"Trangenesis'

15. The use of organs from engineered animals for xenotransplantation raises the need for certain reflections on transgenesis and its ethical implications.

The term "transgenic animal" is used to indicate an animal whose genetic make-up has been modified by the introduction of a new gene (or genes). In contrast, the term "knock out" is used to designate those animals in which a given endogenous gene (or genes) is no longer expressed. In either case, such animals will express particular characteristics which will be transmitted to the offspring.

As we have already observed, the possibility of working out such genetic modifications, using genes of human origin as well, is morally acceptable when done in respect for the animal and for biodiversity, and with a view to bringing significant benefits to man himself. Therefore, while recognizing that transgenesis does not compromise the overall genetic identity of the mutated animal or its species, and reaffirming man's responsibility towards the created order and towards the pursuit of improving health by means of certain types of genetic manipulation, we will now enumerate some fundamental ethical conditions which must be respected: 

1. Concern for the well-being of genetically modified animals should be guaranteed so that the effect of the transgene's expression, possible modification of the anatomical, physiological and/or behavioural aspects of the animal may be assessed, all the while limiting the levels of stress and pain, suffering and anxiety experienced by the animal;

2. The effects on the offspring and possible repercussions for the environment should be considered;

3. Such animals should be kept under tight control and should not be released into the general environment;

4. The number of animals used in experiments should be kept to a bare minimum;

5. The removal of organs and/or tissues must take place during a single surgical operation;

6. Every experimental protocol on animals must be evaluated by a competent ethics committee.
Informed Consent