The National Bioethics Committees and the Universal Declaration on Bioethics and Human Rights: Their Potential and Optimal Functioning




© 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_11


11. The National Bioethics Committees and the Universal Declaration on Bioethics and Human Rights: Their Potential and Optimal Functioning



Jean F. Martin1, 2  


(1)
Canton of Vaud Public Health Service, Lausanne, Switzerland

(2)
Swiss Public Health Association, La Ruelle 6, CH-1026 Echandens, Switzerland

 



 

Jean F. Martin



Abstract

The Article 19 of the Universal Declaration on Bioethics and Human Rights calls for the establishment of ethics committees at various levels. There are different types of ethics committees and it is important to distinguish their missions as well as their compositions and operations: National Bioethics Committees, Clinical Ethics Committees, Research Ethics Committees, and Ethics Committees of professional healthcare associations.

This chapter deals with National Bioethics Committees (NBCs). After recalling their emergence over the last decades and the reasons for that movement encouraged today worldwide by the UNESCO Ethics Program – it presents the ways in which they promote the UDBHR and its principles, and try to implement it in practice. Based on the experience of such committees (in Switzerland in particular), the chapter elaborates on the conditions and rules necessary for NBCs to comply with the requirements of independence, multidisciplinarity and pluralism posed by Article 19 of the Declaration.



11.1 Introduction


The Universal Declaration on Bioethics and Human Right s (UDBHR) adopted by the UNESCO General Conference in October 2005, calls for the establishment of ethics committees at various levels, especially at the national level. Article 19 states that, “Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to:

(a)

assess the relevant ethical, legal, scientific and social issues related to research projects involving human beings;

 

(b)

provide advice on ethical problems in clinical settings;

 

(c)

assess scientific and technological developments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of this Declaration;

 

(d)

foster debate, education and public awareness of, and engagement in, bioethics”.

 

Since the adoption of the Declaration, assistance to countries in establishing National Bioethics Committee s (NBCs) and training their members has been a major part of the work of the UNESCO. In the following statements issued on the occasion of 20 years of activities of its International Bioethics Committee (IBC), UNESCO elaborates its position in this regard, “… The convergence of technologies is opening new ethical, social and legal challenges for both developing and developed countries. Responsible scientific and technological innovation makes possible sustainability, ethics and social desirability. … The establishment and sharing of global bioethics norms, rules and practices is essential. …Scientific research and the advances it brings can be a key driver of development”.

In order to deal with the new biotechnologies it emphasizes on the importance of addressing related ethical issues in a comprehensive way. As it says, “…however, if the ethical perspective is not taken into account at the same time as the epistemological and methodological considerations, it may not only lead to abuses of human rights, but also to inequality in economic and social development between and within countries. The development of national infra-structures in bioethics, by stimulating the establishment of national bioethics committees and promoting awareness, public debate and bioethics education for all stakeholders is a way to promote systematic decision-making” (UNESCO 2013). It should be noted that this process, from bottom to top and from top to bottom, can contribute to a greater respect for human rights by facilitating the participation of citizens in decisions that affect them. In the UNESCO view, reflection on bioethical issues is as important for scientific development as it is for economic, social and democratic developments.

Though they are often designated in short under the same name of “ethics committees”, it is important to distinguish several types of ethics bodies, working in different contexts and with different missions (UNESCO 2005). Currently, there are four types of ethics committees, (1) National Bioethics Committee s are entrusted with studying fundamental issues and scientific and technological developments, counselling the authorities and informing the public at large. These Committees’ reports and opinions are made public. (2) Clinical Ethics Committees are responsible to examine ethical issues in a hospital or health care organizations. They provide consultation and ethical guidance to healthcare providers, organization as well as patients and their families. (3) Research Ethics Committees are affiliated to a medico-scientific infrastructure or other entity, have as their goal to make sure that scientific research protocols guarantee adequately the rights and interests of involved individuals. (4) Ethics Committees affiliated to health care professional associations. The focus of this chapter is on National Bioethics Committees.


11.2 The Importance of Bioethics Committees at the National Level


In some countries such as Switzerland , the popular “saloon bar” political feeling might be that down-to-earth common sense is enough to provide answers to the bioethical challenges and dilemmas arising from developments in biomedicine. This is similar to the ideas of those who guillotined Lavoisier during the French Revolution on the ground that “the Republic does not need scholars”. This simplistic approach evidently needs to be refined.

The need for such national bodies flows from increasingly rapid scientific progress and the new possibilities opening up, which create tensions between what can and what may be done, both in terms of where and when limits should be put and in regard to the principle of justice and equitable access for all. Health care professionals, researchers, patients and society itself increasingly face crucial issues. In many cases, the traditional principles of medical ethics are not providing the necessary answers. The core mission of NBCs is to examine these issues, in an interdisciplinary effort to ascertain what constitutes responsible action at the interface of the biological sciences, medicine and health care considered in their social context at the national level.

The legislators’ room for manoeuvre is often unclear, particularly in view of the complexity entailed in assessing the developments and interests involved. Law-making is a lengthy and often cumbersome process and laws are rather rigid instruments, which do not render justice to the characteristics of health care and the human relations dimension within it. Basic legal framework has of course to be developed to establish fundaments, for example in transferring in the national setting the principles anchored in the UDBHR. Further, it is a role of a high-level body like the NBC to give advice as to what should be put in the law and what might be the object of other types of rules and regulations, which might be issued by other instances. The same is true for as regards technical matters. It should be understood that Governments and Parliaments, or the Ministry of Health, shall when necessary and relevant promulgate on this basis formal public law documents (be they proper laws or regulations/ordinances/prescriptions of a lower level). The basic function of NBCs is to serve as platform for providing guidance and advice to policy makers and governments in their States. Thus, they can reinforce the role of UNESCO as an international clearing house for ethical issues and increase the audience of UNESCO work and documents. They are among the most important intermediary bodies for the implementation of the UNESCO normative instruments adopted by the member states.

In the light of the new knowledge and possibilities, the National Bioethics Committee s endeavours to clarify issues and produce ethical judgements that are both clear and conducive to discussion. Doing this, it is required to represent the various conceptions on ethics and values. Its opinions are meant to foster debate and ultimately contribute to the well-being of the people concerned and of society. It doesn’t provide ready-made answers, its goal is not to lay down the supposedly only politically or morally correct positions for the country, but it does make a substantial contribution to the discussion among the public and the authorities. Its advices/reports may also be aimed specifically at professionals, educational institutions or indeed economic actors, as the case may be. Thus, preparing opinions and recommendations and communicating them to the intended audiences are now at the forefront of its mission. Again, the work of the committee is not supposed to replace the legislative and political process and its recommendations are not legally binding and do not impinge on the legislative and executive powers, though possibly coming up with draft regulations. However, examining controversial situations and their ethical implications, studying possible alternative approaches forms the bulk of the committee’s work and might sometimes be even more important than its final recommendations, which may not be accepted unanimously by its members or the population at large. Experience shows that the value of the contribution made by the NBC is closely linked to its diversity of viewpoints and the balance between these elements. Without limiting the necessary debate, one of its objectives should be to seek consensus positions. The more its recommendations reconcile an array of relevant ethical views on a potentially controversial subject, the sounder they are as a basis for decision-making.

The fact is that such a body, charged with advising the authorities on major and potentially explosive issues, has today an indispensable role as a source of independent advice giving to policy-makers. It works to the standards of, and in close contact with, the international debate. It is important to note that NBCs work and advice should be an aid to perceiving and evaluating the issues; it is by no means a matter, obviously, of allowing the public authorities to evade their responsibilities by transferring them to a group of State-approved “moral experts”.


11.3 National Bioethics Committee s : Thirty Years of Development


The need to reflect on the ethical dimension of advances in science and technology, as well as the desire to promote informed and transparent public policies that can enhance public health, has led to the establishment of NBCs, across the world. One of the first in its kind is the “US National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research” (1974) that was established as part of the 1974 National Research Act. This Commission is best known for its Belmont Report , which identified fundamental principles for research involving human subjects and was the basis of subsequent federal regulation in this area (The Belmont Report 1979). In the United State s, currently, the “Presidential Commission for the Study of Bioethical Issues” nominated by President Obama, continues the nearly 40-year history of groups established by the president or Congress to provide expert advice on bioethics topics. However, regarding the NBCs in the present meaning, concerned with ethical issues from a general perspective, the “French National Consultative Ethics Committee for Health and Life Sciences” (CCNE), established by President François Mitterrand in 1983, can be mentioned as one of the first bioethics committees with such mandates. This CCNE has celebrated its 30th anniversary in 2013. Its mission was defined as to provide advice on ethical problems and societal questions raised by the progress of knowledge in the fields of biology, medicine and health (CCNE 2013). The issues of medically assisted procreation and experiments on humans were the first to be addressed by the CCNE but its scope of investigation soon extended to other topics. Publishing advisory opinions is one of the CCNE’s key missions. Most often, these opinions are responses to questions referred by stakeholders, for instance from the President of the Republic, Parliament, or scientific associations. However, the Committee may work on “self-refer” questions raised by the members of the Committee. The CCNE aims at encouraging members of the public to reflect on ethical matters and gain a better understanding of the topic under evaluation. The CCNE organizes an annual meeting dedicated to public debate on different bioethical issues.

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Nov 3, 2016 | Posted by in BIOCHEMISTRY | Comments Off on The National Bioethics Committees and the Universal Declaration on Bioethics and Human Rights: Their Potential and Optimal Functioning

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