempting CPR unless they indicate that they do not want to be;
where patients lack competence to participate, people close to them
can be helpful in reflecting their views.
12/2/2019 ETHICS 115
CONT…
• Legal issues
• patient’s rights under the HRA must be taken into account in
decision-making; neither patients nor relatives can demand
treatment which the health care team judges to be inappropriate, but
all efforts will be made to accommodate wishes and preferences; in
England, Wales and Northern Ireland, relatives and people close to
the patient are not entitled in law to take health care decisions for
the patient; in Scotland, adults may appoint a health care proxy to
give consent to medical treatment; health professionals need to be
aware of the law in relation to decision-making for children and
young people.
12/2/2019 ETHICS 116
CONT…
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12/2/2019 ETHICS 118
Causes of action most relevant to anesthetist
• Medical negligence:- Breech of a duty of a standard of care causing
harm
• Wrongful death:- One that occurs earlier that it would have
otherwise.
• If negligence causes death, survivors may sue for damages
• Lack of informed consent Obligation to provide information
material to a reasonable person
• Abandonment-- Obligation to provide continuity of care once a
physician assumes responsibility for the patient
12/2/2019 ETHICS 119
• Vicarious liability – Obligation for reasonable oversight of those
working for the physician
• Loss of chance of recovery or survival- The patient must show that
recovery was likely except for the action of the physician
• Battery- Touching a person without express or implied consent.
There is no need for the plaintiff to prove harm in battery cases
• Assault -The attempt to touch another person.
• There is no need to prove actual harm
12/2/2019 ETHICS 120
• Jehovah’s Witnesses are an international religious organization and
comprise approximately 0.6–0.8% of the adult population in the
US with the greatest percentage residing in the South (36%) or
West (29%).
• Interestingly, the majority of Jehovah’s Witnesses (63%) have no
children.
• However, Jehovah’s Witnesses have the lowest retention rate of
any religious group with only 37% of individuals raised in the faith
as children keeping this religious affiliation into adulthood
12/2/2019 ETHICS 121
CONT…
• Though JWs started in 1870, it was not until 1945 that a ban on blood
transfusions was placed for JW’s.
• This ban on blood transfusions was based on quotes from the Bible,
especially the following: ( New World Translation of the Holy Scriptures –
2013 Revision ).
• Genesis 9:3 - …. Only flesh with its life – with its blood – you must not eat
• Leviticus 17:10–12 - ‘If any man of the house of Israel or any foreigner who is residing
• in your midst eats any sort of blood, I will certainly set my face against the one who is eating
• the blood, and I will cut him off from among his people (Leviticus 17:10). For the life
• of the fl esh is in the blood, and I myself have given it on the altar for you to make atonement
• for yourselves, because it is the blood that makes atonement by means of the life in it
• (Leviticus 17:11). That is why I have said to the Israelites: “None of you should eat blood,
• and no foreigner who is residing in your midst should eat blood” (Leviticus 17:12).
• Acts 15:28–29 - …to keep abstaining from things sacrificed to idols and from blood…
12/2/2019 ETHICS 122
• A 1951 Watchtower article explained the reasoning that led to
this ban on blood
• transfusion: “when sugar solutions are given intravenously, it is
called intravenous feeding. …The transfusion is feeding the
patient blood and …(the patient) is eating it (blood) through his
veins”.
12/2/2019 ETHICS 123
• It is a common misconception that if you give a JW blood
against his or her will, then the JW is still subject to eternal
damnation.
• Another misconception is that if a JW accepts blood then he or
she, too, would be subject to eternal damnation with no chance
of repentance.
• Neither of these is true. According to an e-mail communication
with the JW lead office:
12/2/2019 ETHICS 124
• In fact, since 2000 JWs are not “disfellowshipped” for accepting
blood.
• JWs are considered to have voluntarily “disassociated” from the
Church.
• This means that if a JW does repent he or she can remain in the
fold.
• In order to keep up with advances in medicine (for example,
renal dialysis; cardiopulmonary bypass; blood harvesting
including cell saver (cell salvage), acute normovolemic
hemodilution and autologous blood donation; and organ
transplant), new guidelines for JWs have been developed to aid
members in addressing these clinical situations.
12/2/2019 ETHICS 125
• “A forced blood transfusion would not be viewed as a sin.
• Also, if under extreme pressure & while experiencing undue stress
a JW was to compromise their belief and accept blood transfusions,
in other words, if they caved in at a moment of spiritual weakness
yet still held to their beliefs, that individual would not be ostracized
by the JW community, rather, kindness would be shown and
pastoral help offered. Nevertheless, a forced transfusion or a
compromise with one's conscience may leave the patient with deep
emotional scars.”
12/2/2019 ETHICS 126
• The ethical and legal right of capacitated adults to make medical
decisions for themselves is well-established.
• Autonomous decision making provides adults with the leeway to
make authentic choices consistent with their beliefs and values.
• If an adult patient makes a “bad decision,” the clinician may
confirm capacity and attempt to use gentle persuasion to redirect
the patient, but little precedent exists to override their refusal.
• It may even be considered battery if consent is not obtained from
a capacitated adult patient and his or her known preferences are
overridden.
12/2/2019 ETHICS 127
• When adult patients are unable to make medical decisions on their
own behalf, clinicians try to identify a person to act as the
patient’s “surrogate” and make decisions as his or her proxy.
• In other words, clinicians ask the surrogate to make decisions
based on the patient’s previously expressed wishes (if known), or
to make decisions consistent with the patient’s known values and
interests.
• In pediatrics, children have developing and evolving decisional
capacity as well as beliefs and values.
• Parental authority and familial autonomy over their developing,
vulnerable child creates a unique dynamic that is different from
the moral space in which surrogates make medical decisions.
12/2/2019 ETHICS 128
• Infants and children lack the ability to make autonomous medical decisions and
• therefore parents (or legal guardians) are presumed to have a liberty interest in the “care,
custody, and management” of their children.
• Furthermore, as children age and mature they are able to play an increasing role in the
medical decision making process creating a triangle of decision making between patient,
parent, and provider, which may raise additional complexities.
• While parents are allowed broad discretion in medical decision making, this right is not
absolute.
• As was noted in the case of Prince v Massachusetts , “…Parents may be free to become
martyrs themselves.
• But it does not follow they are free, in identical circumstances, to make martyrs of their
children before they have reached the age of full and legal discretion
12/2/2019 ETHICS 129
• The “best interest of the child” standard is based on the ethical
principles of beneficence, or the “moral obligation to contribute
to the good of others”.
• In the context of medical decision making, it aspires to identify
the medical care (decision) that is in the best interest of the child.
• When parental decision making aligns with a proposed medical
therapy, the care is often delivered without deliberate
consideration of this ethical standard.
12/2/2019 ETHICS 130
• When differences of opinion exist, the standard may be invoked to
substitute the views of a third party (the physician, the courts) over the
views of the parents.
• One expects that most parents do not seek to make decisions they
perceive as harmful, so why do clinicians and families sometimes
collide over what interventions are best for the pediatric patient?
• The best interest standard and the evaluation of the benefits and harms
of alternative medical pathways are inherently subjective, value-laden
judgments.
• Consider a patient with osteosarcoma – based on tumor location and
the response to chemotherapy, the oncologist and surgeon may
recommend amputation rather than a limb sparing technique, but after
evaluation of the information and consideration of their personal
preferences and beliefs, the family may still elect to pursue limb-
sparing.
12/2/2019 ETHICS 131
• The teenager may feel that it is in his long-term best interest to
not have a prosthesis and is willing to accept any increased risks
associated with declining amputation (amputation being what the
physicians consider to be his present day best interest).
• Finally, children are highly dependent on their parents who bear
the burden of their care.
• Parents are likely to consider familial needs – this is the balancing
and rank ordering of the interests of the parents, siblings, and
their child who is the patient in order to reach a determination of
what is the best medical decision
12/2/2019 ETHICS 132
Assent and Children’s Role in Medical Decision
Making
• As children mature, they develop an increasing ability to evaluate
proposed medical interventions and consider the risks and benefits of
the alternatives.
• Children are not treated as rational, autonomous adults but allowed
to participate in decisions in a manner consistent with their
developing capacity.
• Meaningful pediatric assent, which is less stringent than consent,
allows children the opportunity to state their preferences within the
context of their developmental abilities and desire to participate.
• It may be helpful to consider the practical
• The “rule of sevens” can provide general guidance for clinicians
assessing developmental capacity in pediatrics.
12/2/2019 ETHICS 133
• Children under the age of 7 are presumed to lack capacity,
children 7–13 years of age have an evolving sense of capacity
and should be evaluated on a case-by-case basis, and children
over 14 are presumed to have capacity unless evidence exists to
the contrary. example of a common pediatric intervention,
vaccination. A 4-year-old is unlikely to want to receive a shot,
but most all 4-year-old children will be unable to articulate a
meaningful decline, and may actively cry or hide in anticipation
of the intervention.
12/2/2019 ETHICS 134
• A 10-year-old is unlikely to want a shot, and may protest against it
because it may hurt, but will usually sit cooperatively for
administration of the immunization.
• A teenager may not want the shot, but realize that it is beneficial
and not protest, or they may articulate a reasonable response for
declining the immunization.
• It is important to remember that there will be older children who
lack developmental maturity to participate meaningfully and
younger children who have significant illness experience
prompting greater consideration of their opinion.
• If the child does not have a true choice in the final medical
decision, then they should not be offered a false choice.
12/2/2019 ETHICS 135
Evaluating Transfusion Refusals in Pediatric
Jehovah’s Witness Patients
• Refusals of transfusion should be evaluated in a manner similar to
other refusals.
• Providers should consider if alternative interventions (or
nonintervention) exist and evaluate the risks and benefits of the
treatment being refused against other proposed alternatives.
• It may be helpful to solicit the reason for the refusal and engage in
an open discussion to see if the refusing party can be gently
persuaded through assuasion of fears or misperceptions.
12/2/2019 ETHICS 136
• In our local experience, families have sometimes presented with
inaccurate information, such as vastly overestimating infection
risks associated with transfusion or expecting more immediate
(within days) benefit from the use of erythropoietin.
• If the intervention refused is not essential or can be deferred
without substantial risk, the refusal may be binding.
• In considering adolescent refusals, it is important to note the low
retention rate in the religious tradition and consider that the 16-
year-old refusing transfusion today, may be unlikely to hold the
same beliefs as an adult.
• This may be a consideration when there are high risks of harm to
the adolescent if the declination of transfusion is honored.
12/2/2019 ETHICS 137
• Families often understand that physicians have a fiduciary
responsibility to their patient, the child.
• Some families may be willing to sign an “acknowledgement
statement” which documents that the parents have been informed
that emergency transfusion will not be withheld regardless of
parental refusal to sign official transfusion consent.
• Acknowledgement statements may allow for the avoidance of state
intervention.
• Due to variability in legal precedent between states, we recommend
conferring with institutional legal counsel for appropriate language.
• In some circumstances it may not be possible to avoid state
intervention.
12/2/2019 ETHICS 138
• Some physicians believe that caring for a patient who refuses
standard care in the OR (for example, blood transfusion) puts them
in a situation of not being able to fully carry out their professional
responsibilities.
• The ASA has developed Guidelines for the Anesthesia Care of
Patients with Do- Not-Resuscitate Orders or Other Directives that
Limit Treatment.
• These guidelines should be applicable to surgeons as well.
• These guidelines state When an anesthetist finds the patient’s or
surgeon’s limitations of intervention decisions to be irreconcilable
with one’s own moral views, then the anesthetist should withdraw
in a nonjudgmental fashion, providing an alternative for care in a
timely fashion.
12/2/2019 ETHICS 139
12/2/2019 ETHICS 140
• Anesthetists spends longer time in an environment which is filled
with many hazards.
• There is a potential exposure to vapors from chemical radiations
and infectious agents.
• Their is also psychological stress.
Physical hazards
Infectious hazards
Psychological stress
12/2/2019 ETHICS 141
Physical hazards
• The effect of chronic exposure to anesthetic gases was not
recognized early.
• Reports on the effects of chronic exposure to anesthetic gases
have include;
• 1.Epidemiologic studies
• 2.Reproductive studies
• 3.Cellular studies
• 4.Studies on laboratory animals and humans
12/2/2019 ETHICS 142
1.Epidemiologic studies
• Were the first to suggest the possibility of hazards of exposure to
trace levels of anesthetics.
• There is high potential error in data collection and interpretation to
prevent this there should be an appropriate control group.
• Avoid misleading questions.
• Use medical records which provides reliable data.
12/2/2019 ETHICS 143
2.Cellular studies
• At clinically useful concentration, volatile anesthetics interfere
with cell division in a reversible manner.
• This may due to reduction in O2 intake by mitochondria.
• Although chronic exposure to trace level of N2O doesn’t affect
cellular activity, in abusers of N2O there will be inhibition of
methionine synthesis ;this will result in anemia and
polyneuropathy.
• Many studies have been performed in animals to asses the
carcinogenicity of anesthetics.
12/2/2019 ETHICS 144
Cellular studies…
• Corbett’s pilot work indicated that isoflorane produced hepatic
neoplasia when administered to mice during early stage of gestation
but a subsequent well controlled study disproved this
• Other studies in mice and rats found no carcinogenic effect of
halothane,N2O or enflurane.
• There is no proof that there is a relationship between anesthetic
exposure, cellular ultra structural changes and functional
abnormalities.
12/2/2019 ETHICS 145
3.Reproductive outcome
• Vaisman ,in 1975 surveyed 303 Russian anesthesiologists(193 men
and 110 women)
• The majority of them used N2O and ether without scavenging
waste anesthetic gases.
• The anesthesiologists reported increased incidence of headache,
irritability and fatigability.
• There were 18 abortions among 31 pregnant women in the survey.
12/2/2019 ETHICS 146
Reproductive …
• Although Vaisman’s study had no control group and done on
extremely small group of people, he finally concluded that these
occurrence were due to factors in the working environment
including;
chronic exposure to anesthetics
high level of emotional stress
excessive work load
12/2/2019 ETHICS 147
Reproductive…
• After the work of Vaisman, other investigators also began to survey
on anesthetic effects on reproductive system.
• One of the largest study was conducted by one committee of the
ASA.
• Questionnaires were sent to 49,585 OR personnel with potential
exposure to waste anesthetic gases whereas, 23,911 from the
American academic of pediatrics and the American nurse
association served as a control group.
12/2/2019 ETHICS 148
Reproductive outcome…
• The association finally concluded that, there is an increased risk
of abortion in women working in the operating area and
increased risk of congenital abnormalities in wives whose
husbands works in the operating room.
• But a Swedish study clearly demonstrates the inaccuracy
encountered when using mailed questionnaires.
12/2/2019 ETHICS 149
Reproductive outcome…
• All spontaneous abortions in the exposed group were accurately
documented in the responses to the questionnaires.
• But a review of hospital records revealed that one third of
spontaneous abortions went unreported.
• When verified data were analyzed, there was no statistically
significant difference b/n reproductive outcome in the exposed and
non-exposed.
12/2/2019 ETHICS 150
Infectious hazard
• Risk of infection is not unique to anesthesia.
• Every hospital personnel are at risk of infection.
• Anesthesia personnel can acquire infection during clerking the
patient, administering anesthesia and during post anesthesia care.
These includes;
Respiratory viruses
Viral hepatitis
HIV/AIDS
12/2/2019 ETHICS 151
I. Respiratory virus
• These are infections which are responsible for community acquired
infections.
• These viruses are usually transmitted by two routes.
• Small particle aerosols produced by coughing and sneezing.
• e.g. influenza viruses
12/2/2019 ETHICS 152
Respiratory viruses…
• Viruses transmitted by close person to person contact.
• e.g. Rhino virus
• II. Viral hepatitis
• hepatitis B virus (HBV) is a significant occupational hazard for
medical personnel who contact blood and blood products.
• Hepatitis B is highly infectious and the risk of transmission after
occupational exposure is higher than for HIV.
12/2/2019 ETHICS 153
Viral hepatitis…
• There are several modes of transmission of HBV that put
anesthesia personnel at risk for accidental infection.
• Percutaneous transmission can occur with contact with blood
products and body fluids.
• HBV is a hard virus that may be infectious for at least one week in
a dried blood.
12/2/2019 ETHICS 154
Viral hepatitis…
• An effective vaccine exists to prevent the transmission of hepatitis
B and all anesthetists should ensure that they are up to date with
their immunization schedule.
• Anesthetists in whom no antibodies are present and who suspect
exposure to hepatitis B should be immunized passively with
hepatitis B immunoglobulin and receive a series of three injections
of hepatitis B vaccine.
• Prior vaccination with seroconversion eliminates the need for
immunoglobulin.
12/2/2019 ETHICS 155
III.HIV/AIDS
• Risk of HIV infection is another infectious hazard.
• The risk of acquiring HIV after an occupational exposure to HIV-
infected blood is low.
• Epidemiological studies have indicated that the risk for HIV
transmission after percutaneous exposure to HIV-infected blood in
health care settings is 0.3%.
• After a mucocutaneous exposure, the risk is 0.03% and if intact
skin is exposed to HIV infected blood there is no risk of HIV
transmission
12/2/2019 ETHICS 156
HIV/AIDS…
• If occupational exposure does occur, the site of exposure should
be washed immediately with soap and water and the
occupational health department informed.
• Post-exposure prophylaxis has been shown to be maximally
effective if taken within an hour after an exposure, but benefit
may remain if commenced up to 2 weeks after exposure.
12/2/2019 ETHICS 157
Types of exposure with a significant
potential to transmit HIV
• Percutaneous injury from needles, instruments, bone fragments and
bites which break the skin
• Exposure of broken skin (eczema, cuts, abrasions) to contaminated
blood
• Exposure of mucous membranes including the conjunctivae
• Deep injury
• Visible blood on the device which caused the injury
• Injury with a needle or device which had been placed directly into
a source patients artery or vein
• Terminal HIV-related illness in the source patient
12/2/2019 ETHICS 158
HIV/AIDS…
• Exposure to larger volumes of blood, especially if the patients viral
load is high Because many patients may carry the AIDS virus and
not officially carry the diagnosis, anesthetists should consider all
patients to potentially have the disease
12/2/2019 ETHICS 159
Stress
• Stress is an inevitable factor in professional and personal life and
can lead to negative health effects, both mental and physical.
• Moderate levels of stress are an important driving factor in
optimizing performance, but prolonged and excessive levels of
stress, coupled with inadequate coping mechanisms, can lead to
decreased job satisfaction, impairment of decision making and
even suicide.
• Stress is a well recognized potential health hazards in the OR.
12/2/2019 ETHICS 160
Stress…
Causes of stress in anesthetists
Excessive work load
Process of difficult decisions
Night duty, fatigue
Interpersonal tension, relation
Lack of control of the work environment
Sleep deprivation and disruption of circadian rhythm
Continuing medical education and professional development
12/2/2019 ETHICS 161
Other occupational hazards
• Drug abuse and addiction
• Suicide
• Radiation
• Allergic reaction, etc..
12/2/2019 ETHICS 162
Sources of gas spillage in the OR
• Leakage of the scavenging system;
• During pediatric anesthesia
• A poorly fitting mask
• Un cuffed endotracheal tube
• Turning on the vaporizer before connecting breathing system to
the patient.
12/2/2019 ETHICS 163
Methods of reducing pollution with the volatile
anesthetics in the OR
• Use scavenging system
• Ventilate operating room well, especially after filling the vaporizer
with volatile agents
• Turn off vaporizer at end of surgery
• Select appropriate endotracheal tube size
• Fill vaporizer during night
12/2/2019 ETHICS 164
CASE-I
• 57 year old woman arrives in an Emergency Department comatose and bleeding
extensively (car accident)
• The ER physician feels she needs a blood transfusion to survive
• She has an unsigned and undated card in her wallet identifying her as a Jehovah’s Witness
and refusing blood products
• The court found him guilty of battery (assault) as he ignored her prior expressed wishes
(no blood transfusion)
• No one can speak for her
• The ER physician gives her blood in spite of the card
• She survived only to sue the doctor
• What are the issues here?
• What do you think of the doctor’s actions?
• What do you think of the court decision?
12/2/2019 ETHICS 165
CASE-II
• Acute perforated appendicitis which needs immediate
surgery but the patient refused to sign a consent which
was not documented was not operated and died next day.
What are the issues here?
What do you think should be the Doctor’s actions?
If the patient dies after the operation what is the liability?
12/2/2019 ETHICS 166
REFFERANCE
• Ethical Issues in Anesthesiology and Surgery, Barbara
G. Jericho Editor
• Clinical Anesthesia, Paul G. Barash, 8th edition
• Clinical ethics: a practical approach to ethical
decision in clinical medicine,7th edition 2010
12/2/2019 ETHICS 167
12/2/2019 ETHICS 168

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Professional ethics and anesthesia hazard

  • 1.
  • 2. Objectives At the end of this course you should be able to; Explain concepts of ethics and professional ethics Analyze medical ethics and law Describe the basic principles of ethics Explain role of ethics in medical research Avoid malpractice and negligence Discuss about informed consent Analyze the importance of anesthetic record Differentiate hazards of Anesthesia 12/2/2019 ETHICS 2
  • 3. SOME DEFINITIONS • Ethics – is simply the philosophical study of such concepts as Right and Wrong, Good and Bad, Rights and Duties. • Moral philosophy is equivalent to Ethics, but takes a Latin root of the word rather than a Greek one. • Applied Ethics is the application of Ethical theory to practical problems such as (for instance) Animal Rights, Environmental Issues, Legal issues. • Medical Ethics is a large sub-group of Applied Ethics. 12/2/2019 ETHICS 3
  • 4. Definition… • Meta-ethics is the consideration of basic questions about the underpinning of Ethics – questions like “Is there an Absolute Right or Wrong?”, and “Does Right and Wrong depend purely on individuals opinions?” • Medical Law – is the division of Law devoted to issues of Medical importance – such as Negligence, Consent, Confidentiality, End of Life Decisions. Medical law is often underpinned by Medical Ethics, but can often diverge quite markedly from ethical principles and can be quite pragmatic. • Common law is the law derived from Judge made decisions. 12/2/2019 ETHICS 4
  • 5. What is ethics? • Is the study of moral principles governing or influencing conduct(right and wrong). • Is the branch of knowledge concerned with moral principles. • Is the standard that govern the conduct of a person, especially a member of a profession. • is the value dimension of human decision making and behavior which includes rights, responsibilities and virtues and also good and bad. • Morality is study of moral standards and how they affect conduct. 12/2/2019 ETHICS 5
  • 6. Why study ethics? • The study of ethics is important to prepare learners to recognize difficult situations and to deal with them in rational and principled manner. To function at the highest professional level To avoid legal problems 12/2/2019 ETHICS 6
  • 7. What is Professional Ethics? • Professional ethics is the personal and corporate standards of behavior expected of the members of a particular profession. • Many professions that are trusted by the public to apply expert knowledge (doctors, engineers, surveyors, accountants and the like) have a Code of ethics which sets out their expectations of a member’s behavior and the boundaries within which members have to operate. 12/2/2019 ETHICS 7
  • 8. What is professional ethics?... • A Code of ethics( a document created to set the standards for ethically acceptable behavior) helps to clarify the profession’s values provides a reference point for decision making and can be used as a framework for discipline. • Most Codes of ethics are principles based, providing guidance as to the principles on which professional judgments and decisions should be based, rather than a rigid system of rules. • Professional ethics concerns one's conduct of behavior and practice when carrying out professional work. • System of conduct to guide the practice of a specific discipline. 12/2/2019 ETHICS 8
  • 9. Medical Ethics is the application of ethics to the practice of medicine. • Is the study of how a health professional might provide medical care to the best of their ability and for the maximum benefit of their patients or society. • Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. 12/2/2019 ETHICS 9
  • 10. Medical ethics and law • Medical ethics is closely related to law. • In most countries there are laws that specify how HPs are required to deal with ethical issues in patient care and research. • In addition the medical licensing and regulatory officials in each country can do and punish HPs for ethical violations. • But ethics and law are not identical. • Ethics describes higher standards of behavior than does the law and occasionally ethics requires that physicians disobey laws that demand unethical behavior. • Moreover laws differ significantly from one country to another while ethics is applicable across national boundaries. 12/2/2019 ETHICS 10
  • 11. Who decides what is ethical? • The answer to the question, “who decides what is ethical for people in general?” therefore varies from one society to another and even within the same society. • In liberal societies, individuals have greater deal of freedom to decide for themselves what is ethical although they will likely be influenced by their families, friends, religion ,media and other external sources. . 12/2/2019 ETHICS 11
  • 12. Who decides what is ethical?... • In more traditional societies, family and clan elders, religious authorities and political leader have greater role than individuals in determining what is ethical. • Despite these differences, it seems that most human beings can agree on some fundamental ethical principles, namely, the basic human rights proclaimed in the United Nations Universal Declaration of Human Rights and other widely accepted and officially endorsed documents. 12/2/2019 ETHICS 12
  • 13. Who decides what is ethical?... The human rights that are especially important for medical ethics include: all human beings are born free and equal in dignity and rights Right to life Right to freedom from discrimination, torture and cruel inhuman or degrading treatment Right to medical care Right to freedom of opinion and expression to equal access to public service in one’s country, and to medical care. 12/2/2019 ETHICS 13
  • 14. Who decides what is ethical for HPs? • In many not most, countries medical association have been responsible for developing and enforcing the applicable ethical standard. • Depending on the countries approach medical law, these standards may have legal status. 12/2/2019 ETHICS 14
  • 15. Who decides what is ethical for HPs?... • The ethical directives of medical association are greater in nature they can't deal with every situation that HPs might face in their medical practice. • In most situations HPs have to decide to themselves what is right way to act, but in making decision it is helpful to know what other HPs would do in similar situation. • Medical code of ethics and policy statements reflect a general consensus about the way HPs act and they should be followed unless there are good reasons for acting other wise. 12/2/2019 ETHICS 15
  • 16. Does medical ethics change? • There can be little doubt that some aspects of medical ethics have changed over the years. • Until recently physicians had the right and the duty to decide how patients should be treated and there was no obligation to obtain the patient’s informed consent. • In contrast, the 2005 version of the WMA Declaration on the Rights of the Patient begins with this statement: • “The relationship between HPs, their patients and broader society has undergone significant changes in recent times. 12/2/2019 ETHICS 16
  • 17. Does medical ethics change?... • While a physician should always act according to his/her conscience, and always in the best interests of the patient, equal effort must be made to guarantee patient autonomy and justice.” • Until recently, physicians generally considered themselves accountable only to themselves, to their colleagues in the medical profession and, for religious believers, to God. • Nowadays, they have additional accountabilities to their patients, to third parties such as hospitals and managed healthcare organizations, to medical licensing and regulatory authorities, and often to courts of law. 12/2/2019 ETHICS 17
  • 18. Does medical ethics change?... • Medical ethics has changed in other ways. • Participation in abortion was forbidden in medical code of ethics but now it is legalized in many countries including Ethiopia. 12/2/2019 ETHICS 18
  • 19. Does medical ethics differ from one country to another? • Just as medical ethics change over time in response to development in medical science and technology as well as in societal values so does differ country to country depending on these some factors; • On euthanasia, for example, there is a significant difference of opinion among national medical associations. • Some condemn it while others like Royal Duch Medical Association and some USA states support it. 12/2/2019 ETHICS 19
  • 20. Cont… • Physicians in some countries are confident that they will not be forced by their government to do any thing to do unethical while in other countries it may be difficult for them to meet their ethical obligation. • Most other issues are similar so the similarities are more than the differences. • The fundamental values of medical ethics such as compassion ,competence and autonomy along with physician experience and skills in all aspects of medicine and health care provide a sound basis for analyzing ethical issues in medicine and arriving at solutions that are in the best interests of individual patients and citizens and public health in general. 12/2/2019 ETHICS 20
  • 21. How do individuals decide what is ethical? • Many ethical issues arise in medical practice for which there is no guidance from medical associations. • Individuals are ultimately responsible for making their own ethical decisions and for implementing them. • Rational and non-rational • It is important to note that non-rational doesn’t mean irrational simply that it is to be distinguished from the systematic reflective use of reason in decision making. 12/2/2019 ETHICS 21
  • 22. Non-rational approaches • Obedience • Imitation • Feeling or desire • Intuition • habit 12/2/2019 ETHICS 22
  • 23. 1. Obedience • Common way of making ethical decision. • By those who work within authoritarian structures (e.g. the military,police,some religious organizations and many businesses). • Morality consists in following the rules and instructions of those in authority whether or not agree with them. 12/2/2019 ETHICS 23
  • 24. 2 . Imitation • is similar to obedience in that it subordinates one’s judgment about right and wrong to that of another person, in this case, a role model. • Morality consists in following examples of the role model. • Most common way of learning medical ethics by aspiring physicians with the role models being the senior consultants. 12/2/2019 ETHICS 24
  • 25. 3.Feeling or desire • Subjective approach to moral decision making behavior. • What Is right is what feels right satisfies one’s desire. • What is wrong is what feels wrong frustrates one’s desire. • The measure of morality is to be found within each individuals and can vary individuals to individuals and even within the some individual over time. 12/2/2019 ETHICS 25
  • 26. 4.Intuition • An immediate perception of the right way to act in situations. • It is similar to desire in that it is entirely subjective, how ever it differs because its location is in the mind than the will. • It is neither systematic nor reflexive but directs moral decisions through a simple flash of insight, • Like feeling and desire, it can vary greatly from one individual to an other and the some individual over time 12/2/2019 ETHICS 26
  • 27. 5.Habit • Is a very efficient method of moral decision making since there is no need to repeat a systematic decision making process each time a moral issue arises similar to one that has been dealt with previously. • However there are bad habits e.g. lying as well as good ones truth telling. • Moreover situations that appear similar may require significantly different decisions. 12/2/2019 ETHICS 27
  • 28. Rational approaches • Deontology • Consequentialism • Principlism • Virtue ethics 12/2/2019 ETHICS 28
  • 30. 1.Deontology • Involves a search for well founded rules that can serve as the basis for moral decisions. • An example of such rule is treat all people as equal, its foundation may religious or non religious. • Once the rules are established, they have to be applied in specific situations and there is often room for disagreement about what the rules require. 12/2/2019 ETHICS 30
  • 31. 2.Consequentialism • Bases ethical decision making on analysis of the likely consequences or out come of different choices and actions. • The end justifies the means. • The right action is the one that produces the best outcomes. • Decision making includes cost effectiveness and quality of life. 12/2/2019 ETHICS 31
  • 32. 3.Principlism • Ethical principles are the basis of making moral decision . • It applies in particular cases or situations in order to determine what is right to do taking in account both rules and consequences. • Four principles in particular; respect for autonomy,beneficence,nonmaleficence and justice have been identified as the most important for ethical decision making in medical practice. 12/2/2019 ETHICS 32
  • 33. 4.Virtue ethics Focuses less on decision making and more on the character of decision makers as reflected in their behavior.  A virtue is a type of moral excellence. Virtue is especially important for physicians to be compassionate. Other importance includes honest, prudence and dedication. Physicians who possess these virtues are more likely to make good decisions and to implement them in a good way. 12/2/2019 ETHICS 33
  • 34. Virtue ethics… Virtues; Compassion Honesty Prudence-knowing how to avoid embarrassment/distress Dedication 12/2/2019 ETHICS 34
  • 35. CONT… • Consequentialism and Deontology contrasted • The table below gives examples of practical ethical issues and contrasts Consequentialism and Deontology. Some situations seem to require a Consequentialist approach, and some seem to require a Deontological approach. 12/2/2019 ETHICS 35
  • 37. Basic principles of medical ethics • There are four basic principles of medical ethics. • Each addresses a value that arises in interactions b/n providers and patients. • These are; Autonomy/respect for persons Beneficence Non Maleficence Justice 12/2/2019 ETHICS 37
  • 38. 1.Respect for persons/autonomy • People should have control over their lives as much as possible because they are the only people who completely understand their chosen type of lifestyle. • People have the right to control what happens to their bodies. • This principle simply means that an informed, competent adult patient can refuse or accept treatments, drugs, and surgeries according to their wishes. • Respecting the decision making ability of autonomous persons; tell the truth respect patients decisions protect confidential information obtain consent for interventions help others make decisions when asked 12/2/2019 ETHICS 38
  • 39. Respect for persons/autonomy… • Autonomous persons • Autonomous choices Autonomy includes;  Freedom of will  Freedom of action  Free to choose and act • Privacy and confidentiality • Promotes informed consent 12/2/2019 ETHICS 39
  • 40. Autonomy in Research • Voluntary participation • Adequate information to make informed consent • Comprehension • Full disclosure of risks and benefits • No undue inducement • Voluntary termination • Continuing disclosure • Legally authorized representative • Culturally appropriate consent 12/2/2019 ETHICS 40
  • 41. 2.Beneficence • Acts of kindness or charity that go beyond strict obligation. • Guides health professionals to do good for patients to act always in the patients best interests. • All healthcare providers must strive to improve their patient’s health, to do the most good for the patient in every situation. • Common definition – acts of kindness or charity that go beyond strict obligation • To do good • Prevent evil or harm • Ought to remove evil or harm • Endeavor to benefit where possible 12/2/2019 ETHICS 41
  • 42. Beneficence… • In health care; an obligation to improve health • In research; Maximize benefits and minimize risks of possible harms • Balance risks and benefits • Promotes risk benefit analysis, post trial benefits etc… • Provide benefits and balance benefits against risks and harm • Protect and defend the rights of others • Prevent harm to others • Remove conditions that will cause others harm • Help disabled persons • Rescue persons in danger 12/2/2019 ETHICS 42
  • 43. 3.Nonmaleficence • The concept of non-maleficence is embodied by the phrase, "first, do no harm,". Many consider that should be the main or primary consideration that is more important not to harm your patient, than to do them good. • In every situation, healthcare providers should avoid causing harm to their patients. • Nonmaleficene is a similar concept to the principle of beneficence but deals with situations in which none of the outcomes of a treatment are likely to benefit the patient. • In this case, the HP should strive to do the list harm to the fewest people. • The decision making is left to the HP, rather than the patient or others. 12/2/2019 ETHICS 43
  • 44. Non-maleficence… • Avoidance of the causation of harm • Do not kill • Do not cause pain or suffering to others • Do not incapacitate others • Do not cause offense to others • Do not deprive others of the goods of life 12/2/2019 ETHICS 44
  • 45. 4.Justice • The principle of justice demands that HPs treat patients fairly. • Similar patients with similar illnesses should receive similar treatments. • Equal treatment – Different treatment requires justification (experience, age, deprivation, competence, merit, position, etc.) • What is deserved – People should be treated fairly, and should be given what they deserve in the sense of what they have earned. • Promotes issues on subject selections, what is owed them, how they are treated during and after research. • Fair distribution 12/2/2019 ETHICS 45
  • 46. Justice.. • Distribute benefits, risks, and costs fairly • To each an equal share • To each according to effort • To each according to need • To each according to contribution • To each according to merit 12/2/2019 ETHICS 46
  • 48. Research and Ethics • Introduction • Medicine is not an exact science. It does have many general principles that are valid most of the time, but every patient is different and what is an effective treatment for 90% of the population may not work for the other 10%. • Thus, medicine is inherently experimental. • Even the most widely accepted treatments need to be monitored and evaluated to determine whether they are effective for specific patients and, for that matter, for patients in general. 12/2/2019 ETHICS 48
  • 49. Introduction…. • All interventional medical treatments has resulted from research. • The development of new treatments, especially drugs, medical devices and surgical techniques are also the results of medical researches. 12/2/2019 ETHICS 49
  • 50. Historical ease of unethical research • In the first century BC Cleopatra was reputed to have had a number of her handmaidens impregnated and subsequently operated upon at certain times of gestation. • In 1932,the Japanese subjected tens of thousands of captured Chinese subjects to a number of horrifying experiments ,some of which involved live vivisection. 12/2/2019 ETHICS 50
  • 51. Unethical… • The Tuskegee syphilis study(1932); Was a 40 year project administered by the US public health service . • The government promised 400 men free treatment for bad blood which had become an epidemic in the country. • The study sample was made up of poor African and American men who were told that they had “bad blood". • They did not receive standard treatment for syphilis even when penicillin was available later during the study. 12/2/2019 ETHICS 51
  • 52. Unethical… • The willow Brook study; This study involved a group of children diagnosed with mental retardation ,who lived at the willow Brook state hospital in New York . • These innocent children were deliberately infected with hepatitis virus ;early subjects were fed extracts of stools from infected individuals and later subjects received injections of more purified virus preparations. 12/2/2019 ETHICS 52
  • 53. Unethical… • The tragic history of research abuse by Nazi doctors during World War II on Jews, gypsies and political prisoners. • Nazi doctors’ trials for medical experiments conducted among civilians and allied forces under the custody of the German Reich without subjects consent committed murders, brutalities, cruelties, tortures, atrocities and other inhuman acts. 12/2/2019 ETHICS 53
  • 54. Unethical… • Nazi medical experiments • High altitude experiments – conducted in low pressure chambers that approximate pressure at extremely high altitudes. • Freezing experiments – subjects remained in ice tanks for 3 hours, severely chilled and rewarmed. • Malaria experiments – infected healthy humans with infected mosquitoes. 12/2/2019 ETHICS 54
  • 55. • “Permissible medical experiment” • Nuremberg Code 12/2/2019 ETHICS 55
  • 56. Nuremberg code • The Nuremberg code was the first set of basic principles that must be observed in order to satisfy moral, ethical and legal concepts in conduct of human participants in research. • The main points included the statement that: • That animal experimentation should precede human experimentation. • “Voluntary consent of the human subject is absolutely essential.“ • All unnecessary physical and mental suffering and injury should be avoided; 12/2/2019 ETHICS 56
  • 57. Nuremberg code… • The degree of risk to participants should never exceed the humanitarian importance of the problem and should be minimized through proper preparations and • That participants should always be at liberty to withdraw from experiments. • The Code has been the model for many professional and governmental codes since the 1950s and has, in effect, served as the first international standard for the conduct of research. • The Nuremberg code was supplemented by the declaration of Helsinki in 1964. 12/2/2019 ETHICS 57
  • 58. Declaration of Helsinki • Originally adopted 1964. was developed by the World Medical Association for use by the medical community following dissemination of the Nuremberg Code. • 1st significant attempt by the medical community to regulate itself. • Like the Nuremberg Code, the Declaration made Informed consent a central requirement for ethical research while allowing for surrogate consent when the research participant is incompetent, physically or mentally incapable of giving consent, or a minor • Who are incompetent groups? 12/2/2019 ETHICS 58
  • 59. Declaration of Helsinki… • The Declaration also states that research with these groups should be conducted only when the research is necessary to promote the health of the population represented and when this research cannot be performed on legally competent persons. • It further states that when the subject is legally incompetent but able to give assent to decisions about participation in research, assent must be obtained in addition to the consent of the legally authorized representative. 12/2/2019 ETHICS 59
  • 60. Declaration of Helsinki… • The well being and interests of research participants must always prevail over interests of science and society. (code 5) • It is the duty of the medical professional to protect the life, privacy and dignity of the human subject. (Code 10) • Research must be reviewed by an independent committee (IRB) before it is conducted. (code 13). • The subjects must be volunteers and informed participants in the research project. (code 20). • Placebo acceptable only “where no proven prophylactic, diagnostic or therapeutic method exists”.(code 29). 12/2/2019 ETHICS 60
  • 61. CIOMS Guidelines • The Council for International Organizations of Medical Sciences (CIOMS) is an international, NGO, not for profit organization established jointly by WHO and UNESCO in 1949. • CIOMS serves the scientific interests of the international biomedical community in general and has been active in promulgating guidelines for the ethical conduct of research, among other activities. • CIOMS promulgated guidelines in 1993 entitled International Ethical Guidelines for Biomedical Research Involving Human Subjects. 12/2/2019 ETHICS 61
  • 62. CIOMS Guidelines … • The 15 guidelines address issues including informed consent, standards for external review, recruitment of participants, and more. • The Guidelines are general instructions and principles of ethical biomedical research. 12/2/2019 ETHICS 62
  • 63. Research in medical practice • All HPs make use of the results of medical research in their clinical practice. • To maintain their competence, HPs must keep up with the current research in their area of practice through continuing medical education/continuing professional development programs, medical journals and interaction with knowledgeable colleagues. • Even if they do not engage in research themselves, HPs must know how to interpret the results of research and apply them to their patients. • The most common method of research for practicing HPs is the clinical trial. 12/2/2019 ETHICS 63
  • 64. Research in medical practice… • Before a new drug can be approved by government mandated regulatory authorities, it must undergo extensive testing for safety and efficacy. • The process begins with laboratory studies followed by testing on animals. • If this proves promising the four phases of clinical research, are next: 12/2/2019 ETHICS 64
  • 65. Research in medical practice… • usually conducted on a relatively small number of healthy volunteers, who are often paid for their participation, is intended to determine what dosage of the drug is required to produce a response in the human body, how the body processes the drug, and whether the drug produces toxic or harmful effects. • • is conducted on a group of patients who have the disease that the drug is intended to treat. • Its goals are to determine whether the drug has any beneficial effect on the disease and has any harmful side effects. 12/2/2019 ETHICS 65
  • 66. Research in medical practice… • , • is the clinical trial, in which the drug is administered to a large number of patients and compared to another drug. • , takes place after the drug is licensed and marketed. • For the first few years, a new drug is monitored for side effects that did not show up in the earlier phases. • the pharmaceutical company is usually interested in how well the drug is being received by HPs who prescribe it and patients who take it. 12/2/2019 ETHICS 66
  • 67. Ethically acceptable research • An ethically accepted research is conducted under the major ethical principles. • 1.respect for autonomy • The involvement competent patients in research should be entirely of their own violation. • Participants are of free to withdraw their consent at any time and any reason. The three recognized components of consent are of fundamental importance; Voluntariness; the study subjects participation must be entirely based on their wish. Information; subjects should be informed; 12/2/2019 ETHICS 67
  • 68. Ethically accepted research… What is involved in taking part Why the research is being done What the risks might be the subject What the consequences of these risks might be Competence Is the subject competent enough to give consent 12/2/2019 ETHICS 68
  • 69. International guidelines • “Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient’s information, and to minimize the impact of the study on the subject’s mental integrity… and personality…” (Helsinki, 2000) • The investigator must establish secure safeguards of the confidentiality of subjects research data. • Subjects should be told the limits, legal or other, to the investigator’s ability to safeguard confidentiality and the possible consequences of breaches of confidentiality” (CIOMS, 2002) 12/2/2019 ETHICS 69
  • 70. Medical malpractice • Medical malpractice is improper, illegal or negligent professional procedure or treatment in the health care service. • Negligence is the most common medical malpractice. • Medical negligence is a failure to give proper care over patients. 12/2/2019 ETHICS 70
  • 71. Negligence • “Negligence is one type of tort (a wrongfull act) and malpractice is one type of negligence” • There are four elements to negligence. • They include: • duty, • breach, • injury, and • damages. 12/2/2019 ETHICS 71
  • 72. Negligence… • When the patient is seen preoperatively, and the anesthetist agrees to provide anesthesia care for the patient, a duty to the patient has been established. • the duty the anesthetist owes to the patient is to adhere to the standard of care for the treatment of the patient. • So once a HPs/patient relationship has been established, the HPs now owes the patient a certain duty of care. 12/2/2019 ETHICS 72
  • 73. Negligence… • • After this duty of care has been established, the HPs is required to exercise reasonable care and treat the patient as would other HPs in his field, following procedures and actions accepted by his peers. • In a malpractice action, expert witnesses will review the medical records of the case and determine whether the anesthetist acted in a reasonable and prudent manner in the specific situation and fulfilled his or her duty to the patient. • If they find that the anesthetist either did something that should not have been done or failed to do something that should have been done, then the duty to adhere to the standard of care has been breached. • Therefore, the second requirement for a successful suit will have been met. 12/2/2019 ETHICS 73
  • 74. Negligence… • the breach of duty may lead to the proximate cause of the injury. • If the odds are better than even that the breach of duty led, however circuitously, to the injury, this requirement is met. • • The victim must suffer damages, economic or non-economic, as a result of the injury. • three different types of damages. 12/2/2019 ETHICS 74
  • 75. Negligence… • General damages are those such as pain and suffering that directly result from the injury. • Special damages are those actual damages that are a consequence of the injury, such as medical expenses, lost income, and funeral expenses. • Punitive damages are intended to punish the physician for negligence that was reckless, wanton, fraudulent, or willful. • Punitive damages are exceedingly rare in medical malpractice cases. More likely in the case of gross negligence is a loss of the license to practice anesthesia. 12/2/2019 ETHICS 75
  • 76.  Informed consent is 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. Consent is based on the ethical principle of respect for persons. Acknowledge the person’s autonomy Protect those with diminished autonomy • Is permission to do something. • In medicine, consent allows an autonomous patient to define and protect his or her own interests and to control bodily privacy. • Autonomous individuals are considered as the best judges of their own best interests. 12/2/2019 ETHICS 76
  • 77. Consent… • The most important goal of informed consent is that the patient has an opportunity to be an informed participant in the health care decisions. • Decisions are made on the basis of a current understanding of the facts presented when evaluated in a logical manner ,with some insight shown in to the likely consequences of the decision. 12/2/2019 ETHICS 77
  • 78. 3 Components  Specific items for disclosure   Adapt the presentation to the subject’s needs  No threat of harm (coercion) AND no improper reward (undue influence) 12/2/2019 ETHICS 78
  • 79. Informed consent Protection from harm would protect patient from an “unwise choice” Protection of autonomy demands: full disclosure comprehension voluntary competence to consent 12/2/2019 ETHICS 79
  • 80. Competence In the context of this decision Standards of competence decision based on rational reasons decision leads to reasonable result capacity to make a decision • Competence judgments are “value laden” / weighed down 12/2/2019 ETHICS 80
  • 81. Comprehension of information • Comprehension-understanding the meaning of the information • Acceptance-believing that the information is true for them. • Appreciation-apply the information in a way that fosters understanding of how they will feel. 12/2/2019 ETHICS 81
  • 82. Voluntariness • Disclosure of alternate choices. • Influential vs.controlling inducements (influenced by circumstances) Coercion : - threat Indoctrination :- repeated instruction manipulation seduction rational persuasion : - reasoning 12/2/2019 ETHICS 82
  • 83. Incompetents • Patients competency can be affected either by age or medical condition. Children 16 and 17 year old children presumed to be competent to give consent for any treatment that would otherwise constitute a battery on them. Children under age of 16 are presumed to be incompetent to consent and to treatment. 12/2/2019 ETHICS 83
  • 84. Incompetents… • • Mental illness may impair a patients capacity to provide valid consent or refusal for an anesthetic intervention. • • Those with the greatest depth of faith refuse blood(blood product) transfusion, even if this lead to personal harm or death, believing that to receive transfusion will result in their eternal damnation. 12/2/2019 ETHICS 84
  • 85. Incompetents… • If the patient is determined to be incapacitated/incompetent to make health care decisions, a surrogate decision maker must speak for her. • There is a specific hierarchy of appropriate decision makers defined by state law. • If no appropriate surrogate decision maker is available, the physicians are expected to act in the best interest of the patient until a surrogate is found or appointed. 12/2/2019 ETHICS 85
  • 86. Incompetents… • In rare circumstances, when no surrogate can be identified, a guardian may have to be appointed by the court. • The patient's consent should only be presumed rather than obtained, in emergency situations when the patient is unconscious or incompetent and no surrogate decision maker is available, and the emergency interventions will prevent death or disability. 12/2/2019 ETHICS 86
  • 87. Waiving Consent Minimal risk studies without procedures that require consent. Waiving consent must not adversely affect subjects rights and welfare Telephone surveys Interviews Medical record review 12/2/2019 ETHICS 87
  • 88. Waiving Documentation of Consent • Minimal risk studies without procedures that require consent • When the only link to the subject is the consent document and that link may pose risk of breach of confidentiality. • E.g. Medical record review 12/2/2019 ETHICS 88
  • 89. Protection of Vulnerable Subjects • Vulnerable and Less Advantaged Persons; • Persons who are absolutely or relatively incapable of protecting their interests. • Insufficient power, intelligence, resources, strength or other needed attributes to protect their own interests through informed consent. • Each person when measured against the highest standards of capability is relatively vulnerable 12/2/2019 ETHICS 89
  • 90. Involvement of Vulnerable Subjects • “The proposed involvement of hospitalized patients, other institutionalized persons, or disproportionate numbers of racial or ethnic minorities or persons of low socioeconomic status should be justified.” • US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Institutional Review Boards: Report and Recommendation, 1978 12/2/2019 ETHICS 90
  • 91. Special Populations • Fetuses, pregnant women and human in vitro fertilization • Prisoners • Children 12/2/2019 ETHICS 91
  • 92. Why the anesthetists are liable for law suit ? • Liable= legally responsible • Suit=a process by which a court of law makes a decision to settle a disagreement. ANSWER Unrealistic expectation Poor rapport and poor communication Greed and or litigious society Poor quality of care 12/2/2019 ETHICS 92
  • 93. why do we study ethics and law To function at the highest professional level To avoid legal problems  Patient injury  Communication gap  minimum standard not fulfilled  Absence of License  Manipulating and mocked records  Not taking informed consent  Delayed referral  Absence from working area  Confidentiality  Not admitting mistakes (Apology 12/2/2019 ETHICS 93
  • 94. Anesthetic record • It is of little benefit in legal terms to have delivered good anesthesia care if it is impossible to identify each component of an anesthetic agent and when it was performed. • The record may have to be defended years after the case was completed, and case has been forgotten. • A general rule “if it was not written it was not done” When an incident occurs Facts should be documented Avoid using terms such as inadvertently that convey message of guilt or negligence Simply record the relavant facts about the incident like auscultatory findings, spinal level of somatic block 12/2/2019 ETHICS 94
  • 95. When an incident occurs • Facts should be documented • Avoid using terms such as inadvertently that convey message of guilt or negligence • Simply record the relavant facts about the incident like auscultatory findings, spinal level of somatic block • A frequent complaint is that there is no time to write notes while responding to a emergency situation • The solution is to write a perioperative note as soon as possible making reference to the approximate times of the events • such records are invaluable in distinguishing b/n a known complication and actual negligence 12/2/2019 ETHICS 95
  • 96. Respond appropriately an incident occurs • The anesthetist should continue to maintain professional contact with the patient during hospitalization after any incident that might be related to anesthesia. • Failure to do so might be interpret as a rejecting the patient. 12/2/2019 ETHICS 96
  • 97. Recognize malpractice prodromes • Receiving letters from a previous patient • Getting request for medical record from attorneys. • Response should not be hostile & goals are to explain why there is no liability for the claim to reduce the chance of a lawsuit being filed. • Direct correspondence with the patient should be kept to a minimum. • Best to work through the insurer or attorney. 12/2/2019 ETHICS 97
  • 98. Avoid vicarious liability • If anesthetist supervising anyone who is incompetent, supervision must be very close such as double checking preoperative findings, being present in the operating room during the entire case. • Do not agree to supervise more simultaneous cases than you can safely handle. • Issues of inadequate supervision and pt abandonment are hard to defend. 12/2/2019 ETHICS 98
  • 99. Notification of a lawsuit • An anesthetist may receive a notice of intent to sue within a specified period of time or may receive a summons. • There is finite period of time for a response to the summons and an assistance of an attorneys will be required. • Failure to respond within time will result in a directed decision for the plaintiff. • Anesthetist should avoid from discussing the case with anyone other than the attorney, as certain statements may be discoverable and used by the plaintiff during the trial. 12/2/2019 ETHICS 99
  • 100. CONT… • Access to the patient’s medical records is • permissible, but the temptation to add • notes must be avoided. • plaintiff’s attorney has already obtained • a copy of the medical record, and any • alteration after the notification of a • lawsuit will be introduced as evidence of • negligence. 12/2/2019 ETHICS 100
  • 101. Discovery • After the complaint is answered, both sides begin the process knows as ‘discovery’. • The purpose of discovery is to ascertain the “facts” of the case in preparation for trial. • It is the responsibility of the jury to decide which facts to believe. • So juries are, for this reason ,called “triers of fact” • A strength is a fact that is favorable and a weakness is a fact that is unfavorable. • The Medical record is the primary (FIRST) source of the facts. • A trier of the fact will believe what is written before believing what is said. • The notes were completed before any adverse outcome was known, so records are trusted. 12/2/2019 ETHICS 101
  • 102. CONT… • Second source of facts is the testimony of those who witnessed the event • Anesthetist may testify that something that was not recorded was done or seen. • It is not as believable as medical records because it relies upon specific recall of events that may have happened in the remote past. • Third source of facts is the usual practice pattern of the anesthetist. • If anesthetist has done something it must be because that is part of a routine. 12/2/2019 ETHICS 102
  • 103. CONT… • Fourth source of the fact • It is the expert witness testimony. • Expert are necessary because the subject of medicine is held to be beyond the knowledge or understanding of lay jurors. • Expert will review entire medical record 12/2/2019 ETHICS 103
  • 104. Order of credibility • 1) The anesthesia record and notes • 2) The expert’s interpretation • 3) Specific recall • 4) Usual and customary practice 12/2/2019 ETHICS 104
  • 105. Deposition testimony • The defendant anesthetist testimony is conducted by the plaintiff’s attorney. • The plaintiff attorney will attempt to uncover facts favorable to the plaintiff to ascertain the defense position on the issues in question. • Prior to the deposition, the defense attorney should meet the anesthetist to explain the conduct of the procedure, what to bring. 12/2/2019 ETHICS 105
  • 106. CONT… • There will be a series of questions . • There is need to speak slowly and clearly, understanding the questions, and waiting until the question is fully asked before answering . • Answer should be brief and to the point. • It helps to have a familiar with the dates of training, licence, and certifications. 12/2/2019 ETHICS 106
  • 107. Expert witness • Courts demand that witnesses be called so that the jury can benefit from the expertise and opinions of uninvolved parties. • Witnesses who are allowed to give opinions are called expert witness. 12/2/2019 ETHICS 107
  • 108. Malpractice suit To be successful in malpractice suit four elements must be proved by plain tiff attorney Duty –the anesthetist owed him or her a duty Breach of duty-anesthetist failed to fulfill his or her duty Causation-close causal relation ship exists between the acts of the anesthetist and the resultant injury Damages –the actual damages resulted because of the acts of the anesthetist. 12/2/2019 ETHICS 108
  • 109. Why anesthetists are sued ? Unrealistic expectations Poor rapport and poor communication Greed and or litigious society Poor quality of care What to do when sued ? Specific actions Don't discuss the case with any one Never alter any records Gather together all pertinent records Make notes recalling all events Cooperate fully with the attorney provided by the insurer or other bodies. 12/2/2019 ETHICS 109
  • 110. The Do’s • Review record • Analyze the case • Look for other relevant documents • Review literature • Identify experts in the field • Make a list of fact witness • Educate your attorney • The Don’ts • Don’t discuss the case with any one • Don’t change the records • Don’t accept any calls from other attorneys or patient or family members • Don’t talk to media 12/2/2019 ETHICS 110
  • 111. • Euthanasia - is the intentional bringing about of the death of a patient (by killing or allowing to die) where this is done for the patient's own sake. • Note the three parts to the definition • Intentional • Killing or allowing to die • Done for the patient's sake • Active Euthanasia - is taking of some action in order to cause death, for the patient's own sake • Passive Euthanasia - is omitting to take some action which would prevent or avert death, for the patient's own sake 12/2/2019 ETHICS 111
  • 112. CONT… • A patient who refuses treatment (even if that refusal may shorten the life of the patient) This sounds like Passive Euthanasia, as defined above. • However, it is d/t even though the difference is subtle. In Passive Euthanasia the patient says, "Please don't give me Treatment X, because I want to die". • In Refusal of Treatment, the patient says "Please don't give me Treatment X, it's my right to refuse treatment, and I'll take my chances" (which may or may not include death) The Doctor's reply is d/t too - in Passive Euthanasia he may say "It's my duty to prevent death, I can't go along with this plan - you must have the treatment" (or he may say "Okay, I agree you’ve had enough suffering" In Refusal of Treatment, he says, "Well, it's your right to refuse treatment if you wish, but I need to advise you that I strongly recommend the treatment I suggested" 12/2/2019 ETHICS 112
  • 114. Do not resuscitate’orders • Again, no statutory law exists. The guidelines that inform clinical practice in the UK are those provided by the BMA, Royal College of Nursing and the UK Resuscitation Council joint statement of 2002. • This may be summarized as follows: • Principles • support for patients and people close to them, and effective, sensitive communication are essential; decisions must be based on the individual patient’s circumstances and reviewed regularly; information about CPR and the chances of a successful outcome needs to be realistic. 12/2/2019 ETHICS 114
  • 115. CONT… • In emergencies • If no advance decision has been made or is known, CPR should be attempted unless: • the patient has refused CPR; • the patient is clearly in the terminal phase of illness; • the burdens of the treatment outweigh the benefits. • Advance decision-making • competent patients should be involved in discussions about attempting CPR unless they indicate that they do not want to be; where patients lack competence to participate, people close to them can be helpful in reflecting their views. 12/2/2019 ETHICS 115
  • 116. CONT… • Legal issues • patient’s rights under the HRA must be taken into account in decision-making; neither patients nor relatives can demand treatment which the health care team judges to be inappropriate, but all efforts will be made to accommodate wishes and preferences; in England, Wales and Northern Ireland, relatives and people close to the patient are not entitled in law to take health care decisions for the patient; in Scotland, adults may appoint a health care proxy to give consent to medical treatment; health professionals need to be aware of the law in relation to decision-making for children and young people. 12/2/2019 ETHICS 116
  • 119. Causes of action most relevant to anesthetist • Medical negligence:- Breech of a duty of a standard of care causing harm • Wrongful death:- One that occurs earlier that it would have otherwise. • If negligence causes death, survivors may sue for damages • Lack of informed consent Obligation to provide information material to a reasonable person • Abandonment-- Obligation to provide continuity of care once a physician assumes responsibility for the patient 12/2/2019 ETHICS 119
  • 120. • Vicarious liability – Obligation for reasonable oversight of those working for the physician • Loss of chance of recovery or survival- The patient must show that recovery was likely except for the action of the physician • Battery- Touching a person without express or implied consent. There is no need for the plaintiff to prove harm in battery cases • Assault -The attempt to touch another person. • There is no need to prove actual harm 12/2/2019 ETHICS 120
  • 121. • Jehovah’s Witnesses are an international religious organization and comprise approximately 0.6–0.8% of the adult population in the US with the greatest percentage residing in the South (36%) or West (29%). • Interestingly, the majority of Jehovah’s Witnesses (63%) have no children. • However, Jehovah’s Witnesses have the lowest retention rate of any religious group with only 37% of individuals raised in the faith as children keeping this religious affiliation into adulthood 12/2/2019 ETHICS 121
  • 122. CONT… • Though JWs started in 1870, it was not until 1945 that a ban on blood transfusions was placed for JW’s. • This ban on blood transfusions was based on quotes from the Bible, especially the following: ( New World Translation of the Holy Scriptures – 2013 Revision ). • Genesis 9:3 - …. Only flesh with its life – with its blood – you must not eat • Leviticus 17:10–12 - ‘If any man of the house of Israel or any foreigner who is residing • in your midst eats any sort of blood, I will certainly set my face against the one who is eating • the blood, and I will cut him off from among his people (Leviticus 17:10). For the life • of the fl esh is in the blood, and I myself have given it on the altar for you to make atonement • for yourselves, because it is the blood that makes atonement by means of the life in it • (Leviticus 17:11). That is why I have said to the Israelites: “None of you should eat blood, • and no foreigner who is residing in your midst should eat blood” (Leviticus 17:12). • Acts 15:28–29 - …to keep abstaining from things sacrificed to idols and from blood… 12/2/2019 ETHICS 122
  • 123. • A 1951 Watchtower article explained the reasoning that led to this ban on blood • transfusion: “when sugar solutions are given intravenously, it is called intravenous feeding. …The transfusion is feeding the patient blood and …(the patient) is eating it (blood) through his veins”. 12/2/2019 ETHICS 123
  • 124. • It is a common misconception that if you give a JW blood against his or her will, then the JW is still subject to eternal damnation. • Another misconception is that if a JW accepts blood then he or she, too, would be subject to eternal damnation with no chance of repentance. • Neither of these is true. According to an e-mail communication with the JW lead office: 12/2/2019 ETHICS 124
  • 125. • In fact, since 2000 JWs are not “disfellowshipped” for accepting blood. • JWs are considered to have voluntarily “disassociated” from the Church. • This means that if a JW does repent he or she can remain in the fold. • In order to keep up with advances in medicine (for example, renal dialysis; cardiopulmonary bypass; blood harvesting including cell saver (cell salvage), acute normovolemic hemodilution and autologous blood donation; and organ transplant), new guidelines for JWs have been developed to aid members in addressing these clinical situations. 12/2/2019 ETHICS 125
  • 126. • “A forced blood transfusion would not be viewed as a sin. • Also, if under extreme pressure & while experiencing undue stress a JW was to compromise their belief and accept blood transfusions, in other words, if they caved in at a moment of spiritual weakness yet still held to their beliefs, that individual would not be ostracized by the JW community, rather, kindness would be shown and pastoral help offered. Nevertheless, a forced transfusion or a compromise with one's conscience may leave the patient with deep emotional scars.” 12/2/2019 ETHICS 126
  • 127. • The ethical and legal right of capacitated adults to make medical decisions for themselves is well-established. • Autonomous decision making provides adults with the leeway to make authentic choices consistent with their beliefs and values. • If an adult patient makes a “bad decision,” the clinician may confirm capacity and attempt to use gentle persuasion to redirect the patient, but little precedent exists to override their refusal. • It may even be considered battery if consent is not obtained from a capacitated adult patient and his or her known preferences are overridden. 12/2/2019 ETHICS 127
  • 128. • When adult patients are unable to make medical decisions on their own behalf, clinicians try to identify a person to act as the patient’s “surrogate” and make decisions as his or her proxy. • In other words, clinicians ask the surrogate to make decisions based on the patient’s previously expressed wishes (if known), or to make decisions consistent with the patient’s known values and interests. • In pediatrics, children have developing and evolving decisional capacity as well as beliefs and values. • Parental authority and familial autonomy over their developing, vulnerable child creates a unique dynamic that is different from the moral space in which surrogates make medical decisions. 12/2/2019 ETHICS 128
  • 129. • Infants and children lack the ability to make autonomous medical decisions and • therefore parents (or legal guardians) are presumed to have a liberty interest in the “care, custody, and management” of their children. • Furthermore, as children age and mature they are able to play an increasing role in the medical decision making process creating a triangle of decision making between patient, parent, and provider, which may raise additional complexities. • While parents are allowed broad discretion in medical decision making, this right is not absolute. • As was noted in the case of Prince v Massachusetts , “…Parents may be free to become martyrs themselves. • But it does not follow they are free, in identical circumstances, to make martyrs of their children before they have reached the age of full and legal discretion 12/2/2019 ETHICS 129
  • 130. • The “best interest of the child” standard is based on the ethical principles of beneficence, or the “moral obligation to contribute to the good of others”. • In the context of medical decision making, it aspires to identify the medical care (decision) that is in the best interest of the child. • When parental decision making aligns with a proposed medical therapy, the care is often delivered without deliberate consideration of this ethical standard. 12/2/2019 ETHICS 130
  • 131. • When differences of opinion exist, the standard may be invoked to substitute the views of a third party (the physician, the courts) over the views of the parents. • One expects that most parents do not seek to make decisions they perceive as harmful, so why do clinicians and families sometimes collide over what interventions are best for the pediatric patient? • The best interest standard and the evaluation of the benefits and harms of alternative medical pathways are inherently subjective, value-laden judgments. • Consider a patient with osteosarcoma – based on tumor location and the response to chemotherapy, the oncologist and surgeon may recommend amputation rather than a limb sparing technique, but after evaluation of the information and consideration of their personal preferences and beliefs, the family may still elect to pursue limb- sparing. 12/2/2019 ETHICS 131
  • 132. • The teenager may feel that it is in his long-term best interest to not have a prosthesis and is willing to accept any increased risks associated with declining amputation (amputation being what the physicians consider to be his present day best interest). • Finally, children are highly dependent on their parents who bear the burden of their care. • Parents are likely to consider familial needs – this is the balancing and rank ordering of the interests of the parents, siblings, and their child who is the patient in order to reach a determination of what is the best medical decision 12/2/2019 ETHICS 132
  • 133. Assent and Children’s Role in Medical Decision Making • As children mature, they develop an increasing ability to evaluate proposed medical interventions and consider the risks and benefits of the alternatives. • Children are not treated as rational, autonomous adults but allowed to participate in decisions in a manner consistent with their developing capacity. • Meaningful pediatric assent, which is less stringent than consent, allows children the opportunity to state their preferences within the context of their developmental abilities and desire to participate. • It may be helpful to consider the practical • The “rule of sevens” can provide general guidance for clinicians assessing developmental capacity in pediatrics. 12/2/2019 ETHICS 133
  • 134. • Children under the age of 7 are presumed to lack capacity, children 7–13 years of age have an evolving sense of capacity and should be evaluated on a case-by-case basis, and children over 14 are presumed to have capacity unless evidence exists to the contrary. example of a common pediatric intervention, vaccination. A 4-year-old is unlikely to want to receive a shot, but most all 4-year-old children will be unable to articulate a meaningful decline, and may actively cry or hide in anticipation of the intervention. 12/2/2019 ETHICS 134
  • 135. • A 10-year-old is unlikely to want a shot, and may protest against it because it may hurt, but will usually sit cooperatively for administration of the immunization. • A teenager may not want the shot, but realize that it is beneficial and not protest, or they may articulate a reasonable response for declining the immunization. • It is important to remember that there will be older children who lack developmental maturity to participate meaningfully and younger children who have significant illness experience prompting greater consideration of their opinion. • If the child does not have a true choice in the final medical decision, then they should not be offered a false choice. 12/2/2019 ETHICS 135
  • 136. Evaluating Transfusion Refusals in Pediatric Jehovah’s Witness Patients • Refusals of transfusion should be evaluated in a manner similar to other refusals. • Providers should consider if alternative interventions (or nonintervention) exist and evaluate the risks and benefits of the treatment being refused against other proposed alternatives. • It may be helpful to solicit the reason for the refusal and engage in an open discussion to see if the refusing party can be gently persuaded through assuasion of fears or misperceptions. 12/2/2019 ETHICS 136
  • 137. • In our local experience, families have sometimes presented with inaccurate information, such as vastly overestimating infection risks associated with transfusion or expecting more immediate (within days) benefit from the use of erythropoietin. • If the intervention refused is not essential or can be deferred without substantial risk, the refusal may be binding. • In considering adolescent refusals, it is important to note the low retention rate in the religious tradition and consider that the 16- year-old refusing transfusion today, may be unlikely to hold the same beliefs as an adult. • This may be a consideration when there are high risks of harm to the adolescent if the declination of transfusion is honored. 12/2/2019 ETHICS 137
  • 138. • Families often understand that physicians have a fiduciary responsibility to their patient, the child. • Some families may be willing to sign an “acknowledgement statement” which documents that the parents have been informed that emergency transfusion will not be withheld regardless of parental refusal to sign official transfusion consent. • Acknowledgement statements may allow for the avoidance of state intervention. • Due to variability in legal precedent between states, we recommend conferring with institutional legal counsel for appropriate language. • In some circumstances it may not be possible to avoid state intervention. 12/2/2019 ETHICS 138
  • 139. • Some physicians believe that caring for a patient who refuses standard care in the OR (for example, blood transfusion) puts them in a situation of not being able to fully carry out their professional responsibilities. • The ASA has developed Guidelines for the Anesthesia Care of Patients with Do- Not-Resuscitate Orders or Other Directives that Limit Treatment. • These guidelines should be applicable to surgeons as well. • These guidelines state When an anesthetist finds the patient’s or surgeon’s limitations of intervention decisions to be irreconcilable with one’s own moral views, then the anesthetist should withdraw in a nonjudgmental fashion, providing an alternative for care in a timely fashion. 12/2/2019 ETHICS 139
  • 141. • Anesthetists spends longer time in an environment which is filled with many hazards. • There is a potential exposure to vapors from chemical radiations and infectious agents. • Their is also psychological stress. Physical hazards Infectious hazards Psychological stress 12/2/2019 ETHICS 141
  • 142. Physical hazards • The effect of chronic exposure to anesthetic gases was not recognized early. • Reports on the effects of chronic exposure to anesthetic gases have include; • 1.Epidemiologic studies • 2.Reproductive studies • 3.Cellular studies • 4.Studies on laboratory animals and humans 12/2/2019 ETHICS 142
  • 143. 1.Epidemiologic studies • Were the first to suggest the possibility of hazards of exposure to trace levels of anesthetics. • There is high potential error in data collection and interpretation to prevent this there should be an appropriate control group. • Avoid misleading questions. • Use medical records which provides reliable data. 12/2/2019 ETHICS 143
  • 144. 2.Cellular studies • At clinically useful concentration, volatile anesthetics interfere with cell division in a reversible manner. • This may due to reduction in O2 intake by mitochondria. • Although chronic exposure to trace level of N2O doesn’t affect cellular activity, in abusers of N2O there will be inhibition of methionine synthesis ;this will result in anemia and polyneuropathy. • Many studies have been performed in animals to asses the carcinogenicity of anesthetics. 12/2/2019 ETHICS 144
  • 145. Cellular studies… • Corbett’s pilot work indicated that isoflorane produced hepatic neoplasia when administered to mice during early stage of gestation but a subsequent well controlled study disproved this • Other studies in mice and rats found no carcinogenic effect of halothane,N2O or enflurane. • There is no proof that there is a relationship between anesthetic exposure, cellular ultra structural changes and functional abnormalities. 12/2/2019 ETHICS 145
  • 146. 3.Reproductive outcome • Vaisman ,in 1975 surveyed 303 Russian anesthesiologists(193 men and 110 women) • The majority of them used N2O and ether without scavenging waste anesthetic gases. • The anesthesiologists reported increased incidence of headache, irritability and fatigability. • There were 18 abortions among 31 pregnant women in the survey. 12/2/2019 ETHICS 146
  • 147. Reproductive … • Although Vaisman’s study had no control group and done on extremely small group of people, he finally concluded that these occurrence were due to factors in the working environment including; chronic exposure to anesthetics high level of emotional stress excessive work load 12/2/2019 ETHICS 147
  • 148. Reproductive… • After the work of Vaisman, other investigators also began to survey on anesthetic effects on reproductive system. • One of the largest study was conducted by one committee of the ASA. • Questionnaires were sent to 49,585 OR personnel with potential exposure to waste anesthetic gases whereas, 23,911 from the American academic of pediatrics and the American nurse association served as a control group. 12/2/2019 ETHICS 148
  • 149. Reproductive outcome… • The association finally concluded that, there is an increased risk of abortion in women working in the operating area and increased risk of congenital abnormalities in wives whose husbands works in the operating room. • But a Swedish study clearly demonstrates the inaccuracy encountered when using mailed questionnaires. 12/2/2019 ETHICS 149
  • 150. Reproductive outcome… • All spontaneous abortions in the exposed group were accurately documented in the responses to the questionnaires. • But a review of hospital records revealed that one third of spontaneous abortions went unreported. • When verified data were analyzed, there was no statistically significant difference b/n reproductive outcome in the exposed and non-exposed. 12/2/2019 ETHICS 150
  • 151. Infectious hazard • Risk of infection is not unique to anesthesia. • Every hospital personnel are at risk of infection. • Anesthesia personnel can acquire infection during clerking the patient, administering anesthesia and during post anesthesia care. These includes; Respiratory viruses Viral hepatitis HIV/AIDS 12/2/2019 ETHICS 151
  • 152. I. Respiratory virus • These are infections which are responsible for community acquired infections. • These viruses are usually transmitted by two routes. • Small particle aerosols produced by coughing and sneezing. • e.g. influenza viruses 12/2/2019 ETHICS 152
  • 153. Respiratory viruses… • Viruses transmitted by close person to person contact. • e.g. Rhino virus • II. Viral hepatitis • hepatitis B virus (HBV) is a significant occupational hazard for medical personnel who contact blood and blood products. • Hepatitis B is highly infectious and the risk of transmission after occupational exposure is higher than for HIV. 12/2/2019 ETHICS 153
  • 154. Viral hepatitis… • There are several modes of transmission of HBV that put anesthesia personnel at risk for accidental infection. • Percutaneous transmission can occur with contact with blood products and body fluids. • HBV is a hard virus that may be infectious for at least one week in a dried blood. 12/2/2019 ETHICS 154
  • 155. Viral hepatitis… • An effective vaccine exists to prevent the transmission of hepatitis B and all anesthetists should ensure that they are up to date with their immunization schedule. • Anesthetists in whom no antibodies are present and who suspect exposure to hepatitis B should be immunized passively with hepatitis B immunoglobulin and receive a series of three injections of hepatitis B vaccine. • Prior vaccination with seroconversion eliminates the need for immunoglobulin. 12/2/2019 ETHICS 155
  • 156. III.HIV/AIDS • Risk of HIV infection is another infectious hazard. • The risk of acquiring HIV after an occupational exposure to HIV- infected blood is low. • Epidemiological studies have indicated that the risk for HIV transmission after percutaneous exposure to HIV-infected blood in health care settings is 0.3%. • After a mucocutaneous exposure, the risk is 0.03% and if intact skin is exposed to HIV infected blood there is no risk of HIV transmission 12/2/2019 ETHICS 156
  • 157. HIV/AIDS… • If occupational exposure does occur, the site of exposure should be washed immediately with soap and water and the occupational health department informed. • Post-exposure prophylaxis has been shown to be maximally effective if taken within an hour after an exposure, but benefit may remain if commenced up to 2 weeks after exposure. 12/2/2019 ETHICS 157
  • 158. Types of exposure with a significant potential to transmit HIV • Percutaneous injury from needles, instruments, bone fragments and bites which break the skin • Exposure of broken skin (eczema, cuts, abrasions) to contaminated blood • Exposure of mucous membranes including the conjunctivae • Deep injury • Visible blood on the device which caused the injury • Injury with a needle or device which had been placed directly into a source patients artery or vein • Terminal HIV-related illness in the source patient 12/2/2019 ETHICS 158
  • 159. HIV/AIDS… • Exposure to larger volumes of blood, especially if the patients viral load is high Because many patients may carry the AIDS virus and not officially carry the diagnosis, anesthetists should consider all patients to potentially have the disease 12/2/2019 ETHICS 159
  • 160. Stress • Stress is an inevitable factor in professional and personal life and can lead to negative health effects, both mental and physical. • Moderate levels of stress are an important driving factor in optimizing performance, but prolonged and excessive levels of stress, coupled with inadequate coping mechanisms, can lead to decreased job satisfaction, impairment of decision making and even suicide. • Stress is a well recognized potential health hazards in the OR. 12/2/2019 ETHICS 160
  • 161. Stress… Causes of stress in anesthetists Excessive work load Process of difficult decisions Night duty, fatigue Interpersonal tension, relation Lack of control of the work environment Sleep deprivation and disruption of circadian rhythm Continuing medical education and professional development 12/2/2019 ETHICS 161
  • 162. Other occupational hazards • Drug abuse and addiction • Suicide • Radiation • Allergic reaction, etc.. 12/2/2019 ETHICS 162
  • 163. Sources of gas spillage in the OR • Leakage of the scavenging system; • During pediatric anesthesia • A poorly fitting mask • Un cuffed endotracheal tube • Turning on the vaporizer before connecting breathing system to the patient. 12/2/2019 ETHICS 163
  • 164. Methods of reducing pollution with the volatile anesthetics in the OR • Use scavenging system • Ventilate operating room well, especially after filling the vaporizer with volatile agents • Turn off vaporizer at end of surgery • Select appropriate endotracheal tube size • Fill vaporizer during night 12/2/2019 ETHICS 164
  • 165. CASE-I • 57 year old woman arrives in an Emergency Department comatose and bleeding extensively (car accident) • The ER physician feels she needs a blood transfusion to survive • She has an unsigned and undated card in her wallet identifying her as a Jehovah’s Witness and refusing blood products • The court found him guilty of battery (assault) as he ignored her prior expressed wishes (no blood transfusion) • No one can speak for her • The ER physician gives her blood in spite of the card • She survived only to sue the doctor • What are the issues here? • What do you think of the doctor’s actions? • What do you think of the court decision? 12/2/2019 ETHICS 165
  • 166. CASE-II • Acute perforated appendicitis which needs immediate surgery but the patient refused to sign a consent which was not documented was not operated and died next day. What are the issues here? What do you think should be the Doctor’s actions? If the patient dies after the operation what is the liability? 12/2/2019 ETHICS 166
  • 167. REFFERANCE • Ethical Issues in Anesthesiology and Surgery, Barbara G. Jericho Editor • Clinical Anesthesia, Paul G. Barash, 8th edition • Clinical ethics: a practical approach to ethical decision in clinical medicine,7th edition 2010 12/2/2019 ETHICS 167

Editor's Notes

  1. Corporate= collective
  2. Clan = a group of people all descended from a common ancester
  3. Euthanasia= the practice of intentionally and painlessly killing a human being.
  4. Obedience=willing to comply with the instruction of those in authority
  5. Iatrogenic= induced by action of the physician.
  6. VIVISECTION= THE ACT OF CUTTING ORGANIZM FOR THE PURPOSE OF PATHOLOGICAL SCIENTIFIC INVESTIGATION Impregnate= to cause to become pregnant Handmaidens= female servants
  7. VIVISECTION= THE ACT OF CUTTING ORGANIZM FOR THE PURPOSE OF PATHOLOGICAL SCIENTIFIC INVESTIGATION Impregnate= to cause to become pregnant Handmaidens= female servants The purpose of this study was to observe the natural history of untreated syphilis
  8. Determines how long human being can servive in freezing water
  9. is a set of research ethics principle for human experimentation created as are sult of the nuremberg trials at the end of the second world war.
  10. Formal statement of ethical principles published by the WMA to guide the protection of human participations in medical research
  11. An early symtom warning of the onset of a disease
  12. BMA= BRITISH MEDICAL ASSOCIATION
  13. HRA (HEALTH REIMBURSMENT ARRANGEMENT)
  14. Vicarious = done on behalf of others
  15. Leviticus=orit thelewawiyan
  16. Repentance= a feeling of regret for doing wrong or sinning
  17. Proxy= an agent Surrogate= a person act as substitute
  18. Persue=to follow
  19. Persuade= convince to agree Assuasion= relief
  20. Fiduciary= one who hold a thing in trust for another.