This document discusses the ethical issues surrounding the use of living organisms in biomedical research. It begins with a brief history of animal experimentation dating back to ancient Greece. While early experimenters faced few objections, concerns grew in the 19th century as anesthesia became available and domestic pets became more common. The development of utilitarian philosophy also questioned whether animals could experience pain or pleasure. As views on animal sentience changed, defenders of animal research had to provide stronger moral arguments to justify experiments that caused animal suffering. The document examines these historical perspectives to inform current debates around using animals in medical studies.

1. MEDICAL ETHICS
PRESENTATION ON
DIGNITY & IMMUNITY OF HUMAN LIFE FROM MOMENT OF FERTILIZATION TO NATURAL DEATH
USING OF LIVING OBJECTS IN BIOMEDICAL RESEARCH.
ALTERNATIVE METHODS OF BIOMEDICAL RESEARCH
NAME : CRISPIN MALVIKA
GROUP: 5

2. The dignity of a person must be recognized in every human being from conception to natural death. This fundamental
principle expresses a great “yes” to human life and must be at the center of ethical reflection on biomedical research, which
has an ever greater importance in today’s world
The teaching of Donum vitae remains completely valid, both with regard to the principles on which it is based and the
moral evaluations which it expresses. However, new biomedical technologies which have been introduced in the critical
area of human life and the family have given rise to further questions, in particular in the field of research on human
embryos, the use of stem cells for therapeutic purposes, as well as in other areas of experimental medicine. These new
questions require answers. The pace of scientific developments in this area and the publicity they have received have raised
expectations and concerns in large sectors of public opinion
In the current multifaceted philosophical and scientific context, a considerable number of scientists and philosophers, in the
spirit of the Hippocratic Oath, see in medical science a service to human fragility aimed at the cure of disease, the relief of
suffering and the equitable extension of necessary care to all people. At the same time, however, there are also persons in
the world of philosophy and science who view advances in biomedical technology from an essentially eugenic perspective

5. Anthropological, Theological and Ethical Aspects of Human Life and Procreation
In recent decades, medical science has made significant strides in understanding human life in its initial stages. Human biological structures and
the process of human generation are better known. These developments are certainly positive and worthy of support when they serve to
overcome or correct pathologies and succeed in re-establishing the normal functioning of human procreation. On the other hand, they are
negative and cannot be utilized when they involve the destruction of human beings or when they employ means which contradict the dignity
of the person or when they are used for purposes contrary to the integral good of man.
The body of a human being, from the very first stages of its existence, can never be reduced merely to a group of cells. The embryonic human
body develops progressively according to a well-defined program with its proper finality, as is apparent in the birth of every baby.
It is appropriate to recall the fundamental ethical criterion expressed in the Instruction Donum vitae in order to evaluate all moral questions
which relate to procedures involving the human embryo: “Thus the fruit of human generation, from the first moment of its existence, that is to
say, from the moment the zygote has formed, demands the unconditional respect that is morally due to the human being in his bodily and
spiritual totality. The human being is to be respected and treated as a person from the moment of conception; and therefore from that same
moment his rights as a person must be recognized, among which in the first place is the inviolable right of every innocent human being to life”.
This ethical principle, which reason is capable of recognizing as true and in conformity with the natural moral law, should be the basis for all
legislation in this area. In fact, it presupposes a truth of an ontological character, as Donum vitae demonstrated from solid scientific evidence,
regarding the continuity in development of a human being.
If Donum vitae, in order to avoid a statement of an explicitly philosophical nature, did not define the embryo as a person, it nonetheless did
indicate that there is an intrinsic connection between the ontological dimension and the specific value of every human life. Although the
presence of the spiritual soul cannot be observed experimentally, the conclusions of science regarding the human embryo give “a valuable
indication for discerning by the use of reason a personal presence at the moment of the first appearance of a human life: how could a human
individual not be a human person?”.[8] Indeed, the reality of the human being for the entire span of life, both before and after birth, does not
allow us to posit either a change in nature or a gradation in moral value, since it possesses full anthropological and ethical status. The human
embryo has, therefore, from the very beginning, the dignity proper to a person.

6. BIOMEDICAL
RESEARCH

7. USING OF LIVING OBJECTS IN BIOMEDICAL RESEARCH.
INTRODUCTION
WHAT IS BIOMEDICAL RESEARCH?
BIOMEDICAL RESEARCH IS THE BROAD AREA OF SCIENCE THAT LOOKS FOR WAYS TO PREVENT AND TREAT
DISEASES THAT CAUSE ILLNESS AND DEATH IN PEOPLE AND IN ANIMALS. THIS GENERAL FIELD OF RESEARCH
INCLUDES MANY AREAS OF BOTH THE LIFE AND PHYSICAL SCIENCES.
UTILIZING BIOTECHNOLOGY TECHNIQUES, BIOMEDICAL RESEARCHERS STUDY BIOLOGICAL PROCESSES AND
DISEASES WITH THE ULTIMATE GOAL OF DEVELOPING EFFECTIVE TREATMENTS AND CURES. BIOMEDICAL
RESEARCH IS AN EVOLUTIONARY PROCESS REQUIRING CAREFUL EXPERIMENTATION BY MANY SCIENTISTS,
INCLUDING BIOLOGISTS AND CHEMISTS. DISCOVERY OF NEW MEDICINES AND THERAPIES REQUIRES CAREFUL
SCIENTIFIC EXPERIMENTATION, DEVELOPMENT, AND EVALUATION

8. Ethical Issues in the Use of Animals in Biomedical Research
Historical Perspectives
The use of animals in biomedical research has a lengthy history. Early Greek writings (circa 500 B.C.), for example, describe the
dissection of living animals by physician-scientists interested in physiological processes. These early vivisections appear to have
been done mostly for exploratory purposes, however, to describe the inner workings of animals. Later, Roman physicians--
including perhaps the single most influential figure in the emergence of the medical sciences, the physician Galen--began to
perform what we would now regard as the first genuine experiments involving animals. Using vivisections to test specific
hypotheses and explore competing explanations of biological phenomena, these early physician-researcher were among the first
advocates of the idea that the use of animals in research was morally justifiable in light of the potential health benefits
associated with those experiments.
Beginning with Galen, animal vivisection quickly emerged as an important tool for the study of anatomical structures and their
functioning. Remarkably, Galen’s teachings on human anatomy, which were widely used by physicians and scientists for nearly
1500 years, were derived from animal dissections and external examinations of the human body--he conducted no human
autopsies. Later, as modern scientific principles were increasingly incorporated into the study of human physiology, physician-
researchers such as Andrea Vesalius and William Harvey continued to employ animal vivisection in their investigations of the
functioning of various anatomical structures, particularly the heart and lungs.
Throughout this historical period, few philosophical or moral objections were voiced regarding the use of animals in biomedical
studies. This is perhaps surprising for two reasons. First, anesthetics were poorly understood and rarely used in animal
vivisections. Second, the medical benefits of using animals in research were at best ambiguous during this period. Although both
of these considerations would appear to argue strongly against the use of animals in research, there was clear moral consensus
that the practice of animal vivisection was not unethical.

9. A Changing Moral Landscape
In the early and mid 19th century, this moral consensus becomes less clear. The availability of general anesthetics and the increasingly popularity of domestic
pets (particularly in England), fueled anti-vivisection sentiments. By 1865, these reformist sentiments had become strong enough to prompt a response by the
medical establishment. In his work, Introduction to the Study of Experimental Medicine, Claude Bernard was among the first to advance a moral argument in
support of the use of animals in research. Arguing that the sacrifice of animals lives was essential to the advancement of medicine, and thus the relief of human
suffering and extension of human life, Bernard argued that animal experimentation was ethically acceptable.
Changes in moral philosophy around that time, however, made Bernard’s argument less compelling than it might have been were it introduced a generation
earlier. In the early modern period, prevailing metaphysical beliefs about non-human animals included the Cartesian notion that animals were non-sentient
automatons incapable of experiencing pain or pleasure. Only human beings were endowed with these special capacities, which they possessed in virtue of the
fact that they had souls (which animals lacked). However, the emergence of utilitarianism as an influential moral paradigm called this perspective into question.
Philosophers like Jeremy Bentham questioned whether animals truly lacked the capacity to experience pain or pleasure. In addition, Bentham argued that this
capacity was a defining feature of membership in the moral community. For him, all pain and suffering was important in the assessment of the moral
righteousness of an action, including pain and suffering that might be experienced by animals. If an action maximized good (pleasure) and minimized harm
(pain), to the fullest extent possible, then that action was morally correct. If not, then the action was subject to moral disapproval.
As the Cartesian paradigm became more suspect and moral sentiments became increasingly more concerned with the minimization of pain and promotion of
pleasure, including the minimization of animal suffering, defenders of animal experimentation were increasingly more subject to public scrutiny. In 1875, the
Society for the Protection of Animals Liable to Vivisection emerged as an important force in the anti-vivisection movement. In the following year, the public
reform campaign initiated by this organization was successful in establishing the first regulations governing the use of animals in biomedical research, the
Cruelty to Animals Act of 1876. Although it did not prohibit all animal vivisection, this Act did require the use of anesthetics for many types of animal
experimentation.
The passing of the Cruelty to Animals Act of 1876 was not altogether successful in answering the concerns of advocates on behalf of animal interests. Further
support for the use of animals in research would come shortly thereafter, however, with advances in immunology and the study of infectious disease. The use of
animals in the development of a vaccine for rabies and in the treatment of diphtheria provided compelling evidence of the health benefits associated with
animal experimentation. These breakthrough accomplishments demonstrated in a manner that had not been possible before that time, that the use of animals
in modern medical research could result in significant improvements in human health. Animal experimentation was now seen in a much less ambiguous way as
a critically important tool in the war against human (and animal) disease.

11. Why are Animals Used in Biomedical Research?
The use of animals in some types of research is essential to the development of new and more effective methods for diagnosing and treating
diseases that affect both humans and animals. Scientists use animals to learn more about health problems, and to assure the safety of new
medical treatments. Medical researchers need to understand health problems before they can develop ways to treat them. Some diseases and
health problems involve processes that can only be studied in living organisms. Animals are necessary to medical research because it is impractical
or unethical to use humans.
Animals make good research subjects for a variety of reasons. Animals are biologically similar to humans. They are susceptible to many of the
same health problems, and they have short life-cycles so they can easily be studied throughout their whole life-span or across several
generations. In addition, scientists can easily control the environment around animals (diet, temperature, lighting), which would be difficult to do
with people. Finally, a primary reason why animals are used is that most people feel it would be wrong to deliberately expose human beings to
health risks in order to observe the course of a disease.
Animals are used in research to develop drugs and medical procedures to treat diseases. Scientists may discover such drugs and procedures using
alternative research methods that do not involve animals. If the new therapy seems promising, it is tested in animals to see whether it seems to
be safe and effective. If the results of the animal studies are good, then human volunteers are asked to participate in a clinical trial. The animal
studies are conducted first to give medical researchers a better idea of what benefits and complications they are likely to see in humans.
A variety of animals provide very useful models for the study of diseases afflicting both animals and humans. However, approximately 95 percent
of research animals in the United States are rats, mice, and other rodents bred specifically for laboratory research. Dogs, cats, and primates
account for less than one percent of all the animals used in research.
Those working in the field of biomedical research have a duty to conduct research in a manner that is humane, appropriate, and judicious. CBRA
supports adherence to standards of care developed by scientific and professional organizations, and compliance with governmental regulations
for the use of animals in research.
Scientists continue to look for ways to reduce the numbers of animals needed to obtain valid results, refine experimental techniques, and replace
animals with other research methods whenever feasible.

16. An important ethical principle of animal use in biomedical research is that alternatives to live animals should be used
whenever possible. There is a legal requirement for documentation of a search for alternatives and an explanation for why
these alternatives were not found to be suitable or how alternatives were incorporated into the experimental design. The
Principles of Humane Animal Experimental Techniques, Charles Thomas, Springfield, IL, 1959. They promote a definition of
alternatives as "the three Rs-replacement, reduction, and refinement" which has become a pervasive theme in biomedical
research today.
The American College of Laboratory Animal Medicine Foundation funds grants to study alternative methods of animal use. All
animal users are encouraged to explore this and other means of improving animal welfare while still accomplishing our
research mission.
Replacement
Replacement means replacing 'higher' animals with 'lower' animals. Microorganisms, plants, eggs, reptiles, amphibians, and
invertebrates may be used in some studies to replace warm-blooded animals. [NIH website on Model Organisms for
Biomedical Research] Alternately, live animals may be replaced with non-animal models, such as dummies for an introduction
to dissection for teaching the structure of the animal or the human body, mechanical or computer models, audiovisual aids,
or in vitro modeling. The Animal Care and Use Protocol (ACUP) asks about the alternatives that have been considered, why
they were rejected and how the Principal Investigator searched for these alternatives.
Advantages to replacement include utilizing pre-existing knowledge for teaching, applying known principles to new systems to
look for similarities, and using less expensive animals or models to screen large numbers of agents for toxicity or mutagenicity.
Disadvantages to replacement chiefly stem from the fact that any models are dependent on pre-existing information. In a
system as complex as a live organism, all of the variables in physiology and pathology are not known. Thus, any research on
new biological processes must utilize a living organism at some point.

17. Reduction
It means minimizing the number of animals needed to perform an experiment or teach a concept. This
alternative is addressed in Appendix A, but also in the ACUP form which asks for justification of the
species to be used and the numbers needed for each experimental group. By examining these
parameters, the IACUC can determine if thoughtful experimental design was employed to minimize
overall animal use. Methods to achieve this include:
 Performing pilot studies to determine some of the potential problems in an experiment before
numerous animals are used
 Designing a study to utilize animals as their own controls
 Gathering a maximum amount of information from each animal, perhaps gathering data for more
than one experiment concurrently
 Consulting with a statistician to use only the numbers of animals required to achieve significance
 Minimizing variables such as disease, stress, diet, genetics, etc., that may affect experimental
results
 Performing appropriate literature searches and consulting with colleagues to ensure that
experiments are not duplicated
 Using the appropriate species of animal so that useful data is collected
 Replacement whenever possible.

18. It means refining experimental protocols to minimize pain or distress whenever possible. This concept is addressed in numerous questions
throughout the Animal Care and Use Protocol Form. Examples of refinement include:
Identifying pain and distress and making plans for preventing or relieving it.
Setting the earliest possible endpoint for the experiment. That is, if the necessary information can be gathered before the animal experiences
any ill effects from the experiment, this should be defined as the endpoint and the animal subsequently euthanized. For example, if
measuring toxicity of a compound or survival following implantation of a neoplasm, a pilot study may determine that once certain clinical
signs are seen, or a tumor achieves a certain size, the time course until debilitation or death are predictable. Subsequent experiments may
then utilize the earlier endpoint of tumor size or clinical signs of toxicity, rather than death as the endpoint.
Receiving adequate training prior to performing a procedure.
Using proper handling techniques for animals.
Ensuring that drug doses are correct and that the drugs used are not expired.
Ensuring that procedures to be performed on the animal are reasonable for that species.
Using appropriate anesthetics and analgesics for potentially painful procedures.
Performing surgeries and procedures aseptically to prevent infection.
Performing only a single major survival surgery on any one animal, whenever possible.
Performing appropriate post-surgical care, including thermoregulation and fluid balance.
There are several specific research techniques in common use that are often criticized for their potential for causing pain or distress to
animals. The IACUC has established policies on some of these techniques. These include the use of Freund's Complete Adjuvant for antibody
induction; foot pad injections; blood collection; ascites production for production of monoclonal antibodies; tumor induction; survival
surgery; euthanasia; the use of the lethal dose 50 (LD 50), or other death as an endpoint studies, Animal Care and Use Protocol Form. Beside
the information in the appendices, information on possible alternatives for these procedures is available from RAR.
In some cases, application of one alternative concept may have an adverse effect in another area (i.e using a "lower" animal or minimizing
pain or distress may require using more animals.) These issues are discussed by the IACUC and depending on the circumstances different
priorities may be set.