Biomedical research involving children is still a debated issue. Since the Nuremberg Code, which made voluntary informed consent of a competent participant a necessary condition of medical research, the general approach in national and international policies and ethical guidelines has changed significantly. A number of different aspects of research with children subjects have been discussed extensively. The first step in changing attitudes towards such research was almost universal acceptance of the conviction that participation in biomedical research not only poses risk, but it can sometimes also be beneficial to participants. The next step was the recognition of the importance of evidence based medicine. The main premises here are that only evidence based medicine can be really and consistently beneficial and that no population should become therapeutically orphaned and left without safe and proven therapies (Ross
2004). Consequently, the involvement of children in biomedical research was justified by two important principles of medical ethics: beneficence and justice. References to these principles can be found in many regulations and guidelines. The
Explanatory Report to the
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine—(Oviedo Convention) explicitly says that banning such research would stop development of science and deprive groups of incompetent people from the benefits of progress in medicine (Council of Europe
1997a). Similar explanation is found in the report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,
Research Involving Children. This report points out that prohibition of participation of children in biomedical research would be unjust, because the fruits of the progress in medicine would be available to adults but not to children (National Commission
1977). In commentary on CIOMS Guideline 14, it is stated that participation of children is a necessary condition for progress in research into diseases and conditions to which children are susceptible (Council for International Organizations of Medical Sciences
2002). The same reason is given by regulations and recommendations that support research with children. Recent regulations in the US and the EU support research involving children by promising substantial incentives for the pharmaceutical industry. In the EU, pharmaceutical companies are obliged to present a
Paediatric Investigational Plan, which is thought to influence research and development of medicinal products for pediatric use (European Commission
2006). These regulations are deemed to stimulate pharmaceutical industry. European agencies are becoming involved in the process of development of new treatments for children. Recently, the European Medicines Agency issued a 5-year Report to the European Commission that shows the results of implemented Pediatric Regulation (European Medicines Agency, Paediatric Committee
2012). Also the European Commission published a report to the European Parliament and the European Council. This is a report on experience acquired as a result of the application of Paediatric Regulation, and it shows that development of pediatric drugs has become one of the important issues of European politics (European Commission
2013). Although there are common regulations within the European Union, there are still important differences between laws of particular member-states. The Clinical Trials Directive does not determine all aspects of research with minors. For instance, it does not provide the definition of ‘minor’. Besides that its scope is limited to the area of clinical trials. Therefore, the Directive does not regulate other kinds of medical and other research involving children (European Parliament, Council of the European Union
2001). Thus, in some EU members’ research, which are not clinical trials, are not regulated by legislation, for instance in Ireland (Sheikh
2008). In others, like in Belgium, all types of research is regulated by the law (Pinxten et al.
2008). Another issue is that some EU members follow solely the Directive. Other EU members either ratified or implemented standards proposed by the Oviedo Convention and its protocols (Gevers
2008). Oviedo Convention is a document issued by the Council of Europe, an organization of all European and some non-European countries that aims at cooperation and promoting democracy and human rights. These two documents, namely the Directive and Oviedo Convention, differ in some important aspects, for instance in risk–benefit ratio and in respecting minor’s dissent. Moreover, the systems of ethical assessment of research widely differ in all states of the EU (Kenter and Cohen
2012). The Directive was deemed to be the cause of the decrease in clinical trials in the EU, and increase in their costs. In 2016 it will be replaced by the new Regulation (European Commission
2012). But the new Regulation will not significantly change the situation of research with minors and incapacitated patients. Also it will not unify the system of ethical assessment. Some even expressed a regret that the Regulation will not unify the system and might even contribute to decrease of its quality (Heringa and Dute
2013; Waligora
2013; Westra et al.
2014).
Empirical research conducted in some European countries shows law in some cases might be flexibly applied. For instance, in the Netherlands promising research without prospect of direct benefit, posing more than minimal risk, was in some cases considered acceptable (Westra et al.
2010). However Dutch law allows non-beneficial research with incompetent subjects only, when it posed negligible risk and minimal burdens (Westra et al.
2010; Kenter
2008). Also in Germany, which seems to be one of the most conservative countries in the EU in regards to non-beneficial research, Research Ethics Committees (RECs) chair-persons significantly vary in their attitudes towards non-therapeutic research (Lenk et al.
2004). Also in the US there are doubts about some aspects involving incompetent subjects in research. There is still discussion on what counts as direct and indirect benefits of research (Friedman et al.
2012; Joffe et al.
2006), what is a proper definition of research (Kass et al.
2013), and what limits of risk could be acceptable in non-beneficial research (Wendler
2013).