Formation of Scientific Knowledge

This module starts with the stages toward the acquisition of scientific
knowledge and ends with responsibilities of scientists to the society. The
module covers the experimentation on animals and humans and its
ethicality, the application of science to technology and of technology to
science, the sociopolitical influence on science and the intellectual property
dispute, biopolicy, conflicts in scientific study, and research data recording.
Read through the text more than once in order to grasp the key details
of the lesson. Then, view the powerpoint presentation while listening to the
recording that refers to the details in the slides.

Biomedical Experimentation with Animals

Sociopolitical Foundation
Biomedical experimentation using animals as subjects has made
breakthroughs in understanding the functions of body organs and in
formulating medicinal drugs for treating various disorders. However, since
1800s, the involvement of animals for the study of anatomy and physiology
of both animals and humans and for the development of therapeutic drugs
has been the subject of criticism of animal rights activists who were then
called antivivisectionists. Still considered as the two most influential animal
rights philosophers are Peter Singer (Princeton faculty member) and Tom
Regan (North Carolina State University emeritus professor). Of much
influence on the ethical and legal foundations of biomedical research using
human subjects were the 10 principles listed in the Nuremberg Code of the
late 1940s. The third principle of the Code validated the use of animals for
biomedical experimentation, whereby the anticipated outcomes of the
biomedical research should justify the experimentation with animals.
Legislation/Regulation
Regardless of the consensus concerning the use or criticism of the use
of animals in biomedical research, the US has undergone a series of
legislation and regulation of animal research, as shown in Table 1.
Table 1. Brief history of US legislation/regulation of animal use in research

1960 Federal legislation requiring individual animal researchers to be

licensed was proposed, owing to the initiatives of Animal Welfare
Institute.

1963 The Guide for the Care and Use of Laboratory Animals (shortened to the
Guide) was published by the US National Institutes of Health (NIH). The
Guide was revised several times from 1965 to 1996.

1966 The Laboratory Animal Welfare Act was enacted, owing to the public
clamor over an article in Life magazine. The legislation underwent a

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 series of amendments from 1970 to 1985, and is presently termed as the
Animal Welfare Act (AWA).

1985 NIH was required, through the Health Research Extension Act of 1985,
to establish guidelines concerning the use of animals in both biomedical
and behavioral research.

1986 The NIH Office of Protection from Research Risks published the Public
Health Service (PHS) policy on the Humane Care and Use of Laboratory
Animals, whereby PHS laboratories (as well any other institution that
would request for funding from PHS) must abide by the PHS policy and
the Guide.

2010 The US National Academy of Sciences published the 8th edition of the
Guide. Such publication signaled the wide acceptance of the Guide by the
US and international animal research institutions.

The Guide for the Care and Use of Laboratory Animals (shortened to the
Guide) serves as a significant document for both the scientific community
and animal care personnel because of the following reasons:
(1) The Guide provides guidelines concerning the way in which animal
research should be done, including recommendations for overseeing the
welfare of animals, including veterinary care and management of facilities
for housing and environment.
(2) The Guide mandates numerous institutional policies that animal
researchers should follow as to the screening and training of the
professional animal care personnel and as to the protection of the staff
who come into contact with the animal subjects.
(3) The Guide addresses the appropriateness of the physical environment
where the experimental animals stay, including ventilation and
temperature conditions, as well as the actual place where animals are
experimented upon.
The Guide requires each research institution to have an Institutional
Animal Care and Use Committee (IACUC) having a minimum of three
members, who are responsible for the welfare of animals used in research
and who should evaluate the living conditions of the animals and the
research protocols for approval. One of the members of the committee must
be a doctor of veterinary medicine (DVM) who should oversee all aspects of
animal care, one practicing scientist, and at least one non-affiliated
personnel.
The AWA obliges each research institution to have an Institutional Animal
Care and Use Committee (IACUC) having a minimum of three members. The
members must include one DVM and at least one non-affiliated personnel.
 The PHS policy mandates an IACUC that has a minimum of five members.
The members must include one DVM, one practicing scientist, one non-
scientist, and at least one non-affiliated personnel.
Ethical Guidelines
As proposed by William Russell and Rex Burch in 1959, animal research
institutions should conform to the three principles (3 R’s) concerning the
human use of animals for biomedical experimentation. These principles are:
(1) Replacement – refers to the use of lower species of animals as much as
possible, as lower species are viewed as less susceptible to pain and
distress as compared to higher species of animals, including chimpanzees.
(2) Reduction – refers to the reduction of the number of animals to be used
for experimentation as much as possible.
(3) Refinement – refers to the minimization of frequency or degree of pain
and distress that animal subjects experience in experiments.
Animal Rights Movement
One of the staunch defenders of animal welfare is the People for the
Ethical Treatment of Animals (PETA). Although numerous animal rights
activists fight for animal rights appear to be sincere in their advocacy, some
of them have resorted to violence to discourage the scientific commu nity
from using animals as experimental subjects. In this regard, the US enacted in
2006 the Animal Enterprise Terrorism Act to protect researchers from acts
of violence perpetrated by groups of anti-animal research militants.

Biomedical Experimentation with Humans

Sociopolitical Foundation
The 10 Nuremberg Principles (Nuremberg Code) served as the ethical
and legal foundation for the future guidelines concerning the use of human
subjects for biomedical research, of which the most notable is the Declaration
of Helsinki. The statements in the Code upheld the protection of human
subjects, the analysis of the risk as contrasted to the benefit of the
experiments, the performance of experiments only by scientists, the right of
the human subject to withdraw from the experiment anytime they wish to,
and the initiative of the researchers to halt the experimentation for
anticipated injury, disability or death of the human subject in the course of
the experiment. The Code actually stemmed from the trials in Nuremberg
concerning crimes committed in World War II. The trials prosecuted all those
involved in experimentation on humans without the willingness or
permission of the human subjects.
International Regulation
The Declaration of Helsinki was formalized in 1964 by the World
Medical Association (WMA) in Helsinki, Finland. Containing guidelines
concerning the humane use of humans in biomedical research, such
document has become the international standard for biomedical

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 experimentation with humans. Since then, the document underwent a series
of amendments until 2013.
American Initiative
In relation to the Declaration of Helsinki, the US PHS issued a memo
two years after the Helsinki Conference, specifying the first requisite to the
institutional review boards (IRBs). Such memo required that research
studies that are to be funded by PHS be subjected to independent review to
examine the rights and welfare of study participants, the accuracy of
processing the informed consent, and the possible benefits and risks of the
biomedical research to be conducted.
In 1979, the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research presented the Belmont
Report, which contains three basic ethical considerations in using h umans as
subjects for research. Generally accepted by IRBs, the three principles are:
(1) Respect for Persons – requires that the research subjects to be capable of
making their own decisions.
(2) Beneficence – requires that the risk to human subjects be minimized and
that the benefits of conducting the research be maximized.
(3) Justice – requires that the burden on human subjects be equally
distributed and not merely concentrated on an individual or a single
group of individuals.

Glossary
Anatomy – parts of the animal or human body; plant structure
(http://www.macmillandictionary.com/us/dictionary/american/anatomy).
Physiology – the study of the functioning or operation of bodily parts of living
things
(http://www.macmillandictionary.com/us/dictionary/american/physiology
).
Biomedical – pertaining to biomedicine.
Biomedicine – the application of the principles of biology/biochemistry to
the field of medicine
(http://www.macmillandictionary.com/us/dictionary/american/biomedicin
e).

References
Lecture Reference:
Macrina, F. (2014). Scientific Integrity: Text and Cases in Responsible Conduct
of Research (4th ed.). Washington, DC: ASM Press.
Reading Activity Reference:
 Norrgard, K. (2008). Human Subjects and Diagnostic Genetic Testing. Nature
Education. Retrieved from http://www.nature.com/scitable/topicpage/human-
subjects-and-diagnostic-genetic-testing-720

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