Globalization of Clinical Research Global clinical researches have many shades of grey to it. A majority of the medical advancements happen in the name of clinical trials are conducted on the poorer, powerless, and helpless patients. This practice seems unethicalas it is embraced by pharmaceutical companies as a part of their profitable business plans. One of the most famous yet disturbing example of such researches is the experiments performed in the Nazi concentration camp inmates during the Great wars. Firstly, for the operations of clinical trials drug industries often conduct their researches in areaswhere the population is poor and this significant segment of poorer population is located in abundance. Almost all the major pharmaceutical companies’ targets developing countries like India, Africa and Latin America for their trials, when the drug is meant for use outside these geographic locations. The drugs tested in these areas’ population may not be for the diseases prevalent in these geographic locations. This means that these countries would most likely not be able to reap the benefits of such trials health wise.Yet another concern to the story is whether or not the drug upon approval would be available for use in those countries where it was tested, if necessary. These uncertainties suggest the unjust behavior of the globalized clinical researches. The main objective of the clinical researches is to collect data. In addition to these, placebo groups for the drugs tested are also from these underdeveloped world rather than from the developed world such as the U.S.A and Western Europe, despite FDA preferences. This means the placebo would receive minimal medical attention ultimately leading to their death, thus helping the industries get their so-called valuable data through ruthless human sacrifices. Every human life is precious and a gift of God. This is immensely unfair if the helplessness of the people in the underdeveloped world is misused. The overall concept of the Doctrine of Double Effect is thata harmful effect is permissible if and only if the overall good effects outweighs the bad effects. In this case study, however, human lives are risked and pitted against drugs whose direct benefits might not be actually be useful to the nations lives being risked. In addition, there could be a high possibility of failure in the drug performance, as the genetic profiles of trial population might be different from target population. This could significantly alter the safety and effectiveness of the drugs. Ethically speaking, the industries must focus on drugs that actually cure the diseases prevalent in the areas where trial population is located. The availability of the drugs after approval to the population being tested if needed is yet another important factor. Human lives all across the globe must be treated with equal respect and values. Only these can bring about globalization of clinical research in its truest sense. Medical E ...

1. Globalization of Clinical Research
Global clinical researches have many shades of grey to it. A
majority of the medical advancements happen in the name of
clinical trials are conducted on the poorer, powerless, and
helpless patients. This practice seems unethicalas it is embraced
by pharmaceutical companies as a part of their profitable
business plans. One of the most famous yet disturbing example
of such researches is the experiments performed in the Nazi
concentration camp inmates during the Great wars.
Firstly, for the operations of clinical trials drug industries often
conduct their researches in areaswhere the population is poor
and this significant segment of poorer population is located in
abundance. Almost all the major pharmaceutical companies’
targets developing countries like India, Africa and Latin
America for their trials, when the drug is meant for use outside
these geographic locations. The drugs tested in these areas’
population may not be for the diseases prevalent in these
geographic locations. This means that these countries would
most likely not be able to reap the benefits of such trials health
wise.Yet another concern to the story is whether or not the drug
upon approval would be available for use in those countries
where it was tested, if necessary. These uncertainties suggest
the unjust behavior of the globalized clinical researches.
The main objective of the clinical researches is to collect
data. In addition to these, placebo groups for the drugs tested
are also from these underdeveloped world rather than from the
developed world such as the U.S.A and Western Europe, despite
FDA preferences. This means the placebo would receive
minimal medical attention ultimately leading to their death, thus
helping the industries get their so-called valuable data through
ruthless human sacrifices. Every human life is precious and a
gift of God. This is immensely unfair if the helplessness of the
people in the underdeveloped world is misused.
The overall concept of the Doctrine of Double Effect is

2. thata harmful effect is permissible if and only if the overall
good effects outweighs the bad effects. In this case study,
however, human lives are risked and pitted against drugs whose
direct benefits might not be actually be useful to the nations
lives being risked. In addition, there could be a high possibility
of failure in the drug performance, as the genetic profiles of
trial population might be different from target population. This
could significantly alter the safety and effectiveness of the
drugs. Ethically speaking, the industries must focus on drugs
that actually cure the diseases prevalent in the areas where trial
population is located. The availability of the drugs after
approval to the population being tested if needed is yet another
important factor. Human lives all across the globe must be
treated with equal respect and values. Only these can bring
about globalization of clinical research in its truest sense.
Medical Ethics
Religious and Secular Ethics
Divine Command Theory
Essentially this is the theory that is based upon what God deems
as right is right and what God deems as wrong is wrong. What
God expects of us derives from his immutable moral nature.
Thus since God’s nature is unchanging our moral obligations
are fixed, unchanging, and absolute.
Scriptural Basis

3. Augustine believed that the divine command theory could be
deduced from the scripture. That if we were to follow the Bible
we would be following God’s command.
Augustine felt that the Bible was the chief source of Christian
Ethics.
Natural Law Theory
Aquinas’ theory is based upon the idea that the world was
created by a supremely rational being (God) and that all things
created were given a specific role or purpose. And thus since
good is seen as a natural end, humans are naturally inclined
towards it.
Aquinas reasoned that, because God created the world and
everything in it with an order and a purpose reflective of his
will, by examining the nature of things we should be able to
discover what God expected of us. (36)
In other words, the mental powers given by God for discerning
his existence has also enabled us to discern moral law.
Aquinas argues that things that we are naturally inclined
towards are good. The examples he gives us are:
1. preservation of self
2. education of offspring, reproduction of species and so
forth
3. natural inclination to according to the nature of his
reasoning, leading to know the truth about God, live in societies
and thus follow the natural law.

4. The Doctrine of Double Effect
The principle of double effect recognizes that sometimes it is
permissible to bring about, as a merely foreseen side effect, a
harmful event that it would be impermissible to bring about
intentionally.(37)
The Doctrine of Double Effect (cont.)
Specifically , under the doctrine of double effect, a harmful
effect is permissible if and only if:
1. the act itself is morally good or neutral;
2.only the good effect of the act is intended directly;
3. the bad effect of the act is not the means for achieving the
good effect;
4. the good effect outweighs the bad effect.
Ordinary vs. Extraordinary measures
Ordinary refers to all reasonable and beneficial medicines and
treatments that can be obtained and used without excess burden
on the patient.
Extraordinary refers to all medicines and treatments that can be
obtained or used only with excessive burden to the patient or
ones that wouldn’t offer the patient reasonable hope of benefit.
According to the ordinary/extraordinary distinction, a patient is
not morally obligated to use any means, natural or artificial,
that does not offer a reasonable hope of curing the patient’s

5. condition. (37)
Self-evidence of Natural Law
Aquinas’ said that “a thing is said to be self-evident in two
ways: first, in itself; secondly, in relation to us. Any
proposition is said to be self-evident in itself, if its predicate is
contained in the notion of the subject…”
For example: Man is a rational being. This idea is self-evident
in the fact that men can reason and thus are rational by nature.
The second way takes the practical reasoning of man to be self-
evident. In other words without the ability and knowledge of the
subject nothing is self-evident about it. But since we have these
abilities they become self-evident, such as the ideas of good and
evil.
Secular Natural Law
John Locke’s formulation of natural law theory is based on our
observations of nature itself.
Locke derived certain inalienable rights which flowed from
nature’s laws, those being life and liberty.
He said that it was precisely and only to protect these natural
rights and ensure equal treatment against the threats to them
posed by conflicting and unrestrained self-interests that people
formed societies. (38)

6. Legal and Moral Rights
Legal rights are those that we retain under a government. The
right to vote for example.
Moral rights (human rights) refer to those that we hold on the
basis of our humanhood.
Whereas a legal right is derived from law or a legal system, a
moral right is derived merely from being a human being. (38)
Social Contract Theory
Idea put forth by Thomas Hobbes - It is the claim that it is the
people who bring the state or government into being to secure
and promote their basic rights and well-being. Empowering
civil authority to spell out legal rights based on natural or moral
rights, presumably to ensure the requisite mutual trust for the
social cooperation needed to protect those rights. (39)
Essentially, we all agree to live together to maintain our
personal rights and in order to do this we give up control of
certain rights to ensure the preservation of the others.
Kantian Ethics
Believed that there all duties could be derived from the
categorical imperative. We may only act and are bound to act
in such a way that it doesn’t violate either premise of the
theory.
Kant claims that there is only one thing that is good without
qualification: good will.
“a good will is not good because of what it effects or
accomplishes –because of its fitness for attaining some
proposed end: it is good through its willing alone – that is, good

7. in itself.”
Moral Choice
According to Kant, by telling us what to do…reason enabled us
to go beyond natural instinct and narrow self-interest. Reason
told us what principles of action had the force of an
unconditional moral duty, …one that is universal and absolute;
one that always applied, unexceptionally to all rational
creatures. (42)
He termed this universal basis of moral obligation the
categorical imperative.
The Categorical Imperative
Two formulations of the theory:
Principle of Reciprocity - “act only on that maxim through
which you can at the same time will that it should be universal
law”
Principle of Humanity - “act in such a way that you will always
treat humanity never simply as a means, but at the same time as
an end.”