You are on page 1of 52

BIOETHICS FOR

PHYSICIANS

Ngatidjan

Department of Pharmacology and Therapeutics


Medical and Health Research Ethics Committee (MHREC)
Faculty of Medicine, Universitas Gadjah Mada
Ngatidjan BIOETHICS4PHYS-2015 1
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
Ngatidjan BIOETHICS4PHYS-2015 2
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,
Ngatidjan BIOETHICS4PHYS-2015 3
MEDICAL ETHICS

To practice medicine in a manner


consistent with basic moral value,

The guidelines for proper and principled


conduct by physician.

Ngatidjan BIOETHICS4PHYS-2015 4
PHYSICIAN AND ETHICS

Patient care,

Clinical research,

Teaching and learning,

Bureaucracy,
Ngatidjan BIOETHICS4PHYS-2015 5
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.
Ngatidjan BIOETHICS4PHYS-2015 6
MEDICAL RESEARCHES
May involves :
Animals (healthy or artificially sick),
Human (healthy or illness),
Isolated cells, tissues, organs or other body
components, (from animals or human),
Groups of people or community.
Ngatidjan BIOETHICS4PHYS-2015 7
REFFERENCES
Nuremberg code 1947
Declaration of Human Right 1948
Declaration of Helsinki 1964
Undang undang / peraturan pemerintah
UU No. 23 / 1992 tentang penelitian kesehatan
Permenkes No.749/2002 tentang rekam medis
KepMenKes No.1333/2002 tentang informed consent
Etc.
Ngatidjan BIOETHICS4PHYS-2015 8
UNETHICAL RESEARCHES STORIES
1. Tuskegee Syphilis study (1930 1972),
2. Nazi doctors experimentations (WW II 1946),
3. Willowbrook hepatitis study (1950)
4. HeLa cervix cancer cell culture by George Gey (1951)
5. The Wichita jury study (1955)
6. Milgram study (1960)
7. Thalidomide accidents (1955 1961)
8. San Antonio contraceptive study (1970)
9. Etc.
Ngatidjan BIOETHICS4PHYS-2015 9
Tuskegee scandal (1932 1972)
o A study conducted by Tuskegee Institute (Alabama) :
82% of residence were black and poor, 36% of them were
suffering from syphilis)
a research the study of untreated syphilis in negro male
399 patients did not receive any medical treatment at all
(although in 1942 the penicillin was available)
the study was to know the course of the disease.
they were not informed about their disease and risks,
they got free medical exam, free meal and burial insurance,
the scandal was discovered by a journalist, Jean Heller.
the study was then stopped by the authority without trial.

with other researches Belmont report


Ngatidjan BIOETHICS4PHYS-2015 10
The Nuremberg Military Tribunal (1946)
20 Nazi doctors Joseph Mengele, Eduard Wirths, Karl
Brandt, Viktor Brack, Rudolf Brandt, Karl Gebhardt,
Waldemar Hoven and others, conducted some
medical experiments on captive soldiers :
o sterilizations,
o experiment on twins,
o tests of potential chemical weapons,
o deliberate infections,
o human response to extreme physical conditions (0o C),
o bizarre transplantation experiments.
o etc., under inhumanity condition

Nuremberg code
Ngatidjan BIOETHICS4PHYS-2015 11
The Nuremberg
Military Tribunal (1946)

Many defendants argued


that the experiments
were morally justified

o Participants were
going to die anyway,

o Sacrifice would
provide scientific
knowledge and many
benefiting results.

o 15 of the 25 defendants (20 MDs) were found guilty and

o 7 were sentenced to death


Ngatidjan BIOETHICS4PHYS-2015 12
NUREMBERG CODE 1947
Voluntary involvement,
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.
Ngatidjan BIOETHICS4PHYS-2015 13
Willowbrook hepatitis study (1950)
800 children Willowbrook (State School for Mentally
Retarded)
New admitted mentally disable were inoculated with
infectious hepatitis virus
o early subjects were fed with food containing the
extracts of stools from infected individuals,
o later, subjects received injections of more purified
virus preparations,
objective of the study was to determine the period of
infection
No any information (informed consent) for the parent

Ngatidjan BIOETHICS4PHYS-2015 14
HeLa (Henrietta Lacks) CELLS
HeLa cervix cancer cell was cultured
the biopsy without any informed consent.
even when the same doctor did on her doughter.
HeLa cell cultivation
some company got a lot of benefit from the cell,
patient (Henrietta Lacks) and he families got
nothing.
ethical problems
Ngatidjan BIOETHICS4PHYS-2015 15
HeLa (Henrietta Lack) cells
1951 George Gey successfully cultured the first immortal human cell line
without informed consent
from Henriettas cervix cancer cells
it is given the name HeLa (Henrietta Lacks),

1951 Henrietta Lacks dies of an unusually aggressive cervical cancer

1952 HeLa cells become the first living cells shipped via postal mail.

1952 The Tuskegee Institute opens the first HeLa factory, supplying
cells to laboratories and researchers and operating as a nonprofit.
Within a few years, a company named Microbiological Associates
began to sell HeLa cell line for profit .
Ngatidjan BIOETHICS4PHYS-2015 16
Thalidomide
Developed in Germany 1953
preclinical study?

Introduced in Germany in 1956


as mild sedative was claimed also safe for pregnancy

1956 1961 reported caused malformation


phocomelia even amelia
7.000 10.000 malformation babies by 1961

1962 was banded.


Ngatidjan BIOETHICS4PHYS-2015 17
St Antonio Contraceptive study (1970)
o Women as the researh subject :
one group received contarceptive,
other group received placebo,
o They were told to have normal sexual
activity
o But they were not received informations of
the risk of unexpected pregnancy if the drug
they received was placebo,
o Some got unexpected pregnant stress.
Ngatidjan BIOETHICS4PHYS-2015 18
OTHER CLINICAL PRACTICES, ETHICS?
1. Kidney donation (1954)
the risk of donor to have major surgery, loss of an organ,
2. Heart transplantation Dr. Christian Barnard (SA), (1967)
arteficial (heart) pump to maintain blood circulation,
was the heart donor really dead? How to define deadth,
3. Karen Ann Quinlans irreversible coma (1976)
she had had life support machines to maintain
cardiopulmonary function,
the machine maintained the function for years. Is she
really life or die?
she has right to die by stoping the machine who will
do? Her parents have right to do? She dies 1985.
Ngatidjan BIOETHICS4PHYS-2015 19
RESEARCH ON IVF ETHICAL ISSUE
5. Bunge and Sherman (1953)
the first successful AI with frozen sperm in human,
6. Chang (1959)
the first rabbit to be born as a result of in vitro
fertilization (IVF),
7. Carl Wood and John Leeton (1976).
first human pregnancy by IVF,
8. Louis Brown was born (1978)
the first successful human IVF in UK,
9. Alastair MacDonald was born (1979)
the second baby of human IVF in UK,
Ngatidjan BIOETHICS4PHYS-2015 20
Belmont Report (1979)
o
o
Irreversible coma, Artefisial life support (1976) o
o
St Antonio contraceptive study (1970)
o
First IVF baby
Heart transplantation (1967) o born (1978)

o
o
Milgram study (1963) o
Declaration of Helsinki (1964)
o
Kidney donation (1954)
o Thalidomide accident (1955 -1961)

Willowbrook study (1950) o


o HeLa cell (1951 1952)
Nuremberg Trials o
o
(1946) Nuremberg Code (1947)
o

o Nazi doctor experimentation (1940 - 1945)

o Tuskegee scandal (1932 1972)


Ngatidjan BIOETHICS4PHYS-2015 21
DECLARATION OF HELSINKI
1. Ethical principles in designing and conducting
research on human subjects.
2. The declaration is addressed to physician and
other participan in research on human.
physician responsible for safe guarding of subject health.

3. Ethics principles in research on :


Healthy subject,
Sick or ilness subjects patients,
Vulnerable subjects,
Tissues or samples obtaining from human,
Data of human subjects.
Ngatidjan BIOETHICS4PHYS-2015 22
DECLARATION OF HELSINKI

4. Researcher must scientifically competence and


trined in skill,
5. Protocol and research design must be :
Written clearly and detail,
The aims of the study,
Scientific based (back ground and relevant studies),
Subject criteria (inclusive, exclusive, withdrawn etc.),
Sample size (scientifically based),
Research procedure,
The length of the study,
Informed consent,
Ngatidjan BIOETHICS4PHYS-2015 23
DECLARATION OF HELSINKI

Other points :
Sponsor statements about the financial
support,
Afiliated institutions,
Other aspects may cause conficts, such as
incentive, provoso, compensation for subjects
if undesired events
Therapeutical acses after completeion of the
study etc.).
Ngatidjan BIOETHICS4PHYS-2015 24
DECLARATION OF HELSINKI
6. Researcher has to protect the life :
Human dignity and integrity,
Right to sel determination,
Justice,
Privacy and confidentiality,
Beneficence,
Do no harm.

Shown in the protocol


Ngatidjan BIOETHICS4PHYS-2015 25
TO BE ETHICS IN RESEARCH ON HUMAN

FOLLOW GOOD CLINICAL PRACTICE (GCP)

Ngatidjan BIOETHICS4PHYS-2015 26
GOOD CLINICAL PRACTICE (GCP)

is an international ethical and


scientific quality standard for
designing, conducting, recording
and reporting research that involve
the participation of human subjects.
Ngatidjan BIOETHICS4PHYS-2015 27
GOOD CLINICAL PRACTICE
1. Good written protocol,
2. Qualified investigator,
3. Good research facilities,
4. Sufficient budget (sponsor),
5. Good monitor,
6. Qualified reviewer (IRB),
7. Good regulator (Goverments).
Ngatidjan BIOETHICS4PHYS-2015 28
Good Written Protocol
Clear and detail explanation,
Scientific background and the aims of the study (including
the relevan researches & findings),
Subject criteria (inclusion, exclusion, withdrawn),
Sample size (scientific calculation),
Research procedure,
Site and the length of the research,
Informed consent,
Other aspects : statement of funding, sponsor, afiliated
institution, conflict of interest, insentive provision
compensation for research subject in case of AE or SAE,
and therapy acces after the completition of the research).
Ngatidjan BIOETHICS4PHYS-2015 29
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,
Ngatidjan BIOETHICS4PHYS-2015 30
ETHICS IN PATIENT CARE

Ngatidjan BIOETHICS4PHYS-2015 31
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,
Ngatidjan BIOETHICS4PHYS-2015 32
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,
Ngatidjan BIOETHICS4PHYS-2015 33
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?


Ngatidjan BIOETHICS4PHYS-2015 34
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,

Ngatidjan BIOETHICS4PHYS-2015 35
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.
Ngatidjan BIOETHICS4PHYS-2015 36
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.
Ngatidjan BIOETHICS4PHYS-2015 37
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.
Ngatidjan BIOETHICS4PHYS-2015 38
EUTHANASIA

An act or omission intended to cause


death in order to elinimate suffering,

A person may euthanize themselves or


another person euthanize them,
Ngatidjan BIOETHICS4PHYS-2015 39
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.
Ngatidjan BIOETHICS4PHYS-2015 40
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 wich might otherwise sustain life.
physician assisted suicide,
voluntary euthanasia which involves doctor to prepare the apparatus
Ngatidjan BIOETHICS4PHYS-2015 41
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.
Ngatidjan BIOETHICS4PHYS-2015 42
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.
Ngatidjan BIOETHICS4PHYS-2015 43
BIOETHICAL APPROACH
to make decission for a clinical situation

1. Priciplism,

2. Consequentialism,

3. Casuistry.
Ngatidjan BIOETHICS4PHYS-2015 44
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
Ngatidjan BIOETHICS4PHYS-2015 45
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.
Ngatidjan BIOETHICS4PHYS-2015 46
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.).
Ngatidjan BIOETHICS4PHYS-2015 47
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.
Ngatidjan BIOETHICS4PHYS-2015 48
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.
Ngatidjan BIOETHICS4PHYS-2015 49
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.
Ngatidjan BIOETHICS4PHYS-2015 50
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?
Ngatidjan BIOETHICS4PHYS-2015 51
ngatidjansp@gmail.com

Matur Nuwun
Ngatidjan BIOETHICS4PHYS-2015 52