| Abstract |
In recent decades, the development in biomedicine and biotechnology helped prolong the life expectancy of many children around the world due to the significant development of vaccines, thus preventing or even reducing the incidences of childhood diseases, where up until the development of those vaccines, those diseases were responsible for causing childhood fatalities and disabilities. The creation of vaccines such as polio, measles and more, reduced dramatically the number of cases of such infections. The need for protecting the rights of children raised questions about how capable is a center to support such researches, and at the same time, a public commitment was given to establish legal frameworks for the expansion and the proper functioning of pediatric clinical studies. Through the global promotion of vaccination necessity, it became possible to define even more specific objectives for vaccination programs. In turn, those objectives rose the fundamental need for a first separation between children and adults, but also the need to establish the definition of the term ―child‖. The separation between children and adults and the age groups that children belong to (according to their cognitive characteristics), as well as the definition of the lawful age for the participation of those subjects (children) in decisions affecting their own health, are the most important parametersset by the FDA and the EMA, thus providing the basis for the regulatory framework for research in children. The realization that an infant cannot be in the same study group with a teenager, mainly because of the significant differences in both a psychological and a physical level was of imperative importance. The ability to make decisions by the same child (or his caregiver)was also determined mentally by that age segregation.
―The vaccination of Edward Jenner‖, is the first documented pediatric study in the history of pediatrics. After that, numerous large-scale experiments followed, which were
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handled incorrectly - especially during the Second World War - thus, rising a utilitarian need for the delimitation of such clinical studies. The Nuremberg Code is the preamble to that delimitation. The first steps for the initiation of pediatric studies, began in Greece in 1835. After several chain reactions in the research fields, but mainly after the need for the protection of children especially due to moral misconduct, the surveys limits became clearer and researchers were now forced to ensure their positions before taking up any study. The order and the way in which most data processing was collected was clearly defined, along with the proper process for approval of the marketing of any vaccine on the market. The separation of the three phases in drug data processing is a basic stage in which every vaccine should be tested, analyzed, and then judged according to its suitability. Apart from all of the above, it should be noted that there are two opposing sides regarding vaccination in general, in which one group are supporters of vaccination and the other are opponents, whose conflicting views result in several bioethical dilemmas that require resolution. Ethical implications arise from both sides, and it is in this case that the National Ethics Commission intervenes, emphasizing in turn the importance of information given both to patients and caregivers, as well as the necessity of vaccination, confirming in this way its value as well as emphasizing it. The universal recognition of all the above was achieved with the adoption of legal and institutional texts for everyone. Children’sbasic need for protection and the respect for theirdignity were the cornerstones under which all ethical issues involving children were materialized. In 1978, the Belmont Report presented coherently and collectively the basic ethical principles of biomedical research. The principle of beneficence,the principle of respect for another human being, and finally, the principle of justice, are the principles under which each study should be outlined, and the principles under which the body of ethical analysis of research on human subjects should be determined.
The protection of vulnerable populations, the doctor-patient cooperation, as well as the guidance, preparation and implementation of clinical trials are just some of the elements that emerged after the drafting of the Belmont Report. Self-determination,
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autonomy, and respect for the individual, are just a few features of the principles presented in this report, that belong to the principle of respect for another human being. Providingthe maximum benefitto individuals, as well as minimizing the risk of damage to another person, and mainly respecting all individuals, are features of the principle of beneficence. Finally,the fair and equal treatment and provision of distributive justice characterize the principle of justice. Generally, in pediatric ethics, those principles run contrary to the research conducted in adults, giving more importance on the wellbeing of a child than on its autonomy, but also the concept of a child’s "best interest‖ can have a different semantic meaning, since it can often can be considered pliable according to the child’s needs and special social/environmental/economic factors surrounding it. In addition to all ethical principles above, legislativeand institutional regulations have been adopted, relating to pediatric patients in order to ensure a consistent quality in clinical research. Equal rights, a child’s inherent dignity and the foundations of freedom and justice are just some of the elements that have solidified through such regulations. The Declaration of the Rights of the Child by UNICEF, the Directive 2001/20 / EC, the Oviedo Convention and the Regulation No. 536/2014 of the European Parliament, consist the regulatory framework in Greece when it comes to research concerning children. The interconnectedness and the complementarity of those elements, cover all the parameters that might surface.
Children are by definition objectively unable to defend their interests, therefore, societies - but also those involved in a clinical trial - are required to protect and defend their rights, both within the legal framework and within the ethical framework governing biomedical research. The scientific necessity helped so that children do not undergo clinical trials unnecessarily. Their sensitivity in all areas of their lives makes them a vulnerable part of the population as well as easily exploitable. On the contrary, children have every right to choose for themselves the treatment that they wish to have administered to them, and have the perfectly legitimate right to have that said desire respected by all other stakeholders. It should be made absolutely clear, that the ethical
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issues regarding pediatric research are very important and that they need to be understood and not suppressed or ignored.
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Κλινικές μελέτες εμβολίων στα παιδιά : βιοηθικοί προβληματισμοί και ρυθμιστικό πλαίσιο στην Ελλάδα
