PHYSICIANS AND ETHICS

Ngatidjan

Department of Pharmacology and Therapeutics

Medical and Health Research Ethics Committee (MHREC)
Faculty of Medicine, Universitas Gadjah Mada
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PHYSICIAN AND ETHICS

Patient care,

Clinical research,

Teaching and learning,

Bureaucracy,
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ETHICS

Basic moral value.

Principles and guidelines for proper and
principled conduct by human,
The science of moral,
study of the principles of human life,
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MEDICAL ETHICS

To practice medicine in a manner

consistent with basic moral value,

The guidelines for proper and principled

conduct by physician.

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BIOETHICS
Bios-life and ethos-behavior
the science of human behavior in biological
research involving plant, animal and human,
The study of controversial ethics brought about
by advances in biology and medicine,
Ecological bioethics, medical bioethics and
clinical bioethics
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ISSUES IN MEDICAL BIOETHICS
Clinical research :
Clinical researches for drugs, methods of non-drug
treatments (in radiology, surgery, psyachiaty etc.),
Arteficial life for blood harvesting,
Human cloning,
Gene therapy,
Gene modification,
Human genetic enginering,
Iatrogenesis,
Sex reassignment therapy,

Patient care
Life support, body modification (certain plastic surgery), assisted
suicide euthanasia, etc.
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MEDICAL RESEARCHES
May involves :
Animals (healthy or artificially sick),
Human (healthy or getting sick),
Isolated cells, tissues, organs or other body
components, (from animals or human),
Groups of people or community.
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STUDY ON HUMAN
Interventional study
give treatment / intervention
food, drug, inflict certain condition

Noninterventional study
case control,
cohort, Ethical Consideration
cross sectional,
survey
(observation or interview)
explore subject right
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UNETHICS RESEARCHES STORIES
1. Tuskegee scandal (1930)
a study conducted by Tuskegee Institute (Alabama 1930 1972)
in Mason country (82% of residence were black and poor; 36% of them
were suffering from syphilis)
the patients did not receive any medical treatment at all although penicillin
was available (the study was to know the course of the disease).
the scandal was discovered by a journalist, Jean Heller.
the study was then stopped by government authority without any trial.

2. Nazi (Nuremberg) scandal (1947)

Nuremberg doctor trial on captured people as the subjects.
the study was discovered in correlation with Nuremberg military tribunal.

ethical basis Nuremberg code

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UNETHICS RESEARCHES STORIES
3. Willowbrook hepatitis study (1950)
infecting healthy children by feeding with active hepatitis patient
feces containing food,
4. The Wichita jury study (1955)
subject did not know without informed consent,
5. Milgram study (1960)
the role of negative reinforcement of on learning, upset
6. San Antonio contraceptive study (1970)
placebo involvement unexpected pregnant.
7. Etc.
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NUREMBERG CODE (1948)
Voluntary.
Must have fruitful result.
Based on the result on animal experimentation.
As to avoid unnecessary physical or mental suffering.
Not an life-death harmful result.
Degree of risk should never exceed the humanitarian.
Proper and adequate facilities.
Scientifically qualified researcher.
Subject may withdrawn freely from the study.
Experimentation may be stopped anytime if harmful
result observed.
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BELMONT REPORT (1974)
Basic principles of ethics
1. Respect to persons,
Treat individuals as autonomous agents,
Protect persons with diminished autonomy,

2. Beneficence,
Do unto others as you would have them do unto you,

3. Justice,
Distribute the risks and potential benefits of research equally
among those who may benefit from the research.
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BASIC PRINCIPLES OF ETHICS

o Respect for person,

o Justice,
o Autonomy human right informed consent,
o Confidential,
o Beneficence,
o Non malfeasance. 13
BASIC PRINCIPLES OF ETHICS
1. Respect for person
respect for person as human (humanity)
respect for autonomy self determination
respect for the right autonomy
informed consent

2. Justice
treat everyone in the same manner according to
morally right and proper, dignity and their right.
randomization is an example.
balance of the right and responsibility
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INFORMED CONSENT
a set of subject statement consists of :
the voluntariness to joint in a study
after having information's of a study, including :
the procedure of the study
the risk or any uncomfortable condition may occur
the advantage of the study
any alternative therapy can be given
person can be contacted in an emergency condition
the possibility of stop joining in the study
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INFORMED CONSENT
Informed
having information
an information process must happened
Consent ( after comprehension)
to give assent or approval
compliance in or approval of what is done
or proposed by another
agreement as to action or opinion
Volunteerness to join in the study
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INFORMED CONSENT

Voluntariness
pressure free free from the following things :
give, reward, present etc. no inducement participations
status (student from teacher, soldier from commander)
threat (refuse to joint will get bad mark, will not be serviced)
fear (fear about future live if refuse to joint into the study)

consent or willing to participate in the study

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INFORMED CONSENT

individual consent
(in developed community, urban area).

community consent
(in underdeveloped community, and may
represented by key person).

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INFORMED CONSENT

Expressed
orally
written

Implied or tacit (silent, understanding each other)

normal or constructive consent
emergency consent
(consent in an emergency situation)
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CONFIDENTIAL
Information
data, sample / materials have to be kept as a screed.
selective disclosure of information.

The use of data or sample

as the purposes stated or the aims of the study

Respondent identity
respondent's identity have to be transformed
to identity number (respondent`s number)
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CONFIDENTIAL
Client data is confident
be ware about data handling and storing.
is it unlinked or linked information?
linked information anonymous code.
written or verbal interview (recorded).

do not give any chance to anyones else to

trace certain (interesting) information
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BENEFICIAL BENEFICENCE

A research must have :

Benefits
directly to subjects controlling serum lipid level).
indirectly to subjects epidemiologic study

Less minimal risk,

benefit risk ratio analysis,
Maintain individual welfare.
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BENEFICIAL BENEFICENCE

Maximizing benefit,
inform to subject about the benefit of the study.
coordinate with relatives to maximize the benefit.
accommodate the need of subjects ( patients care).
participation of relatives (his, her, or their family).
to understand the important of the study.
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DO NO HARM (NONMALFICENCE)
Minimizing possible harm.
inclusion criteria
according to individual patient characteristic (sex, age etc.)
according to disease characteristic (severity, duration etc.)
in or out patients

exclusion criteria
according to individual patient characteristic (pregnant etc.)
according to disease characteristic (severity, duration,
complicating disease, failure to response to drug etc.)
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DO NO HARM (NONMALFICENCE)

Minimizing possible harm.

- prevent causing harm or doing wrong.
(does not do thing that is taboo).

- prevent the occuring of harm and harmful publicity.

- respect to social mores (for some reason).

- sensitive to different culture

do not encounter to existing culture.
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DO NO HARM (NONMALFICENCE)

Placebo involvement?
o is used when no any standard treatment for the disease.

o effective if the effect of test drug is much influenced by

subjective factor (pain, comfort etc.)

o is appropriate for mild to moderate condition of disease,

contraindicated for life threatening state of disease.

no placebo for study of infection therapy etc.

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ETHICAL CLEARANCE
a written statement concerning the ethical property of study
on human (or animal)
issued by an IRB (institutional review board)
in the Faculty of Medicine UGM :
Komisi Etik Penelitian Kedokteran dan Kesehatan
Fakultas Kedokteran UGM
MHREC, Medical and Health Reseach Ethic Committee,
Faculty of Medicine UGM
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 HOW TO GET ETHICAL CLEARANCE
1. Good written proposal of study on human (or animal)
Scientific aspect
Ethical aspect

2. Pesearch proposal is submitted to IRB

Review is communicated to researcher
Presentation clarify communication
Rewrite resubmit re-review communication

3. Ethical Clearance issued

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OTHER ISSUES IN BIOETHICS
Clinical research (e.g.) :
arteficial life for blood harvesting,
human cloning,
gene therapy,
gene modification,
human genetic enginering,
iatrogenesis,
placebo drugs,
sex reassignment therapy,
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(DiBerardino, 2004)
(DiBerardino, 2004)
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(David A. Prentice, Ph.D.)
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(Maimetes, 2011)

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The classical derivation of embryonic stem (ES) cells destroys the embryo from which they are derived.

Donorspecific pluripotent stem cells can be made using nuclear transfer (NT) techniques.

(Maimetes, 2011)
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(David A. Prentice, Ph.D.)
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ETHICS IN PATIENT CARE

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ISSUES IN BIOETHICS
Patient care (e.g.) :
withholding or withdrawing life support,
body modification (certain plastic surgery),
assisted suicide euthanasia,
blood transfusion for certain religious witenesses,
organ transplantion,
egg or sperm donation,
surrogate mother,
abortion,
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ISSUES IN BIOETHICS
Other issues (e.g.) :
euthanasia,
cryonic practice,
exorcism,
medical malpractice,
spiritual drug use,
stem cell research,
transexuality,
organ, egg and sperm donation,
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 LIFE SUPPORT
Withholding or withdrawing life support
is the most difficult actions for physicians,
Withdrawing life support may allowing a patient to die
life could have been prolonged with life support,
Life support for severely ill patient with irreversible condition,
the only choices available may be :
a prolonged and miserable dying or
a more rapid, comfortable and dignified death,

Which one is the choice?

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LIFE SUPPORT
If death can represent
an end from suffering and
can prevent (a life that have been happy) from ending
with prolonged misery,

a painless and dignified death is sometimes the best that

a physician has to offer, and there is no shame to do this.

withdrawing of life support is the choice,

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 LIFE SUPPORT
Withholding life support for severely ill patient with
irreversible condition,
may prolonged and miserable dying,

Physician can determine whether further treatment is

medically futile or inappropriate, based on existing objective
conditions.
If there is no chance to regain any reasonable quality of life
withdraw the life support,
if there is chance to get a regain of the life
withhold the life support.
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 LIFE SUPPORT
Futility implies that there is(are) an(some) accurate tool(s) for
identifying which patients are likely to improve or recover.
there must be scoring system to predict the outcome of
the treatment given.

Any decision (to withhold or withdraw life support) should be

a part of a coherent and comprehensive management plan.
must be related to clearly identified patient oriented goals.
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LIFE SUPPORT
Legal aspect
malpractice and criminal action of withholding or withdrawing is rare,
often, contrary between physician / hospital and the wishes of patients family,
if there is no regulation upon it, a result of a medical team may be the solution,

Patient with decision making capacity

the patients have right to refuse advanced life support, medically supplied
nutrition and hydration (legal in many state countries) euthanasia?
an essentially no chance of regaining any reasonable quality of life is important
thing to be considered.

Patient lacks for decision making capacity

patient legal guardianship may take responsible,
an essentially no chance of regaining any reasonable quality of life is important
thing to be considered.
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 EUTHANASIA

An act or omission intended to cause

death in order to elinimate suffering,

A person may euthanize themselves or

another person euthanize them,
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EUTHANASIA
Good death (eu: good, thanatos: death),
the act or practice of ending the life of an individual
suffering from a terminal illness or an incurable condition,
putting terminally ill and suffering patient to death in
painless manner.
can be done by lethal injection of an agent or the
suspension of extraordinary medical treatment.

It is not relevant to critical care, ICU and life

support.
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 EUTHANASIA
involuntary euthanasia,
termination of life against the will of person / patient,
non-voluntary euthanasia,
termination of life without the consent of person / patient,
voluntary euthanasia,
termination of life at the request of person / patient,
active euthanasia,
a positive contribution to the acceleration of death, assisted
pasive euthanasia,
omission of step which might otherwise sustain life.
physician assisted suicide,
voluntary euthanasia which involves doctor to prepare the apparatus
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VOLUNTARY EUTHANASIA
is it truly voluntary?
how is it mean if patient in unconsciousness state?

how to differentiate voluntary, in or non

voluntary?
consciousness and consent?

is it legal?
legal law precedent, abuse etc.
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PERSISTENT VEGETATIVE STATE (PVS)
an individual shows no elements of consciousness
over a significant period of time (usually a year) and
has only minimal electrical activity within the brain,
can not communicate with or perceive the external world at all
and are not even aware of their existence.

the people is still human beings but their state is

in the term of vegetable like.
hundreds of patient in the vegetable like (PVS) can have woken
up but hundreds also came to the end of life.
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BIOETHICAL APPROACH
to make decission for a clinical situation

1. Priciplism,

2. Consequentialm,

3. Casuistry.
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PRINCIPLISM
An action must be evaluated on the basis of
inherent quality of the action itself, and the
motivation or intention underlying the action,
Basic principles of ethics :
Respect to person,
Autonomy
Justice,
Beneficence,
Non-malficence
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CONSEQUENTIALISM
An action can be judged (right or wrong)
based on their consequences or end.
anticipatory, projected calculation of the
likely positive or negative result of different
identified options before decissions and
action are carried out,
patient should be the center of calculation
of consequences for the scenario. 54
CONSEQUENTIALISM
Important points to be considered
patient should be the center of a calculation,
disclosure or non-disclosure impact to the patient
negative or positive impact,
patient family positive or negative,
bedside nurse disclosure or non disclosure,
hospital organization SOP, regulation,
wider community impact (leprosy, HIV, influenza, DF and
DHF, tbc, H5N1 viral infection etc.).
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CASUISTRY
Ethical analyis of an action can be based on
practical judgement about the similarities and
differences between and among cases.

medicine and law precedent can be used.

blood transfusion for 25 years old ICU patient

with Downs syndrome, his family refuse to the
transfusion because of religious beliefs.
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PRACTICAL GUIDELINES
for ethical decision making

1. Recognize patients as partners in their health care,

2. Establish who has authority for decision making,
3. Establish effective communication with patient and
their love ones, through routinely scheduled family
meeting,
4. Determine patient values and preferences in an
ongoing manner.
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PRACTICAL GUIDELINES
Physician can make objective calculation to
determine whether further treatment (action) is
medically futile or inappropriate, based on :
existing objective conditions (coma, PVS, etc.),
if there is no chance to regain any reasonable
quality of life tell to patients family.
if there is chance to get a regain of the life
tell to patients family.
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BODY MODIFICATIONS

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Patient care
1. What is the patients medical problem? history? diagnosis?
prognosis?
2. Is the problem acute? chronic? Critical? emergent?
reversible?
3. Planning treatmen? What are the goals of treatment?
4. What are the probabilities of success?
5. What are the plans in case of therapeutic failure?
6. How can this patient be benefited by medical and care,
and how can harm be avoided?
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ngatidjansp@gmail.com

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