standard. Again, this is principally a deductive
approach, and not very far from Kant’s categorical
imperatives.
Objectivism versus subjectivism
A final consideration is whether ethical principles
are relative or absolute. Ethical objectivism
(Kant’s categorical imperatives fall under this
heading) asserts that ethical solutions are always
absolute. In contrast,ethical subjectivismmain-
tains that ethical solutions are never absolute.
Ethical relativism(cultural relativism) provides
a compromise, which may or may not be ‘correct’,
that ethical behavior should be judged relative to
the norms of one’s culture: what may be wrong for
one society may be right for another, and this is
clearly a utilitarian principle; an example may be
the difference between civilian and military
healthcare. In the civilian world, ‘every patient
deserves the very best treatment’ is the ideal,
and is an absolute ethical objective. At a field
dressing station, where medical staff and their
equipment may be suddenly overwhelmed, triage
is practiced with the aim of providing the greatest
benefit for the greatest number. Thus, on the bat-
tlefield it will not be the case that every wounded
soldier gets the best medical care, and this is an
example of utilitarianism and ethical relativism.
Both medical practices are ethically sound (or
‘correct’), and the termuniversal prescriptivism
wasformulated by R.M. Hare (1919–2002) to
describe such combinations of Kantianism and
utilitarianism.
Four basic principles
When using these formal tools, there are four basic
domains of bioethics wherein they are applied.
These are the following:
Beneficence: Is every action oriented toward the
benefit of the individual?
Nonmaleficence: Is any action not oriented
toward the benefit of the individual? (note that
nonmaleficence is included under ‘beneficence’
in the Belmont Report)
Autonomy: Does every individual agree with
every action applied to him or her?
Social justice: Is every action compatible with
the standards of the population?
Although these principles are particularly relevant
to the conduct of clinical studies (see below), they
may also apply to the ordinary practice of medicine
and, indeed, all situations where one human being
has a responsibility to care for another human
being. Let us not forget that the fundamental
goals of healthcare, even in this age of rapid tech-
nological progress, are to cure sometimes, relieve
often and comfort always, and this should not be
violated in the context of clinical studies.
45.3 Ethics of human
experimentation
Protection of the research subject in clinical trials
poses a number of bioethical questions. We have
already mentioned beneficence (the anticipation of
some benefit), nonmaleficence (freedom from
harm), autonomy (free participation without coer-
cion) and social justice (whether or not there is a
duty for people to participate in clinical studies, as
benefactors of those who have previously volun-
teered). Each of these needs further discussion.
These domains were egregiously violated by var-
ious governments during the twentieth century
(German Nazis, Tuskegee, etc.). It was the
Nuremberg code that first provided for the protec-
tion of the research subject, and the Declaration of
Helsinki, as amended, is its successor.
Above all, the rights of the individual must
be seen to trump any need or possibility of scien-
tific advance. The duty toward the individual
must always have a far higher priority than some
intangible benefit that might attach to the popula-
tion as a whole in the future. In protecting the
research subject, the first principle is ‘informed
consent’.
590 CH45 INTRODUCTION TO BIOETHICS FOR PHARMACEUTICAL PROFESSIONALS