Bioethics and
Research
Medical Ethics
Clinical Ethics
BIOETHICS the study of
ethical, social, and legal
Nursing Ethics
issues that arise in Research Ethics
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biomedicine and
biomedical research. Environmental Ethics
Public Health Ethics
A. PRINCIPLES OF ETHICS
IN RESEARCH
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A. Principles of Ethics in
Research
1. NUREMBERG CODE 2. DECLARATION OF 3. BELMONT REPORT
HELSINKI
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1.NUREMBERG CODE
1. NUREMBERG CODE
Result of the horrific and unethical
experiments carried out during the World
War II at Nazi war camps by German
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physicians.
The Nuremberg Code
1. The voluntary consent of the
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human subject is absolutely
essential.
2. The experiment should be
such as to yield fruitful results
for the good of society,
unprocurable by other
methods or means of study,
and not random and
unnecessary by nature. 7
3. The experiment should be so
designed and based on the results of
animal experimentation and a
knowledge of the natural history of the
disease or other problem under study
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that the anticipated results justify the
performance of the experiment.
4. The experiment should be so
conducted as to avoid all
unnecessary physical and
mental suffering and injury.
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5. No experiment should be
conducted where there is a prior
reason to believe that death or
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disabling injury will occur; except,
perhaps, in those experiments where
the experimental physicians also serve
as subjects.
6. The degree of risk to be taken
should never exceed that
determined by the
humanitarian importance of the
problem to be solved by the
experiment.
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7. Proper preparations should be
made and adequate facilities
provided to protect the 12
experimental subject against even
remote possibilities of injury,
disability, or death.
8. The experiment should be
conducted only by scientifically
qualified persons. The highest degree
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of skill and care should be required
through all stages of the experiment
of those who conduct or engage in the
experiment.
9. During the experiment, the human
subject should be at liberty to bring
the experiment to an end if he/she
has reached the physical or mental
state where continuation of the
experiment seems to him/her to be
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impossible.
10. During the experiment the scientist in charge
must be prepared to terminate the experiment
at any stage, if he/she has probable cause to
believe, in the exercise of the good faith,
superior skill, and careful judgment required of
him/her, that a continuation of the experiment is
likely to result in injury, disability, or death to the
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experimental subject.
Set of ethical Principles
for the medical
II. THE Developed by the World
Medical Association
community regarding
human experimentation.
DECLARATION
OF HELSINKI
Developed from 10 principles of
Nuremberg Code 1947 and
incorporated elements from the
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Declaration of Geneva (made in
Initially adopted in 1948), a statement of the ethical
duties of physicians.
June 1964 in Helsinki,
Finland.
Research protocols should be
Research with humans reviewed by an independent
should be based on the committee before initiation.
results from laboratory and
animal experimentation
Informed consent
from research
participants is
Research should be conducted by 17
necessary.
medically/scientifically qualified
individuals.
Risks should not exceed the
benefits.
III.
“Ethical Principles And
BELMONT April 18, 1979 – former Guidelines For The
U.S Department of Protection Of Human
REPORT Health,, and Welfare Subjects Of Research”
(renEducationamed as
Health and Human
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Services)
Respect For Persons
- Informed Consent THREE
FUNDAMENTAL
Beneficence
- Assessment of Risks and Benefits PRINCIPLES OF
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RESEARCH ETHICS
Justice
- Selection of Subjects
B. ETHICAL ISSUES IN EVIDENCE-
BASED
PRACTICE
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ETHICAL ISSUES
occur when a given decision,
scenario or activity creates a
conflict with a society’s
moral principles. EVIDENCE
something that furnishes proof
or testimony or something
legally submitted to ascertain
in the truth of matter.
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EVIDENCE BASED PRACTICE is
the use of the current best
evidence in making decisions
about the patients.
Some types of knowledge are
not included in the
evidence-based practice
ISSUES/CONCERNS ABOUT
EVIDENCE-BASED
PRACTICE
Evidence-based practice runs
counter to patient-centered care.
"Testable by Randomized
Controlled Trials" is not the
same as "most effective".
ISSUES/CONCERNS ABOUT
EVIDENCE-BASED
PRACTICE
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Decisions based on EBP
can be unjust.
C. ETHICO-MORAL OBLIGATIONS OF
THE NURSE IN EVIDENCE-BASED
PRACTICE
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Good Clinical
Practice Guidelines
Good Clinical
Practice Guidelines
"an international, ethical, and
scientific quality standard for the
serves to protect rights,
design, conduct, performance, 25
integrity, and confidentiality of
monitoring, recording, analysis,
trial subjects.
and reporting of clinical trials."
Ethico-Moral Aspects Of
Nursing Practice
Develop sensitivity to Examine their own Understand how Think ahead about
the ethical and client’s value values influence their the moral problems
dimensions of decisions they are likely to face
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nursing practice
Moral/Ethical Dilemma ETHICAL ISSUES
Two or more clear principles apply but they support inconsistent
courses of action
Moral Distress
Moral Uncertainty/Conflict When the nurse knows the right thing to do but organizational
When the nurse is unsure which moral principle to apply, or even
constraints keep them from doing it
what the problem is. Common with new nurses.
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Moral Outrage
An individual witnesses an immoral act by another but feels powerless
to stop it.
460B
C Oa
th of
1930 Hipp
's U. ocrat
S. Fo es
Historical background 1947
Dec.
10th
Nure
mber
od, Dr
g
u
Code
g s and
Cosm
etic A
ct
1948
of Good Clinical Practice 1962
1964
Kefau
, revi
sed 2
ver-H
Decla
ratio
arris
Amen
n of H
uman
Right
000 dmen s
1979 t
The B Decla
1982 elmo ratio
nt Re n of H
Inter port elsink
Rese n ation i
arch a l Guid
Invol eline
1996 ving s for
Hum Biom
ICH-G an Su edica
1997 C P gui bjects l
ICH-G d e lines
CP gu issue
coun idelin d
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tries es be
come
s law
in so
me
13 Principles of
Good Clinical
Practice Guidelines
1. Clinical trials should be conducted in
accordance with ethical principles that
have their origin in the Declaration of
Helsinki, and that are consistent with 2. Before a trial is initiated, foreseeable
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GCP and the applicable regulatory risks and inconveniences should be
requirement(s). weighed against anticipated benefit for
the individual trial subject and society. A
trial should be initiated and continued
only if the anticipated benefits justify
the risks.
3. The rights, safety and well-being of
the trial subjects are the most
important considerations and should
prevail over interest of science and
society.
4. The available non-clinical and clinical
information on an investigational
product should be adequate to support
the proposed clinical trial.
5. Clinical trials should be
scientifically sound, and
described in clear, detailed
protocol.
6. A trial should be conducted in compliance
with the protocol that has received prior
institutional review board (IRB)/
independent ethics committee (IEC)
approval/favourable opinion.
7. The medical care given to, and medical
decisions made on behalf of subjects
should always be the responsibility of a
qualified physician or, when appropriate,
of a qualified dentist.
l v ed in
l i n vo d be
v i d u a sh o u l ,
h i ndi a trial cation to
ac g du ce
8. E ductin d by e erien
con ualifie nd exp or her
q
i n g, a m his sk(s).
n r
trai perfo tive ta
pec
res
9. Freely given informed consent
should be obtained from every
subject prior to clinical trial
participation.
10. All clinical trial
information should be
recorded, handled, and
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stored in a way that allows
its accurate reporting,
interpretation and
verification.
l
2 . I n v es t i g a t i on a
11. The confidentiality of 1
o d u c t s s h ou l d b e
records that could pr
c t u r e d , handled
m an u f a
identify subjects should
re d i n a c cordance
be protected, respecting a n d st o
a p p l i c a b l e G ood 13.
the privacy and wit h
t u ri n g P ractice S ys
tem
M a n u fa c a ss sw
confidentiality rules in u ld b e ure
h e y s h o a sp the it h
( G M P) . T ect q u al
pro
accordance with the
rd a n ce w i t h of t it y ced
used in a
34 c c o im p
lem he of e ures t
applicable regulatory p r o t oc ol . ent t rial ver h at
v e d sh o y
requirement(s). the appro ed. u ld
be
Guidelines and Protocol in Documentation
and Health Care Records
Nursing documentation is aligned
with the 'Nursing Process' and it
reflects the principles of
assessment, planning,
implementation, and evaluation. It
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is continuous and the nursing
documentation should reflect this.
1. Each page in the record contains the
patient's name or patient number.
2. Personal biographical data includes the
address, employer, home and work numbers,
and marital status.
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3. All entries in the medical record contain
the author's identification.
4. All entries are dated.
6. Significant illnesses
5. Legible to everyone. and medical conditions
are indicated.
7. The history and physical examination 37
identifies appropriate subjective and
objective information pertinent to the
8. Laboratory and other
patient's presenting complaints.
studies are ordered, as
appropriate.
Thank you!
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