Biomedical research involving non-human animals

Question 1

Give 5 examples of organisations that use animals in biomedical research?

Answer 1

Universities
Medical schools
Charities
Governmental bodies eg. NHS
Commercial organisations

Question 2

Give 5 reasons why animals are used in research?

Answer 2

Creating and breeding of genetically modified animals

basic research

regulatory testing of products

protection of natural environment

preservation of animal species

Question 3

How has animal use in research allowed protection of the natural environment in 4 ways?

Answer 3

allowed ability to transfer embryos, eliminate parasitism, treat illnesses, and use anaesthetic advances

Allowed survival of many species

Question 4

What are the 2 moral arguments that promote animal use in research?

Answer 4

Necessity argument

Comparable moral value argument

Question 5

Describe the necessity argument of animal use in research?

Answer 5

In-vitro or in-silico investigations cannot replicate the function of complex living systems

Question 6

Describe the comparable moral value argument of animal use in research?

Answer 6

Human wellbeing is paramount and it is even less morally acceptable to experiment on humans

Question 7

Give 2 reasons why animal subjects are preferred to human subjects?

Answer 7

Human subject use involves risk of economic coercion: Only vulnerable socioeconomic groups will be selected for research in exchange for financial gain

Many people regard humans as having more moral worth than animals

Question 8

What is meant by human subjects having the risk of economic coercion?

Answer 8

Only vulnerable socioeconomic groups will be selected for research in exchange for financial gain

Question 9

Which directive of the European parliament has legislation on animal rights in research, and which boards see that this legislation is followed?

Answer 9

Directive 2010/63/EU

overseen in research by Animal Welfare Ethical Review Boards (AWERBS)

Question 10

What are the 3 main rules in article 4 of the 2010/63/EU directive to protect animal rights?

Answer 10

The 3 Rs: Replacement, reduction, refinement

Question 11

What is meant by the replacement rule in article 4 of the 2010/63/EU directive for animal rights, that member states must follow?

Answer 11

wherever possible, a scientifically satisfactory method/testing strategy, not entailing the use of live animals, shall be used instead of a procedure.

Question 12

What is meant by the reduction rule in article 4 of the 2010/63/EU directive for animal rights, that member states must follow?

Answer 12

number of animals used in projects is reduced to a minimum without compromising the objectives of the project.

Question 13

What is meant by the refinement rule in article 4 of the 2010/63/EU directive for animal rights, that member states must follow?

Answer 13

refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals.

Question 14

Give 2 reasons why animal subjects aren’t preferred to human subjects in research, in terms of discovering potential/new research?

Answer 14

Potential resulting research might not be that important

There is always risk that no new/useful research will be discovered

Question 15

What is meant by possible benefit vs certain harm, when considering why animal subjects aren’t preferrable to human subjects in research?

Answer 15

Can’t ever be certain of the likelihood of possible benefits that will arise from research

Question 16

What was discovered by Archibald and Coleman 2012 about efficacy of drugs tested in animals compared to humans?

Answer 16

92% of drugs shown safe and effective in animals fail in human trials

Question 17

What is meant by Act certainty vs omission possibility, when considering why animal subjects aren’t preferrable to human subjects in research?

Answer 17

animals will surely suffer by the act, humans might suffer without the research

Question 18

What was the argument of The Principles of Morals and Legislation 1789 by Jeremy Bentham, in supporting animal rights in research?

Answer 18

‘The question is not can they reason? Nor can they talk? But, can they suffer?’

Species membership is morally irrelevant, and that anyone who can suffer morally matters for their own sake

Question 19

What was the argument of Peter Singer 1975, in supporting animal rights in research?

Answer 19

‘The capacity for suffering and enjoyment is a prerequisite (required prior condition) for having interests at all’

Capacity to suffer shared by both humans and animals, so they both have equal interests (other activities that have value) and therefore should have equal moral consideration

Question 20

What was the argument of Deontology in supporting animal rights in research?

Answer 20

Never use someone as a means to an end, could argue that animal subject is ‘someone’

Question 21

What was the argument of The case of animal rights by Tom Regan 1983, in supporting animal rights in research?

Answer 21

Animals do have rights because they are ‘‘subjects of a life,’’ just like humans, and those lives have value, whether humans recognize that value or not

Question 22

Describe the research that was done in the Tuskegee Syphilis experiment (1932-1972)?

Answer 22

In the US, 399 African-American men with untreated syphilis were monitored

Question 23

Why was the use of the human subjects in the Tuskegee Syphilis experiment (1932-1972) unethical?

Answer 23

Men were told by researchers that they would be receiving free medical treatment but in reality they were given placebos (didn’t give informed consent).

Therefore the men developed severe complications such as blindness, paralysis, death

Question 24

Describe the research that was done with the HeLa cell line (1952-onwards)?

Answer 24

Henrietta Lacks’ cancer cells were grown in culture and became the first human cell line that could grow and divide endlessly in a lab (immortal).

HeLa cells still in use today to study the effects of toxins, drugs, hormones and viruses on the growth of cancer cells without human subject

Question 25

Give 2 reasons why the use of the HeLa immortal cell line is unethical?

Answer 25

Consent was never gained from her or her family to use her cancer cells

Releasing the genome of her cells to general and scientific community exposed confidential familial genetic info

Question 26

Give 2 reasons why the WWII Nazi prisoner experiments (1942-1945) were unethical?

Answer 26

Denied prisoners of their humanity

Nazis were indifferent to their suffering caused by medical experiments eg. blood coagulation experiments, twin experiment

Question 27

What is the Nuremburg code 1947?

Answer 27

Set of ethical research principles for human experimentation that was drafted by court in a Nuremberg trial after WWII

Question 28

What is the 1st point of the Nuremburg code 1947, and how many points are there in total?

Answer 28

1st point (out of 10) is that voluntary consent is absolutely essential

Question 29

What other set of medical ethical principles were modelled by Nuremburg code 1947?

Answer 29

Four pillars of medical ethics

Question 30

Is the Nuremburg code 1947 part of the jurisdiction of any nation?

Answer 30

Not been officially accepted as law by any nation or as official ethics guidelines by any association

Question 31

What is the Declaration of Helsinki?

Answer 31

Set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA)

Question 32

What is the main difference between Nuremburg code and Declaration of Helsinki?

Answer 32

Nuremberg Code focuses on the human rights of research subjects

Declaration of Helsinki focuses on the obligations of physician-investigators to research subjects

Question 33

What are now the 5 general rules of ethical human research?

Answer 33

Obtain informed consent

Minimise risk of harm to participants

Protect anonymity and confidentiality

Be transparent to subjects (avoid deception)

Respect participants’ right to withdraw