Ethics in Biomedical Research

Question 1

Autonomy

Answer 1

The principle of respect for the person and their ability to make decisions for
themselves. This principle underlies the concept of informed consent.

Question 2

Beneficence and non-maleficence?

Answer 2

The principle that you must do good and what is in the participants interests is
termed “beneficence”. The principle of avoiding unnecessary harm is termed
“non-maleficence”.

Question 3

Justice?

Answer 3

It is the fair adjudication between competing claims. As such, it is linked to
fairness, entitlement and equality. In health care ethics, this can be subdivided
into three categories: fair distribution of scarce resources, respect for people’s
rights, and respect for morally acceptable laws.1

Question 4

Ten research ethic principles?

Answer 4

Check notes

Question 5

What are the core principles of research

Answer 5

Autonomy
Beneficence
Non-maleficence
Justice

Question 6

Common Types of animal research ?

Answer 6

1. Basic Science:
   provide information on biological systems and their functioning. Such studies range from simple observational and behavioural studies, to studies of
   animal physiology or genetics. The impact on animal welfare ranges from no impact
   (e.g., observational studies of animals in their natural environment) to serious impact
   (e.g., experimentally changing the normal functioning of animals).
2. Animal models of human disease:
   Animal models of disease (including genetically modified animals) provide information
   on the pathogenesis of human diseases and identification of therapeutic targets. The
   effect of such studies on animal welfare are typically severe, and usually animals are
   killed at humane endpoints. It is acknowledged that animal models do not fully
   replicate the human disease state.

Question 7

Normative theory?

Answer 7

Normative theory seeks to develop theoretical frameworks that can help to determine
whether actions are right or wrong. There are two main ethical frameworks with regards to
experimentation involving non-human animals. These are:

Question 8

Consequentialism

Answer 8

Seeks to weigh-up consequences. For example, the values of the research goals, the
degree of harm to the animals, and the availability of alternatives to animal use. The
framework requires two steps, namely, the identification of benefits and harms, and a
decision on whether the benefits outweigh the harms. One of the foremost
consequentialist positions is utilitarianism, which taken at its extreme means that if
intervention causes more benefit (pleasure) than harm (pain), then the ends justify the
means.

Question 9

Deontology

Answer 9

Adheres to the principle that doing right is better than doing good. Deontology takes
no account of the outcome of an action, so experimenting on animals is not right, even if the benefit of such actions achieves a greater good (e.g., a new treatment for a
disease)

Question 10

Core principles of animal experimentation?

Answer 10

1. Rationale
   Procedures involving animals should be designed and performed with due
   consideration of their relevance to human or animal health, the advancement of
   knowledge, or the good of society.
2. Justification
   The animals selected for a procedure should be of an appropriate species and quality
   and the minimum number required to obtain valid results.
3. Minimize pain and distress
   Proper use of animals, including the avoidance or minimization of discomfort, distress,
   and pain when consistent with sound scientific practices, is imperative.
4. HUmane Endpoints
   Animals that would otherwise suffer severe or chronic pain or distress that cannot be
   relieved should be painlessly killed at the end of the procedure or, if appropriate,
   during the procedure
5. Training
   nvestigators and other personnel shall be appropriately qualified and experienced for
   conducting procedures on living animals.

Question 11

The three “R”

Answer 11

Replacement
Use methods that avoid or replace the use of animals. Replacement includes full
replacement, where the use of animals is completely avoided (e.g., computer models,
cell cultures). Partial replacement refers to the use of animals, but animals that are hought incapable of experiencing suffering (e.g., Drosophila, nematode worms,
amoebae).

Reduce
Reduce the number of animals required to the bare minimum to obtain scientifically
valid results. The reduction includes the use of data collection methods that allow
sequential measurements on the same animals, rather than sequential killing of
batches of animals at each time-point.

Refine
Refine the methods and processes used for research, housing and husbandry to
alleviate the amount of suffering an animal experiences. Examples of refinement
include ensuring the animals are provided with housing that allows the expression of
species-specific behaviours, using appropriate anaesthesia and analgesia to minimise
pain, and training animals to cooperate with procedures to minimise any distress.

Question 12

What are examples of animal replace therapy?

Answer 12

1. Computer Models
2. Cell Cultures
3. Use animals that are incapable of suffering: e.g., Drosophila, nematode worms,
   amoebae).