Professional ethics and Anesthesia hazards

AKSUM UNIVERSITY
COLLEGE OF HEALTH SCIENCES
DEPARTMENT OF ANESTHESIOLOGY
PROFESSIONAL ETHICS AND ANESTHESIA
HAZARDS FOR YEAR III ANESTHESIOLOGY
STUDENTS
BY: Abraham T.
1/4/2018 1

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
Objectives
1/4/2018 2

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.
1/4/2018 3

What is ethics?...
 Morality 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.
1/4/2018 4

Why study ethics?
 As long as the practitioner is knowledgeable and
skilful, ethics doesn’t matter.
 Medical ethics is learnt by observing how seniors act
not from books or lectures.
 The study of ethics is important to prepare learners to
recognize difficult situations and to deal with them in
rational and principled manner.
1/4/2018 5

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. 1/4/2018 6

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. 1/4/2018 7

What is professional ethics?...
 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.
1/4/2018 8

Medical Ethics
 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.
1/4/2018 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.
1/4/2018 10

Medical ethics and law….
 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.
1/4/2018 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. .
1/4/2018 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.
1/4/2018 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.
1/4/2018 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.
1/4/2018 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.
1/4/2018 16

Who decides what is ethical for HPs?...
 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.
1/4/2018 17

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.
1/4/2018 18

Does medical ethics
change?...
 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. 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.”1/4/2018 19

Does medical ethics
change?...
 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.
1/4/2018 20

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.
1/4/2018 21

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.
1/4/2018 22

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.
1/4/2018 23

Cont…
 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.
1/4/2018 24

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. 1/4/2018 25

Non-rational approaches
 Obedience
 Imitation
 Feeling or desire
 Intuition
 habit
1/4/2018 26

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.
1/4/2018 27

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.
1/4/2018 28

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.
1/4/2018 29

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
1/4/2018 30

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.
1/4/2018 31

Rational approaches
 Deontology
 Consequentialism
 Principlism
 Virtue ethics
1/4/2018 32

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.
1/4/2018 33

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.
1/4/2018 34

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.
1/4/2018 35

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. 1/4/2018 36

Virtue ethics…
Virtues;
 Compassion
 Honesty
 Prudence-knowing how to avoid
embarrassment/distress
 Dedication
1/4/2018 37

Basic principles of medical
ethics
 There are four basic principles of medical ethics.
 Each addresses a value that arises in interactions
between providers and patients.
These are;
 Autonomy/respect for persons
 Beneficence
 Non Maleficence
 Justice
1/4/2018 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.
1/4/2018 39

Respect for persons/autonomy…
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
1/4/2018 40

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
1/4/2018 41

Autonomy in Research
 Voluntary participation
 Adequate information to make informed
consent
 Comprehension
 Full disclosure of risks and benefits
 No undue inducement
1/4/2018 42

Autonomy in Research…
 Voluntary termination
 Continuing disclosure
 Legally authorized representative
 Culturally appropriate consent
1/4/2018 43

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.
1/4/2018 44

Beneficence…
 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
1/4/2018 45

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…
1/4/2018 46

Beneficence…
 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
1/4/2018 47

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.
1/4/2018 48

Nonmaleficence…
 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.
1/4/2018 49

Nonmaleficence…
 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
1/4/2018 50

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.)
1/4/2018 51

Justice…
 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
1/4/2018 52

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
1/4/2018 53

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. 1/4/2018 54

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.
1/4/2018 55

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.
1/4/2018 56

Unethical…
 In 1932,the Japanese subjected tens of
thousands of captured Chinese subjects
to a number of horrifying experiments
,some of which involved live vivisection.
1/4/2018 57

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.
1/4/2018 58

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. 1/4/2018 59

Unethical…
 The tragic history of research abuse by
Nazi doctors during World War II on
Jews, gypsies and political prisoners.
1/4/2018 60

Unethical…
 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.
1/4/2018 61

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.
1/4/2018 62

Low pressure experiment
1/4/2018 63

Freezing Experiment
1/4/2018 64

Unethical…
 Bone, nerve, muscle transplantation
from one person to another.
 Sea water experiment – subjects
deprived of food and given chemically
treated water.
 Sterilization of subjects by means of x
ray, surgery and drugs.
 Spotted fever (typhus) germs infected
healthy subjects to develop vaccine.
1/4/2018 65

Unethical…
 Poison mixed with food or subjects shot
with poison bullets to investigate effects
of various poisons.
 Incendiary bomb experiments – Burns
inflicted on subjects by using
phosphorous from bombs then treated
with various drug preparations
 Tribunal condemned experiments and
established Nuremberg Code
1/4/2018 66

Unethical…
In December 1946, 23 physicians and
administrators, were indicated before the
War Crimes Tribunal at Nuremberg for
their willing participation in the systematic
torture, mutilation, and killing of
prisoners in experiments.
Despite arguments by the physicians that
the experiments were medically justified,
the Nuremberg Military Tribunals
condemned the experiments as "crimes
against humanity";
1/4/2018 67

“Permissible medical experiment”
Nuremberg Code
1/4/2018 68

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."
1/4/2018 69

Nuremberg code…
 All unnecessary physical and mental
suffering and injury should be avoided;
 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.
1/4/2018 70

Nuremberg code…
 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.
1/4/2018 71

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.
1/4/2018 72

Declaration of Helsinki…
 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?
1/4/2018 73

 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.
1/4/2018 74

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.
1/4/2018 75

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)
1/4/2018 76

 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).
1/4/2018 77

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.
1/4/2018 78

CIOMS Guidelines …
 CIOMS promulgated guidelines in 1993
entitled International Ethical
Guidelines for Biomedical Research
Involving Human Subjects.
1/4/2018 79

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.
1/4/2018 80

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.1/4/2018 81

Research in medical
practice…
 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.
1/4/2018 82

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:
1/4/2018 83

Research in medical
practice…
Phase one research,
 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.
1/4/2018 84

Research on medical
practice…
Phase two research,
 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.
1/4/2018 85

Research in medical
practice…
Phase three research,
 is the clinical trial, in which the drug is
administered to a large number of
patients and compared to another
drug.
1/4/2018 86

Research in medical
practice…
Phase four research,
 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.
1/4/2018 87

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.
1/4/2018 88

Ethically accepted research…
 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;
1/4/2018 89

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
1/4/2018 90

II. Beneficence
Two criteria are commonly accepted as
ensuring beneficence in research.
 firstly, the study should be scientifically
valid because poor methodology may
expos subjects unnecessarily to risk.
Considerations related to the well being
of the human subject should take
precedence over the interest of science
and society. 1/4/2018 91

 III .Non-maleficence
Subject welfare must be maximized by
minimizing the degree of foreseeable
harm.
Non-maleficence is a core value of non
therapeutic research.
Subjects should ideally be exposed to
less than minimal risk.
1/4/2018 92

 IV. Confidentiality
Research necessarily involves the
collection and retention of sensitive
information about research subjects and
Every effort should be made to maintain
the confidentiality of these records.
1/4/2018 93

Assignment
 Why retrospective studies are more
problematic than prospective studies
in confidentiality?
1/4/2018 94

Under what circumstances may
a physician share patient
information?
 At the patient’s request
 To other health care workers involved in
the patient’s care
 When there is a legal duty to do so
 To maximize benefit to the patient
 To protect others
1/4/2018 95

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)
1/4/2018 96

International guidelines…
 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)
1/4/2018 97

Special circumstances
 Genetic information
 Psychological well-being
 Sexual attitudes, preferences, practices
 Substance abuse or illegal behavior
 Other information which may stigmatize or
alienate subjects may be culture specific.
1/4/2018 98

Dealing with & Protecting
Confidentiality / Privacy
 Disclosure during informed consent
 Applicable law
 Anonymization
 Means of ensuring data security
 Limiting data access
 Investigator integrity!
1/4/2018 99

Anonymization
 Not identifiable – not a problem!
 De-identify subjects by systematically
deleting identifiable information.
e.g. address, e-mail, ID card number…
 Statistical methods of de-identification
 Study ID’s are permissible if derived
independently of other identifying data &
key is locked away.
1/4/2018 100

Means of Ensuring Security
 Original records remain in Health Care
Facility (i.e. institution where research is
conducted).
 Record forms are anonymized; identifying
data or code under lock and key.
 Electronic versions are kept secure with a
password.
1/4/2018 101

Limited Data Access
 Only investigators, sponsors… have direct
access.
1/4/2018 102

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.
1/4/2018 103

Negligence
 There are four elements to negligence.
They include:
 duty,
breach,
injury, and
damages.
1/4/2018 104

Negligence…
 Duty
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.
1/4/2018 105

Negligence…
 So once a HPs/patient relationship has
been established, the HPs now owes
the patient a certain duty of care.
1/4/2018 106

Negligence…
 Breach of duty
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.
1/4/2018 107

Negligence…
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.
1/4/2018 108

Negligence…
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.
1/4/2018 109

Negligence…
 Injury
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.
1/4/2018 110

Negligence…
 Damages
The victim must suffer damages,
economic or non-economic, as a result
of the injury.
three different types of damages.
1/4/2018 111

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.
1/4/2018 112

Negligence…
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.
1/4/2018 113

Informed Consent
 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
1/4/2018 116

Consent…
 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.
1/4/2018 117

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.
1/4/2018 118

3 Components
 Information
◦ Specific items for disclosure
 Understanding
◦ Adapt the presentation to the subject’s
needs
 Voluntary agreement
◦ No threat of harm (coercion) AND no
improper reward (undue influence)
1/4/2018 119

Informed consent
Protection from harm
would protect patient from an “unwise
choice”
Protection of autonomy
demands:
full disclosure
comprehension
voluntary
competence to consent
1/4/2018 120

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
1/4/2018 121

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.
1/4/2018 122

Voluntariness
 Disclosure of alternate choices.
 Influential vs.controlling inducements
(influenced by circumstances)
Coercion : - threat
Indoctrination :- repeated instruction
manipulation
seduction
rational persuasion : - reasoning
1/4/2018 123

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.
1/4/2018 124

Incompetents…
 Mental status
Mental illness may impair a patients
capacity to provide valid consent or refusal
for an anesthetic intervention.
• Jehovah witnesses
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.
1/4/2018 125

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.
1/4/2018 126

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.
1/4/2018 127

Assent
 Children <7: No Assent
 Children 7-12: Separate Assent Form
 Teens 13-17 and Incompetent Adults:
1/4/2018 128

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
1/4/2018 129

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
1/4/2018 130

Urgent Consent-short form
◦ Administration of a synthetic blood
substitute in cases of urban trauma where
blood replacement is urgently needed.
◦ Emergent consent form initially then re-
consent later with complete form.
1/4/2018 131

Oral Consent
 Oral presentation in conjunction with a
modified consent document.
 May be preferred method depending on
the cultural context.
1/4/2018 132

Legally Authorized
Representatives
 To represent the incompetent person’s
values
 They do so at the time of initial consent
and during the study
 States define who is qualified to be a
legally authorized representative.
1/4/2018 133

Staged Consent
 When deception is necessary because
of the study design, consent may;
◦ Before: the research procedures
◦ After: Data collection to use of research
data.
1/4/2018 134

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.1/4/2018 135

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
1/4/2018 136

Special Populations
 Fetuses, pregnant women and human in
vitro fertilization
 Prisoners
 Children
1/4/2018 137

ASSINGMENT (20%)
 Discuss about the informed consent of
special populations like fetuses,
pregnant women, human in vitro
fertilization, prisoners and children.
1/4/2018 138

Uncomprehending Subjects
 Persons unable to understand and
cooperate may defeat purpose of the
research or harm themselves.
 Includes
◦ Mentally retarded
◦ Uneducated
◦ Senile
◦ Linguistically disadvantaged
◦ Inebriated / intoxicated
◦ Unconscious
◦ Dying
1/4/2018 139

Sick Subjects
 Illness is indicative of the disturbance of
the capacity to perform roles and tasks
effectively.
 Types
◦ Persons with prolonged chronic illness –
more prone to take risks to gain relief,
even if remote
◦ Depressed persons
◦ Suffering persons
◦ Emergency cases
◦ Hospitalized patients
◦ Dying
1/4/2018 140

Dependent Subjects
 Dependence by virtue of relationship with
investigator.
 Types of dependence
◦ Administrative availability – patients,
students, employees, prisoners, etc.
◦ Threatened relationships – fear of
jeopardizing relationships if they refuse to
participate.
◦ Poor subjects – unable to secure money
by ordinary means.
1/4/2018 141

Minority Groups
 Determined by age, race, sex, ethnicity,
etc.
 Culturally different – indigenous peoples
 Elderly
◦ Ageism - deep and profound prejudice
against the elderly.
1/4/2018 142

Protection of Special
Populations
 Fetuses, pregnant women and human in
vitro-fertilization
◦ Appropriate studies on animals and
non pregnant individuals have been
conducted
◦ Minimal risk
◦ Investigators should have no part and
no procedures introduced to terminate
pregnancy or determine viability of
fetus
◦ No inducement (monetary, etc.) to1/4/2018 143

Populations
 Prisoners
◦ IRB not related to prison
◦ One prisoner or prison representative in
IRB
◦ No special privileges to prisoners
recruited to the study
◦ Fair selection of prisoner subjects
◦ Risks commensurate to risks of non
prisoners
◦ Information given in understandable
1/4/2018 144

Populations
 Regular hospital patients should not be
deprived of standards of care.
 Determination of appropriate subject
population related to risks in study
intervention.
 Use of less risky subjects if possible
 Vulnerability issues should take higher
precedence than investigator
convenience
 Risk of washout periods should
assessed. 1/4/2018 145

Mitigating Procedures for
Subjects
 Exclusion of vulnerable subjects.
 Increased capacity of vulnerable
subjects to give free consent.
 Improvement of quality of consent
process.
 Creative and innovative ways of giving
information and improving
comprehension.
 Institutional policies regarding
recruitment of patients, students, etc.
 Careful calculation of fees paid to
participants. 1/4/2018 146

Mitigating Procedures for
Subjects
 Adherence to confidentiality rules
 Setting up physical structures to ensure
protection of privacy
 Debriefing procedures after data
gathering
 Counseling subjects at risks
 Avoiding circumstances that will expose
subjects to social risks or stigmatization
during the research process
1/4/2018 147

Anesthetic record
1/4/2018 148

Anesthetic record…
 Accurate record keeping should be
considered as a core skill for all
anesthetic trainees.
 A comprehensively written chart should;
Enable effective communication
Permit care to be transferred safely
Ensure postoperative orders and
prescriptions are given.
• The anesthetic chart are used as a legal
record of intra operative record of
events. 1/4/2018 149

History of anesthetic charts
 In 1894 W.Cushing and A.Codman
developed simple anesthetic chart.
 Their intention was to improve the often
basic care given to patients whilst under
ether anesthesia.
 Used to measure temperature ,pulse,
and respiration.
 Dr.Cushing insisted that these charts
ensured a greater degree of
concentration. 1/4/2018 150

What should be recorded?
Preoperative data :Assessment;
 The assessment of the patient with
basic vital signs is documented.
 Intraoperative records from previous
hospital admissions may indicate prior
problems with anesthesia;
 Medical history of problems
 Potential airway concerns
 Evaluation of teeth
• Detailed history and P/E must be recorded.
1/4/2018 155

Perioperative data: Standard data
sets;
 Data to recorded during an operation;
 Confirmation that standard checks have been
carried out on patient ,equipment and operation
 Personal involved (anesthetists, surgeons and
anesthetic assistants)
 Type of operation
 Patient positioning
 Airway
 venous and/or arterial access
 Induction
 Regional and/or local anesthesia techniques
1/4/2018 156

Perioperative data: Vital signs
 Time based charting of physiological
variables allows trends in these vital signs
to be seen.
 Pre-induction values should be recorded
for comparison.
 Pulse,BP,ETCO2 and oxygen saturation
are core vital signs that should be recorded
every 5-10 minutes.
 Blood loss may need to be recorded if
excessive or out of proportion to the
surgery. 1/4/2018 157

Perioperative data: Untoward
events
 All untoward events must be recorded in
detail on the anesthetic chart.
 These untoward events serve as:
A warning to future anesthetists and
 As a legal record of exactly what
happened during the procedure.
1/4/2018 159

Communication and
Handover
 An accurately compiled anesthetic chart
enables a colleague to take over a
patient’s care safely and securely.
 The chart should contain sufficient detail
of the patients pre-operative condition
and accurately reflect the perioperative
course through careful charting of
physiological parameters.
 It also used when handing the patient
over to recovery staff and on to ward
staff.
1/4/2018 160

Legal aspects
 Anesthetic charts are a legal record of
events that may be used as evidence
during legal proceedings at some point in
the future.
 Obstetric anesthesia is the subspecialty
most associated with legal proceedings.
 A potentially catastrophic cause of severe
morbidity is foetal hypoxia in the perinatal
period. Cases may only come to court
many years in the future when the
anesthetic chart may be the sole record of
events.
1/4/2018 161

Legal aspects…
 Medical staff present at the time may no
longer be contactable. Personal
recollection may therefore be unreliable
and the anesthetic chart may represent
the standard of care given to the patient.
1/4/2018 162

Quality of care
 It may be deemed to reflect the quality of
care given to a patient.
 A poorly written and illegible chart may
be seen to be an indicator of a poor
standard of care.
 These charts may also be used in fitness
to practice proceedings.
 During legal procedures the anesthetic
charts may be intimately examined by
lawyers, expert witnesses and lay
people.
1/4/2018 163

Quality of care…
Therefore the chart must be…
1/4/2018 164

Quality of care…
 Illegible handwriting has long been seen
as a contributing factor in the root cause
analysis of adverse incidents.
 If the chart is not easily readable then
this increases the risk of subsequent
problems. If the chart is illegible then,
fundamentally, it cannot be used as a
defense in a court of law.
1/4/2018 165

Quality of care…
 In addition, if medical records are not
signed and/or dated then the validity of
what is written may be called into
question.
1/4/2018 166

Key points
 Anesthetic charts are regarded as a legal record
of events and they should be filled out
comprehensively and legibly.
 An anesthetic record should contain sufficient
detail to enable a colleague to take over a case
with a full understanding of the patient.
 An inadequately written record may put patients
at risk, it will be no defense in the event of legal
proceedings and may be considered a reflection
of a poor standard of care.
 A carefully written chart may be utilized as both
an audit and a research tool.
1/4/2018 167

Hazards in Anesthesia
1/4/2018 168

Hazards…
 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.
1/4/2018 169

Hazards…
 Physical hazards
 Infectious hazards
 Psychological stress
1/4/2018 170

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 and1/4/2018 171

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.
1/4/2018 172

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.
1/4/2018 173

Cellular studies…
 Many studies have been performed in
animals to asses the carcinogenicity of
anesthetics.
 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.
1/4/2018 174

Cellular studies…
 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.
1/4/2018 175

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 311/4/2018 176

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
1/4/2018 177

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 American
Society of Anesthesiologist(ASA).
 Questionnaires were sent to 49,585
operating room personnel with potential
exposure to waste anesthetic gases
whereas,
1/4/2018 178

Reproductive outcome…
 23,911 from the American academic of
pediatrics and the American nurse
association served as a control group.
 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.
1/4/2018 179

 But a Swedish study clearly
demonstrates the inaccuracy
encountered when using mailed
questionnaires.
 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
1/4/2018 180

 When verified data were analyzed, there
was no statistically significant difference
between reproductive outcome in the
exposed and non-exposed.
1/4/2018 181

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.
1/4/2018 182

Infectious hazard…
 These includes;
 Respiratory viruses
 Viral hepatitis
 HIV/AIDS
1/4/2018 183

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
1/4/2018 184

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.
1/4/2018 185

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.
1/4/2018 186

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.
1/4/2018 187

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
1/4/2018 188

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.
1/4/2018 189

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
 Exposure to larger volumes of blood, especially if
the patients viral load is high
1/4/2018 190

HIV/AIDS…
 Because many patients may carry the
AIDS virus and not officially carry the
diagnosis, anesthetists should consider
all patients to potentially have the
disease.
1/4/2018 191

Recommendations of center of disease
control(CDC) for preventing transmission of
HIV
 All needles and sharp instruments should be handled
to prevent accidental injuries, and all should be
considered as potentially infected.
 Gloves are worn when touching mucous membrane
or skin of all patients.
 Wear eye protectors (goggles)during procedure such
as endoscopy and when splashes of blood or
secretions are likely to occur.
 Hand washing before and after every procedure.
 Ventilation equipment should be available to prevent
mouth to mouth resuscitation.
 Disinfect and sterilize used equipments routenly.
1/4/2018 192

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.
1/4/2018 193

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
1/4/2018 194

Other occupational hazards
 Drug abuse and addiction
 Suicide
 Radiation
 Allergic reaction, etc..
1/4/2018 195

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.
1/4/2018 196

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
1/4/2018 197

Professional ethics and Anesthesia hazards

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