- The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him/her to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
- The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
- The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
- The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
- No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
- The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
- Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
- The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
- During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
- During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject
General principles for using animals in scientific activities (the Code; NHMRC 2004), by promoting the well being of animals used for scientific purposes.To meet the requirements of the Code, scientists, animal carers and members of AECs mustensure that the use of animals in scientific activities is justified, and that there are no alternativesto using animals
• promoting animal well being
• minimising pain and distress (including recognising and assessing evidence that an animal
is experiencing distress and determining whether this is associated with pain)
• developing strategies to effectively manage pain and distress and to promote animal
• Replacement—If a viable alternative method exists that would partly or wholly replace the
use of animals in a project, the Code requires investigators to use that alternative. E
• Reduction—A project must be designed to use no more than the minimum number of
animals necessary to ensure scientific and statistical validity. However, the principle of
reducing the number of animals used should not be implemented at the expense of greater
pain and distress for individual animals.
• Refinement—Studies must be designed to avoid or minimise both pain and distress in
animals, consistent with the scientific objective. Investigators must also be competent in the
procedures they perform. Project design must take into account
– the choice of animals, their housing, management and care and their acclimatisation
– the choice of techniques and procedures
– the appropriate use of sedatives, tranquilizers, analgesics and anaesthetics
– the choice of appropriate measures for assessing pain and distress
– the establishment of early intervention points and humane endpoints
– adequate monitoring of the animals
– appropriate use of pilot studies.
Other key principles in addition to the 3Rs include Justification and Responsibility:
• Justification—The Code requires projects using animals to be performed only after they
are justified, weighing the predicted scientific or educational value of the project against
the potential effects on the well being of the animals.
• Responsibility—The Code states that investigators who use animals for scientific purposes
have personal responsibility for all matters relating to the well being of the animals. To meet these responsibilities, it is essential that
investigators are knowledgeable about all factors associated with the project that may affect
the the animals they use, mechanisms to minimise these effects, the monitoring
and assessment of adverse effects on the animal , and appropriate actions to take if
adverse effects are observed.