© Springer International Publishing Switzerland 2016
Alireza Bagheri, Jonathan D. Moreno and Stefano Semplici (eds.)Global Bioethics: The Impact of the UNESCO International Bioethics CommitteeAdvancing Global Bioethics510.1007/978-3-319-22650-7_1212. The UNESCO International Bioethics Committee and the Network of Ethical Advisory Bodies in Europe: An Interactive Relationship
(1)
Medical University of Vienna, Vienna, Austria
Abstract
Since its creation in 1993 the International Bioethics Committee (IBC) has developed important declarations in the field of bioethics shaping the worldwide debate with a focus on goals that are important for all UNESCO Member States. The IBC members are independent experts representing different regions, professions as well as different cultures of the currently 195 UNESCO member states. The UNESCO declarations do not constitute legal sources by themselves and consequently are not legally binding, but exercise an important influence on bioethical debates. However, the more specific the topic and the “newer” the topic in the biomedical research area, the more probable will be its adoption in other international or national documents.
As the bioethical debate in the United States and Europe is historically strong, the influence of the IBC and its documents should be examined in a different way compared to other regions. However, with respect to Europe, one has to distinguish between the various geographical definitions of Europe: the European Union, the Council of Europe and UNESCO. An important influence of the IBC in Europe comes from the activities of European members of the committee in academia and the various national ethical bodies.
12.1 Introduction
The bioethics debate worldwide has been driven by issues of medical research involving human beings. One of the cornerstones in this debate has been the Nuremberg Code (1947) and its requirement for “informed consent” of persons participating in a medical research project (Shuster 1997). Since then, the autonomy of human participants in biomedical research projects has been respected and officially acknowledged. In parallel we have witnessed the development of structured ethical review of medical research. In 1964 the World Medical Association established guidelines governing medical research in the Declaration of Helsinki (2013). Later in 1978 the first amendment of the Declaration introduced “Ethics Committees” -as independent bodies- to review medical research protocols. Thus the ethical review system which today is an integral part of clinical research all over the world was created. Today (Research) Ethics Committees have to be established in institutions where medical research on human beings is conducted to ensure ethical review of clinical research projects. While the name of the committee might differ, for instance, Institutional Review Board , Ethical Review Committee or Independent Research Ethics Committee, its mandate is generally the same: to review research protocols to see whether or not the integrity and wellbeing of patients or healthy volunteer participants are protected. These committees are composed of experts, scientists and lay persons. Physicians, nurses, lawyers, pharmacists, patient representatives and ethicists provide necessary expertise on these committees.
In Europe there are many different laws and “soft laws” governing biomedical research. In the EU, requirements for the conduct of clinical trials are provided by the “Clinical Trials Directive” (2001/20/EG of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use). The EU Directives have to be transformed into national law within the single European Member States (Druml 2009). Further revision of European law for clinical trials has been adopted by regulation which is directly applicable in all EU countries (Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). The regulation entered into force on 16 June 2014 but will apply no earlier than 28 May 2016. This means that the Clinical Trials Directive will still apply until that date.
It should be noted that the function of Research Ethics Committees in Europe is based on the same legal requirements and the success of these committees has paved the way for the establishment of advisory Bioethics Committees in Europe (Huriet 2009). While Research Ethics Committees have the mandate to review specific, clinical research projects on human beings, Bioethics Committees are established at the local, regional or national level. Their mandate is to advise a body such as, a government or a house of parliament, on general ethical questions arising from the advancement of biomedical research. When their mandate is at the national level, they are called “National Bioethics Committee s ”. Furthermore, in general they also have other obligations like fostering public debate and awareness in those issues, and making recommendations for specific laws and regulations. The work of Bioethics Committees is assisted by other similar bodies established within professional organizations, with a focus on advising their organizations on bioethical matters of importance and specific cases within their mandates (UNESCO 2005).
In Europe the French “Conseil Consultatif National d’Ethique” (CCNE) was the first National Bioethics Committee founded (CCNE 1983). In February 1983, after the research summit “Assises de la recherche”, France ’s President François Mitterrand issued a decree creating the first National Consultative Ethics Committee for Health and Life Sciences. Conducting human experiments was one of the first topics to be addressed by the CCNE, along with ethical issues surrounding medically assisted procreation. Many other European States have followed France’s lead by establishing national advisory bodies for bioethical issues. They differ in composition and working method, but are more or less independent. The members are selected because they are considered the experts in influential fields such as law, medicine, natural sciences, philosophy, ethics and political sciences. However, in Europe there are also other non-national advisory bodies, which provide advice and recommendations for regulations on bioethical topics.
12.1.1 European Group on Ethics in Science and Technology
In Europe there is a body specifically established to advise the European Commission. This committee, which has been named “The European Group on Ethics in Science and Technology” (EGE), is also independent, pluralistic and multidisciplinary and was originally established in 2001 by the European Commission (EGE 2001). Its mandate was renewed in December 2009 and the 15 members from European Member States advise on the ethical aspects of science and new technologies with respect to preparation and implementation of legislation and policies. The committee works either on its own initiative or following a request of the European Commission. Parliament and Council are in the position to draw the Commission’s attention to questions which they consider to be of major ethical importance. The Bureau of European Policy Advisers, (BEPA) is the office of the European Commission responsible for bioethics and ethics of science and new technologies and serves as the secretariat of the European Group on Ethics in Sciences and New Technologies (EGE). BEPA is tasked with disseminating the recommendations and decisions of EGE group. What is furthermore important is that BEPA represents the European Commission in meetings on bioethics and ethics of science organized by relevant third parties like UN agencies, the Council of Europe , International Organizations, and nationally and internationally relevant authorities in this field. BEPA also organizes the European Commission’s international dialogue on bioethics, where the EGE, the Chairs of 15 non-EU National Ethics Councils from 5 continents, the Chairs of the EU National Ethics Councils as well as representatives of international organizations meet to share information, discuss the main bioethics topics and create synergies. This is one of the occasions where a representative of the International Bioethics Committee of UNESCO presents its current work to a large expert audience within the European area.
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