Nuremberg Code

Should the Great Australian Party win a seat in parliament, we would attempt to pass a bill making the Nuremberg Code law in Australia.

The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to which physicians must conform when carrying out experiments on human subjects in a new code that is now accepted worldwide.

This judgment established a new standard of ethical medical behaviour for the post World War II human rights era. Amongst other requirements, this document enunciates the requirement of voluntary informed consent of the human subject. The principle of voluntary informed consent protects the right of the individual to control his [or her] own body.

This code also recognises that the risk must be weighed against the expected benefit, and that unnecessary pain and suffering must be avoided.

This code recognises that doctors should avoid actions that injure human patients.

The principles established by this code for medical practice now have been extended into general codes of medical ethics.

The Nuremberg Code (1947)

[from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington, D.C.: U.S. G.P.O, 1949–1953.]

Permissible Medical Experiments

The great weight of the evidence before us is to the effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts:

1. 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 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 reasonably 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.

2. 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.

3. 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.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6. 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.

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. 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.

9. 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.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probably 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.

In addition to the Nuremberg Code, we are adopting a slightly modified version of the ‘valid consent’ section found within the ‘Australian Immunisation Handbook’ as follows:

Informed medical consent to include all vaccines

Valid consent is the voluntary agreement by an individual to a proposed procedure, which is given after sufficient, appropriate and reliable information about the procedure, including the potential risks and benefits, has been conveyed to that individual.

As part of the consent procedure, people receiving vaccines and/or their parents or carers should be given sufficient information (preferably written) about the risks and benefits of each vaccine. This includes:

* what adverse events are possible

* how common they are

* what they should do about them

Criteria for valid consent

For consent to be legally valid, the following elements must be present:

1. It must be given by a person with legal capacity, and of sufficient intellectual capacity to understand the implications of receiving a vaccine.

2. It must be given voluntarily in the absence of undue pressure, coercion or manipulation.

3. It must cover the specific procedure that is to be performed.

4. It can only be given after the potential risks and benefits of the relevant vaccine, the risks of not having it, and any alternative options have been explained to the person.

The person must have the opportunity to seek more details or explanations about the vaccine or its administration.

The information must be provided in a language or by other means that the person can understand. Where appropriate, involve an interpreter or cultural support person.

Obtain consent before each vaccination, after establishing that there are no medical condition(s) that contraindicate vaccination. Consent can be verbal or written.

Consent on behalf of a child or an adolescent

A parent or legal guardian of a child has the authority to consent to that child being vaccinated.

For certain procedures, including vaccination, a child or adolescent may be determined to be mature enough to understand the proposed procedure, and the risks and benefits associated with it. These young people may have the capacity to consent under certain circumstances.

If a child or adolescent refuses a vaccination that a parent or guardian has given consent for, respect the child’s or adolescent’s wishes, and inform the parent or guardian.

Consent on behalf of an adult lacking capacity

Carefully assess an adult’s capacity to give valid consent to vaccination. If the adult lacks capacity, obtain consent from a legal substitute decision-maker. For example, this may occur for influenza vaccination of an elderly person with dementia.

Communicate the risks and benefits of vaccines

Use plain language when communicating information about vaccines and their use. The person to be vaccinated (or their parent or guardian) must:

* be encouraged to ask for more details

* have enough time to decide whether to consent

Provide printed information to supplement any verbal explanations.

Evidence of consent

General practice or public vaccine clinics

People can give consent either in writing or verbally, according to the protocols of the health facility. All consent must meet the criteria for valid consent.

Document evidence of verbal consent in the clinical records.

For electronic medical records, include a typed record of verbal consent in the person’s file, or scan a copy of written consent into the file.

If the practice or clinic routinely follows a standard procedure, show that the provider followed the procedure by using a stamp, a sticker or the provider’s signature.

People need to give explicit verbal consent before receiving any vaccine, even if they gave written consent at previous vaccination encounters for the same vaccine. Document verbal consent in the person’s file each time they give it.

School-based vaccination programs

Consent is required to provide individual vaccines or a vaccine course through school-based vaccination programs.

In school-based, and other large-scale, vaccination programs, the parent or guardian usually does not attend with the child on the day they receive the vaccine. Written consent must be obtained from the parent or guardian in these circumstances.