Human

Experimentati
on
THE MORAL ISSUE

History of Medical Research

The history of medical research

on human subjects is as old as
the history of medicine itself

Human Cadavers

Ancient Physicians believed

that the dissection of human
cadavers in order to study
human anatomy was
insufficient to gain knowledge
about the malfunctions of the
body.
Aristotle (384-322BC), the
great Greek philosopher,
known as the inventor of
formal logic and ranking as
one of the great biologist of
all time taught that one had
to study the living body in
order to understand biological
functions and malfunctions.

More Facts about

Aristotle:
He was acquainted
with more than 500
different species of
animals
Aristotle
had
dissected
and
investigated in detail
some
fifty
kinds
ranging
over
the
whole animal kingdom

Vivisection

Latin vivus living ,

alive
+
sectio
cutting
A vivisection was an
ancient
experimentation
performed on living
animals by means of
operations
In those days the
human
subjects
of
vivisections
were
condemned criminals.

Human Experimentations
- Nazi Experiments-

Sulfanilamide
To test the effectiveness of
sulfanilamide, cuts were
deliberately made on the
bodies of prisoners, then
the wound were infected
with bacteria.
The infection aggravated
by forcing wood shavings
and ground glass into the
wounds.
Then sulfanilamide and
other drugs were tested
for their effectiveness in
combatting the infection

Malaria
Healthy inmates were
injected with extracts from
the mucous glands of
mosquitoes to produce
malaria
Various drugs were then
used to determine their
relative effectives
Numerous healthy prisoners
were deliberately infected
with the spotted-fever virus
for the sole purpose of
keeping the virus alive.
Over 90 percent of those
infected subsequently died

Poison
Various kinds of
poisons were
clandestinely
administered to a
number of inmates to
test their efficacy
The inmates died or
were killed at once so
that autopsies could be
performed
Some experimental
subjects were shot with
poisoned bullets

Sealed Chambers
To help the German Air
Force. Investigations were
made into the limits of
human endurance and
existence at very high
altitudes
Prisoners were placed in
sealed chambers, then
subjected to very high and
very low atmospheric
pressures
Many victims died as a result
of these experiments and
others suffered grave injury,
torture, and ill-treatment

Post-World War II Nuremberg trials

15
German
medical
professionals who allegedly
conducted
such
human
experimentations
were
convicted
of war crimes
and
crimes
against
humanity in the now famous
post-World War II Nuremberg
trials
handled
by
the
International
Military
Tribunal 1945-1946

Nuremberg Code (1946)

The Nuremberg code is a ten-point principle s that
should be followed in conducting human
experimentations

Number one
The voluntary consent of the human
subject is absolutely essential.

 This means that the person involved should have legal capacity to
give consent; should be so situated as to be able to exercise free
power of choice, without the intervention of any element of force,
fraud, deceit, duress, over-reaching, or other ulterior form of
constraint or coercion; and should have sufficient knowledge and
comprehension of the elements of the subject matter involved, as
to enable him to make an understanding and enlightened
decision.
This latter element requires that, before the acceptance of an
affirmative decision by the experimental subject, there should be
made known to him the nature, duration, and purpose of the
experiment; the method and means by which it is to be
conducted; all inconveniences and hazards reasonably to be
expected; and the effects upon his health or person, which may
possibly come from his participation in the experiment.

Number two
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 in nature.

Number Three
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, that the
anticipated results will justify the performance
of the experiment.

Number Four
The experiment should be so
conducted as to avoid all
unnecessary physical and mental
suffering and injury.

Number Five
No experiment should be conducted,
where there is anapriorireason to believe
that death or disabling injury will occur;
except, perhaps, in those experiments
where the experimental physicians also
serve as subjects.

Number Six
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.

Number Seven
Proper preparations should be made
and adequate facilities provided to
protect the experimental subject
against even remote possibilities of
injury, disability, or death.

Number Eight
The experiment should be conducted only
by scientifically qualified persons. The
highest degree of skill and care should be
required through all stages of the
experiment of those who conduct or
engage in the experiment.

Number Nine
During the course of the experiment, the
human subject should be at liberty to
bring the experiment to an end, if he has
reached the physical or mental state,
where continuation of the experiment
seemed to him to be impossible.

Number Ten
During the course of the experiment, the
scientist in charge must be prepared to
terminate the experiment at any stage, if he
has probable cause to believe, in the exercise
of the good faith, superior skill and careful
judgement required of him, that a continuation
of the experiment is likely to result in injury,
disability, or death to the experimental subject.

Informed Voluntary Consent

The German physicians tried at Nuremberg were
charged with conducting human experimentation
without the consent of the inmates.
AS a significant aftermath of such horrible experiments,
the idea of informed consent, was born.

Informed Consent

is understood as knowing of an
individual or his/her legally authorized
representative, so situated as to be able
to exercise free power of choice, without
undue inducement or any element of
force, fraud, deceit, or other form of
constraint or coercion

Information Element
Explain the procedures and their purposes and make
clear which are experimental
Underscore the risks and discomforts that can be
reasonably expected
Describe the possible benefits that the research will
yield
Point out appropriate alternatives that might be helpful
to the subject
Offer to answer any questions about the procedures
Make it clear to the subject that he/she is free without
penalty to withdraw consent and abandon the research

Justifications of
Human
Experimentatio
ns

Despite the moral horrors

that were divulged at
Nuremberg,
health
professionals still feel the
need
for
medical
experimentation involving
human subjects.

Investigations
involving
nonhuman organisms are
essential,
but
ultimate
tests of the correctness
and
effectiveness
of
medical treatments must
involve human beings as
research subjects

Animal
studies
are
inadequate
precisely
because human physiology
and
psychology
are
different and unique

Contemporary Medicine
Contemporary
medicine could not
have developed into
what it is today if not
for human
experimentations
Contemporary
Medicine conducts
studies and research in
which data are collated
to test hypotheses and
general theories
related to their disease
and treatment

 The development of polio

and smallpox vaccination,
for example, as well as
the treatment of herpes,
hepatitis, AIDS, TB, and
many other medical
advances in the call of
public health are mainly
attributed to the
experimentation with
human beings

Experimentations
on
human
subjects
is
necessary if we want to
develop new drugs,
new therapies, or new
preventives for serious
disease
It is necessary for the
sake of the common
good of the human race
to
develop
certain
vaccines and drugs that
stop the spread of
contagious diseases

Therefore If human
experimentation is a
necessary
prerequisite for the
development
of
drugs and vaccines,
then it seems to be a
moral
duty
to
experiment
on
humans

The moral issue

The
basic
moral
issue,
however, is that the purpose
of human experimentation is
not to help this patient (who
now
is
the
experiment
subject) but to advance
medical knowledge so that
future patients (suffering
from the same ailment as
the experimental subject)
may be healed
This leads to the distinction
between therapeutic and
nontherapeutic experiments
because
in
effect
this
experimental patient is now
being treated as a means for
the benefit of future patients

Medical Therapy vs Medical Research

Medical therapy focuses more on
a particular patient, whose wellbeing is their primary concern

Medical Research is interested in the

effectiveness of therapies in ending
disease processes and restore
functioning

Drug
Testing
and the
Use of
Placebos

Drug Testing refers to the medical procedure whereby

a new drug is tried and experimented to determine its
effectivity, usefulness, and other effects

The procedure is twofold:

Preclinical Testing it is done on
animals
Clinical Testing conducted with
human beings as experimental
subjects

Preclinical Testing
Determines:
Therapeutic index
Indicate the exact dosage of a therapeutic drug
Determine the drugs effects on body tissues and on particular
organs
Check for side effects and hazards

Clinical Testing
Conducted in three phases
First Phase: To determine whether it
produces toxic effect
Second Phase: It is tested on a limited
number of patients that can benefit from it
Third Phase: If the drug produces desirable
results then it is administered to a large
number of patients by a large number of
clinical investigators

Placebo
Clinical Placebo is a medically harmless ineffective
substance (sugar or dummy pill) that is usually used in
testing a new drug when it is given to a control group

Single-Blind Test
Single-blinddescribesexperimentswhere information
that could introduce bias or otherwise skew the result is
withheld from the participants, but the experimenter will
be in full possession of the facts.
In a single-blind experiment, the individual subjects do
not know whether they are so-called "test" subjects or
members of an "experimental control" group.

Double-Blind Test
Double-blinddescribes an especially stringent way of conducting
anexperimentwhich attempts to eliminate subjective,
unrecognized biases carried by an experiment's subjects
experiments are regarded to achieve a higher standard of
scientific rigor than blind or non-blind experiments.
In these double-blind experiments, neither the participants nor the
researchers know which participants belong to thecontrol group,
nor the test group. Only after all data have been recorded (and, in
some cases, analyzed) do the researchers learn which participants
were which. Performing an experiment in double-blind fashion can
greatly lessen the power of preconceived notions or physical cues
(e.g., theplaceboeffect,observer bias,experimenter's bias) to
distort the results (by making researchers or participants behave
differently from in everyday life).

Justifications of the Use of Placebos

Paternalistic Defense:
Justifies the use of placebos in clinical drug testing through
its therapeutic effects on the experimental patients
themselves. It is being carried out for their own good and
for others who are similarly situated
Utilitarian Defense:
- Considers placebic experiments as acceptable insofar as it
promises to benefit the whole of society in many instances
and not only the experimental subjects