Medical Experimentation and Research (humans and animals)

INTRODUCTION

We have both animals and humans subjected to experiments and research but the ethical leaning the two get are very different based on blur
gray rationale.

MEDICAL EXPERIMENTATION AND RESEARCH – ANIMALS

We all know for a matter of fact the symbiotic relationship between humans and animals dates back to when first permanent settlements
had stared to come into picture. The animals were provided all the necessary articles which would help them thrive and in return the
domesticator would benefit from the animal’s product, labor or life. This type of symbiotic relationship prevented the humans from
harming the animals as harming would mean harming themselves.

And then technological development shifted from the traditional way of farming to “factory farming”, eventually destroying the
symbiotic relation that had previously existed. Soon vaccines and antibiotics allowed animals to remain productive even while staying in a
stressful and harmful environment. This type of intense technolized farming became an open door to conducting research on animals.
Traditionally pain infliction on animal was labeled as cruel as long as it was purposeless and sadistic in nature but the era of research on
animals was looked at the same way as even though the animals were being harmed it was for a purpose and not sadistic in nature it was then
justified by ‘for the greater good’. This development exposed the limitations of the traditionally claimed “cruelty against animal” and urged
people to morally evaluate the field of animal research.

From the past centuries animals have been used in different fields of research; for biological, behavioral, or psychological research;
applied basic biomedical and psychological research; for the development of drugs and therapeutic chemicals; food and fiber research; for the
testing of various consumer goods for safety, toxicity, irritation; for educational demonstration and for extraction of drugs and biological
products. All of which go to vain most of the time since everything works on animals but not all that have seen success on an animal
seem to work for humans. The 1970's was the beginning year for philosophers’ contemplation on the moral reservations about human uses
of animals in general. Peter Singer and Bernard Rollin both in their respected books pointed out, challenged and demanded a justification for
harming the animals in the research process which was driven by the motive of ‘advancing scientific knowledge’. Rollin in addition even
pointed out the condition in which the animals were kept in which is more harmful to the animals then the physical experiments itself.
Different philosophers, various points of views, all of them had one common thread that being ‘arguments questioning the moral
acceptability of invasive animal use’.

MORAL CRITIQUE OF RESEARCH ON ANIMALS

“there appears to be no morally relevant difference between humans and at least vertebrate animals, which allows us to include all humans
within the full scope of moral concern and yet deny such moral status to the animal”

Few of the first arguments that were raised in critique of animal research were based on ‘disenfranchised humans’, the same logic had been
applied to the treatment of animal. How can we differentiate animals and humans while we all come from the same animal kingdom? We are
vertebrates and even closer mammals. Rollin provides us with the example of a teacher being biased based on the eye color of the student,
which would be seen by most as morally wrong. One of the most used arguments by the researcher is that of animal not having reason or soul
or interests like humans do when we all are very well aware that they(animals) do indeed have interests which just are not like human
interest. This justification according to Rollin does not mark any morally relevant difference for us to treat something as a lesser being and
exploit them.

“the interest of animals that are violated by research are patent”

The animals subjected to experiment certainly go through physical pain but the most degree of severe damage is the of the psychological
aspect. They get deprived of their natural habitat, kept in cages, isolated. What happens when a human, a social being like most of the other
animals are kept in isolation? There is high chance of heart disease, cognitive damage, depression and risk of insanity. So how can animals be
any different? It’s not like there aren’t humans being researched on and this is where the concept of informed consent steps in. This concept of
informed consent is applicable to the so called ‘marginal humans’ which includes infants, mentally unsound people, comatose etc. This
justification based on reason is thoroughly flawed. If the lack of superior intellect in animals allow us to inflict pain and experiment on them
then why isn’t this same principle applicable when it comes to marginal humans. There seems to be no morally relevant difference between
an animal and a less intellectual being, both of them are capable of feeling pain, stress and suffer infact a fully conscious non-human being is
able better comprehend things and as well have a greater number of interest than compared to an infant or a retard. Rollin mentions that
animal use in studying psychological states that appear in human is more fallacious as it gives rise to psychologist’s dilemma: one, if the state
produced in the animal is analogous to humans, what are the moral grounds for us to give rise of that state I the animals and two, if the states
produced in the animals are not analogous why create it in the first place.

RESEARCH COMMUNITY’S POINT OF VIEW

It is most natural for the research community to abstain from getting entangled with the moral outlook of the activity, even when faced with
questions regarding it they would answer “animal use is not a moral issue, it is a scientific necessity”. This position of the research
community is based on the scientific ideology/commonsense of science. This ideology was the result of trying to separate science from
philosophy and was later fueled by the logical positivism movement.

The scientific ideology had a profound impact on the way people viewed animal research;

1. The scientific realm discarded the ethical issues from the preview of science because moral judgements could not be proven
empirically. They simply viewed ethics as emotions and would not be valid until it was backed up by vivid accounts of human
suffering.
2. Scientific ideology strongly supported the non-involvement of ethics in science. Only the intersubjectively observable was to be
included in science like the mental behavior and not the mental state. The pain that an animal feels is a mental state and since
mental state is not an intersubjectively observable researchers feel that it is none of scientific concern.

One of the major comebacks of the researchers is the argument of ‘benefits’, more of a utilitarian approach i.e., harming few animals for the
benefit of the entire human race. It is true in most of its part that animal research as given the human race breakthrough in field of drugs,
operative procedures which have helped humans to a great extend and most of it wouldn’t have been possible if it weren’t for the animal use.
This argument does justify the use of animals to some extend but was countered by the other party in two ways;

1. There is no connection between the premise and the conclusion. Positive results of the experiments does not follow with the moral
question of these experiments. Rollin has provided us with the Nazi human experiment example. The experiments conducted in
the Nazi camps, the scientific data collected them were of value in area of hypothermia and high-altitude medicine but it is
considered immoral to use this data or even cite this data regardless of how beneficial they are for the other civilians. The only
way to counter this argument would be for them to provide a morally relevant difference between animals and humans.
2. The second fallacy in benefit argument is its second premise that the benefits could not have been achieved through other means.
How do we know that when we they haven’t tried other means? It might still be possible since there have been recent development
on cell wells which allows the generated cells to be tested upon.

Other argument in favor of the researchers given by Carl Cohen was that, only beings having rights can claim their ‘moral status to be
protected from invasive use in research’ and since animals cannot reason which are necessary condition to be a right bearer they do not need
to be protected from the invasive use. According to Rollin that could not be the case, he writes that even if the concept of rights arose because
of ration beings it does not mean that it is only limited to them and not other beings. Since we created it, it is well within our jurisdiction to
extend it and make it more inclusive of other beings infact this has happened before in history regarding women’s rights.
This argument has a number of issues. First off, even if only among intelligent beings does the idea of a right (or of sufficient moral standing
to prevent one from being used carelessly for the profit of others) originate, it does not follow that its application is restricted to such beings.
Think of a comparison. Chess may have been created specifically so that Persian nobility could play it. However, because the game's rules
have a life of their own, anyone can play it, regardless of the creators' original intentions. Cohen responds that this extension is acceptable
since marginal people are a rational species. but animal extension is not However, the obvious retort to this is that, according to his own
reasoning, being rational is relevant, not belonging to a certain sort. Additionally, if his claim is true and the ethically significant aspect is
carelessly disregarded, Cohen's position could be reversed. Similar reasoning might be used to claim that since people are animals, albeit
rational ones, and other animals are also animals, however non-rational ones, we should disregard rationality simply because both humans
and animals are members of the same kind (i.e., animal). He fails the moral relevance test by providing an exception for non-rational humans,
which renders the arbitrary inclusion of animals as right-bearers as rational as the arbitrary inclusion of non-rational humans.

A theoretically competent defense of Cohen's assertion that morality only applies to rational beings could be used to exclude animals from
direct moral standing and justify invasive experimentation on them. The work of John Rawls more recently brought this viewpoint, which has
its contemporary roots in Hobbes but was actually articulated even in antiquity, to public attention. The neo-Cartesian argument has been
directly applied to the issue of animals' moral standing by Peter Carruthers. It's interesting to note that Carruthers' contractual defense stands
alone from his denial of animal consciousness. Animals are not given the moral position essential to call into question the morality of
experimentation on them, according to Carruthers, even if they are conscious and feel pain.

MEDICAL EXPERIMENTATION AND RESEARCH – HUMANS

In the field of research animals are not the only beings exploited, many a times humans too get exploited by the powerful agents who conduct
such experiments for their own selfish needs. Since we have seen a growth in the multinational researches conducted in developing countries
it has given rise to many ethical concerns. There have been many instances in history where humans were exploited for scientific gain.

The Nazi Experiments:

The abuse done to the human race during WW II was one of the main factors that pushed the authorities to revise the ethics in researches.
People were forced to drink sea water in order to record how long a man could survive without fresh water, people were drowned in icy water
in order to find effective heating techniques, prisoners were exposed to phosgene gas and were infected with pathogens as they were trying to
find the antidote. Hundreds died and many who survived had to live with painful physical and psychological traumas, yet the experiments did
not stop as they had “human material” at their disposal. The Nuremberg trail that was conducted gave us the Nuremberg code which states in
its first article “the voluntary consent of the human subject is absolutely essential”.

The Tuskegee Syphilis Study:

Many African American men during 1930’s suffered from secondary syphilis, 1945 – penicillin was found to be an effective treatment for the
same but these men from the rural setting were made deprived from it. The reason being that if these men were cured then no one would ever
get to know the long-term effects of syphilis. The treatment was withheld from these men without their consent.

Jewish Chronic Disease Hospital:

In the year 1964, 22 elderly patients in the Jewish Chronic Disease Hospital were injected with live cancer cells to study the human body’s
immunity system. The subjects were only provided with vague information like a tissue will be injected in them and it might as well form a
lump but nothing to rally worry about since it would disappear after a few days. The researcher knew that it wouldn’t cause cancer and just
wanted to know fast would the immune system reject the tissues. And as per the informed consent, he defended himself by saying that
mentioning the word ‘cancer’ would have made the research subject scared. Even though none of the elderlies were harmed they were
definitely harmed.

FUNDAMENTAL ETHICAL PRINCIPLES FOR RESEARCH

The spirit/or the ethical principles for research was derived from Western Philosophy, it consists of three main principles respect for person,
beneficence and justice. These three principles have been accepted and acknowledged as governing research design throughout the world.

RESPECT FOR PERSON: INFORMED CONSENT

There is a huge gap that exists between the ideal idea of informed consent and the reality. There should be enough information about the
research provided to the subject for an informed choice to be made. The information has to clear and in simple language so that everyone
(uneducated, illiterate) can understand. The consent must be voluntary and given without pressurizing and exerting the potential subjects.
Despite knowing all these the informed consent document still remains filled with medical jargons and not at all ‘user friendly’.

One of the main obstacles that exists regarding an informed consent is ‘the therapeutic misconception’, this happens when the subject does
not read the informed consent because they trust their doctors or physicians. It is important to distinguish between physician - patient
relationship i.e., receiving an established treatment and a researcher – subject relationship i.e., investigating new, unproven therapies.

Informed consent in developing countries:

It is only natural to assume that developing countries are lacking in the field of informed consent due to their low literacy rate, unfamiliarity
with biomedical research and their limited health care facilities, however Pace et al.2003 wrote, “there are indeed warning signs about
participants’ comprehension and whether they are acting voluntarily, but in contrast to some claims, these warning seem to apply to both
developed and developing countries”.

Cultural difference is one of the obstacles that informed consent has to face. Countries which do not follow the western ideals such as
Vietnam prefer a different way of discloser of information and communication with the doctor i.e., paternalized practice of medicine. The
patients do not take part in the decision making and completely rely on what the doctor has to say. The researchers had to withhold any
information from the patients if it came out as an uncertainty from the doctors’ part. Because of these constrains it resulted into vague, less
detailed informed consent which made it unclear for the researcher if the subject understood that their treatment was determined by chance.
Such cases give rise to the debate revolving around withholding key information from the participants. The apparent necessity to conceal
important information from potential research volunteers is one instance where ethical relativists have advocated departing from the generally
recognized ethical requirements for informed consent.

Supporters of such deviations offer three different arguments.

- The first is that the cultural context in the nation or community where the research is being done justifies the departures. This is
predicated on the commonly held belief that researchers ought to be sensitive to cultural differences.
- Second, researchers claim that these deviances from what they refer to as "Western" informed consent criteria make it impossible
to do research otherwise. The rational defense is presented here.
- The third point follows naturally from the second: enforcing adherence would prevent those nations or communities from making
valuable contributions to medical knowledge and preventing their citizens from reaping the advantages that would follow. The
implications of not performing the research in the developing country are mentioned in this appeal to justice. The conflict between
 the ethical criteria of informed consent and the need to maintain cultural sensitivity, both of which are mentioned in international
norms, makes it difficult for research to be undertaken in multicultural settings and in the international context.

BENEFICENCE

Researchers have an obligation to comply with the principle of beneficence, the spirit of the research is that of a utilitarian. The subjects take
part and the future, gets benefitted by it, these projects aim at maximizing potential benefits and minimizing harm. The theory of beneficence
is hard in practice as these is no practice for an established methodology for balancing risk and benefit. It is difficult to predict the benefits in
the early stages of the research and these researches do not provide direct benefits to the subjects.

“Gold Standard” Methodology and Ethics:

Research projects must adhere to strict methodological standards and be well-designed in order to satisfy the criterion of beneficence.
Research that is poorly planned cannot be of any use to participants or others. The long-running debate over whether placebos, or inactive
substances, should be used to compare with an active experimental drug in a clinical trial, is one significant cause for concern. There are
numerous methodological explanations for this. Sometimes it makes sense to contrast an experimental drug with a placebo. The circumstance
in which there is just no known cure for a medical disease is the least ethically troubling. In that situation, the trial's goal is to determine
whether the experimental drug is superior to nothing. The placebo is created to mimic the study drug because excellent scientific technique
requires that neither the researcher nor the participant know which product is being administered. But even if there is an effective treatment
for the illness being studied, using a placebo to compare with an experimental medicine raises ethical concerns. Supporters contend that
certain illnesses progress differently than others, some recover on their own, and still others are influenced by patients' expectations of how
well a medicine will make them feel (the so-called "placebo effect"). For the aforementioned reasons, drug regulatory authorities often require
or highly prefer placebo-controlled trial designs.

Some claim it is immoral to deny participants in clinical trials access to effective, proven treatments. The claim is that it is unethical to
intentionally make research participants worse off than they would be without a clinical trial. It is against the law to deny research subjects a
medicine that is currently available and that they could have from their own doctors if they weren't participating in the experiment.

For example, the case of AZT trail. In this trail pregnant women with HIV from developing countries were given lower dose of AZT than
compared to that in US since they were cheaper. The research's detractors claimed that many lives may have been saved if the therapy utilized
in wealthy nations, which has been shown to lower the incidence of HIV infection in newborns, had been administered to the women
participating in the trials. The following main points were made in response by those who supported the study (not all defenders invoked all
of these justifications).

- First, it was argued that since receiving no treatment at all is considered "standard of care" for HIV-positive women in these
underdeveloped nations, participation in the study does not negatively impact them.
- Second, advantages to this population might be available much sooner since a placebo-controlled trial can be conducted with
many fewer participants and be finished much faster than a research with an active treatment in the control arm.
- The pricey AT therapy that is now considered conventional in the West is not, and it never will be, according to a third defense.
This population, making its use in a research project unjustifiable.

The main ethical issue raised by the detractors was that these studies compared the experimental treatment to a placebo when they could have
utilized the standard treatment employed in the industrialized world. In that circumstance, no woman in these studies would have been denied
access to a treatment that has been shown to be beneficial or may be successful. However, this trial brings up yet another ethical issue with
respect to study done in underdeveloped nations.
JUSTICE

It has been mentioned before in Plato’s republic that justice is when the communities do their respective jobs properly i.e., in a fair manner.
So, justice in the field of research focuses on the fair selection of subjects. It would be unjust to a great degree if the subjects to a research
come mainly from poor countries but the ones receiving the benefit from the middle and upper class. This mostly happens when researches
are sponsored by industrialized countries in a resource – poor country.

‘what if anything, does justice require when industrialized countries sponsor or conduct research in resource – poor countries?’

There has been an attempt to answer this question:

- The research need to be responsive to the medical needs of the population where the research is taking place.
- Not acceptable if the condition of the subjects gets worst after or during the research i.e., by not providing the treatment that they
need after the tests are over.
- Not acceptable if the developed countries leave nothing behind after the research i.e., providing post trail benefits.

All of these concerns and questions eventually led to the revision of the Declaration of Helsinki since it had not included any statement
regarding post – trail benefits to the subjected communities. It was later amended in two parts; para 19, ‘medical research is
only ...............from the results of the research’ and para 30, ‘at the conclusion of the study, every patient..............therapeutic methods
identified by the study’. Both of which faced criticism, people were skeptical about the strong requirements and the criteria which determined
‘likelihood of benefits’.

CONCLUSION

It is evident that it is mainly the vulnerable groups that get subjected to and get exploited by the hands of researchers. When people realized
that running research programs on humans were unethical and had to followed with proper research protocols like informed consent, fair
selection, post-trail benefits the weight of such researches are not borne by animals. The very reason that makes conduction research on
marginalized unethical is what makes researches on animals unethical too, infact animals are more vulnerable than compared to humans as
they do not get the privilege of informed consent nor post-trail benefits. Most of the animals subjected to such research programs get
euthanized instead of receiving proper treatment. Whereas in case of informed consent as Steve Sapontzis mentioned ‘open the gates!’ and
this would definitely make it clear if the animal is consenting to a research or not.

I firmly believe that the entire scientific research concerning living organism started off with a wrong foot. Even though the objective and the
bigger picture was for the betterment and had utilitarian views humans opted for the lazier way through it. They reached out to the most
convenient resources for the research i.e., humans themselves and animals. After decades of animal and human research, some scientists have
finally started looking for alternatives which can mimic a living organism for a research, this alternative is called ‘cell wells’ where a small
slide containing live cells are injected with whatever viruses and nobody gets harmed. If only instead of readily using animals and humans for
their deposal had they spend their time and resources in developing alternatives humans and animals would have been kept away from
exploitation.

On the other hand it is true that nothing can go out in the market unless let has been tested on humans and yes researches are necessary for
scientific benefits hence that these contradicting points point out that the ethics regarding research needs to be thoroughly revised.