Post World War II saw the beginning of the development of generalised ethical code. These codes, while not event specific, are all in some way a reaction to the events discussed earlier.
Nuremburg
The first international statement on medical or research ethics is drawn from the Nuremburg code. This code originated from the trials held for 32 Nazi Doctors at Nuremberg after World War II. The trial was precipitated by the human experimentation that these doctors carried out during World War II [97]. It is not the first code of medical ethics to stand alone offering guidance, but it was first international code or guideline related to research
concerning humans. The code itself comprised ten principles, which were contained in the final judgment of the court in Nuremberg in 1947. The ten principles expressed the
acceptable limits with regards to human medical experimentation [97]. These principles can be summarized up as follows:-
1. The voluntary consent of the human subject is absolutely essential.
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 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.
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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 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 [25]. These principles were developed in the context of the trial of the Nazi doctors. They are not a mandated set of principles for research and experimentation upon humans but are part of the judgements in the Nazi Doctors Trial [97]. Annas et al [102] expressed the opinion that the Nuremberg code embodies in many ways, all previous ethical codes governing
biomedical research. It highlighted the principles of justice, beneficence, non-maleficence, veracity and confidentiality. It is, however, still only one document, even though its
influence on biomedical research is obvious by its use as the basis for many research codes. Within the concept of the Thomasma ethical tree, these principles relate to both applied and clinical ethics.
Post Nuremburg
There is evidence that around the time of the Nuremburg trials, both the United Kingdom and France made submissions to the Drafting Commission for International Human Rights. Both of these submissions suggested that it should be unlawful to subject any person to medical or scientific experimentation against their will [102]. These submissions became incorporated into Article V on the International Convention of Humans, the first international document derived from the Nuremburg code [102]. Article V was specifically included to dissuade any return of the abuse and atrocities committed in Germany during the war [102]. It stated that: ―No one shall be subjects to torture or to cruel, inhuman or degrading treatment or
punishment.‖ While Article V does not specifically mention medical or research ethics, it provides a basis for development of more specialised statements. It is, however, not necessarily the first published international document which refers to medical ethics [211].
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World Medical Association (WMA)
The WMA was established in 1947 by a group of physicians as a response to the events in World War II [212]. The first document the WMA published, and one of the first documents specifically dealing with medical ethics, was the Declaration of Geneva in 1949. This
modern take on the Hippocratic Oath was originally encompassed in an article entitled ―War Crimes and Medicine: The German betrayal and a restatement of the ethics of medicine‖ in the World Medical Association Bulletin [213]. A year after this, the WMA published their own ―international code of ethics‖ – primarily focused on the duty of the doctor but once again drawing inspiration from the Nuremburg code in its assertions that ―a physician shall act only in the patient‘s interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.‖ [214]
Both the Declaration of Geneva and the International Code of Medical Ethics have been revised since their first appearance. The intent behind them both remains the same. While not explicitly mentioning research carried out on humans, the implication is one of ―First, Do No Harm‖. It was not until 1954, however, that the WMA published their ―Principles for Those in Research and Experimentation‖ – the first explicit mention of doing no harm from a body with worldwide membership. It was written to help researchers clarify their moral obligations in relation to research, and was a document written by doctors for doctors – unlike the Nuremburg Code which was written by jurist in a trial judgement [102]. These principles also helped separate out the different types of research: Research that was in new diagnostic and/or therapeutic methods and research which was undertaken to serve a different purpose than to simply cure an individual. It is this second type of research that is the focus of this thesis.
The last code that the WMA drafted was the Declaration of Helsinki in 1964 [114, 215, 216]. It augments the Declaration of Geneva and the International Code of Medical Ethics by explicitly stating the principles involved in undertaking research on human subjects. Signatories to the original code include the major medical associations of Australia, the United States of America, and the United Kingdom, as well as most of Europe. It also extended the scope of the codes to include biomedical research, something neither of the previous codes did. Although it has been revised or clarified eight times since 1964 (the latest being in 2008), it still does not have the legal standing that one may desire from a document that purports to have international significance: it is non-binding and intended only
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as guidance. The WMA has also published a medical ethics manual which articulates the principles of ethical medical practice and how physicians should interact with the patients, their colleagues and society. It also briefly touches on medical ethics in research, and the function and roles of ethics committees. This document is intended as a training document for new physicians, and for those who wish to extend their understanding of ethics [217]. Both the Declaration of Geneva and the International Code of Medical Ethics have been revised since their first appearance, but the intent behind them remains the same.
World Health Organisation (WHO) and Council for International Organisations of Medical Sciences (CIOMS)
A document which does articulate clearly the needs for ethics in research, although now not as specific as it originally was with regards to large scale studies, is the World Health
Organisation (WHO)/ Council for International Organisations of Medical Sciences (CIOMS) guidelines. These guidelines were originally published in 1991 and were the first
international guidelines specifically aimed at epidemiologists and the types of studies they were likely to carry out. These are still the only international guideline directly targeted at epidemiologists. CIOMS has also published the International Ethical Guidelines for Biomedical Research Involving Human Subjects in 1993.
The WHO/CIOMS guidelines for epidemiologists were first put up for review in 2003, and it was initially thought that the 1991 document could be revised. However, it was found through responses to surveys that many researchers found it difficult to reconcile the 1991 document with the 2002 International Ethical Guidelines for Biomedical research from CIOMS. It was decided that a supplement to the 2002 guidelines concentrating on Epidemiological studies would be written, as opposed to the 1991 guidelines being revised [218].
When the draft proposal for the revised guidelines was published in 2006, it was well-
received by the larger scientific community, but epidemiologists were not supportive. It was suggested that the draft guidelines did not fully take into account the fact that ―the
supplement would not provoke ethics review committees that principally review biomedical research to sufficiently adjust their expectations –and also their membership – to take account of important differences raised by epidemiological studies‖ (emphasis mine). These differences will be seen during the investigation of the case studies, which will be presented later. This thesis attempts to propose a solution to this problem which is certain to
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become even more common as public health studies in Australia and beyond become more prevalent [219, 220].