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Abstract

National Bioethics Committees became an emergent need all over the world after the marked revolution and advances in science and technology which may need different broad professional views and public concern. The ﬁeld of bioethics is complex and has multidisciplinary faces which attracted many international organizations to put remarkable efforts to establish, enhance, and reinforce National Bioethics Committees. This entry will review the history and development of National Bioethics Committees (NBCs), the deﬁnition and different models, the structure, the functions, and the policies of NBCs and state some NBC networks in art.

Introduction

National Bioethics Committees form a unique divergent world, changing and adapting speedily and dramatically in response to marked, rapid revolution and expansion of scientiﬁc knowledge in forms of new biotechnologies, new discoveries and inventions, new treatments, new national governmental policies and strategies, society culture and norms, new national regulations and international agreements, new bioethical debatable dilemmas, and new professional attitudes and perspectives.

The national consultative organs often called bioethics committees or councils have become an indispensible request for countries in addressing a plenty of emerging bioethical issues. The debates, discussions, opinions, and recommendations generated within such committees are highly considered and cared by governments that seek to develop policies that optimally balance between the expected beneﬁts of new scientiﬁc discoveries and their potential risks. Through a constructive, informative, and balanced debate, these committees open space for free and open expression of different, often opposing, viewpoints existing in various sectors of the society. Such debates inevitably extend beyond the boundaries of committee meeting rooms and enrich the understanding of a given bioethical issue among the policy-makers and concerned professionals as well as the general public (UNESCO 2010).

History And Development

The Medical Ethics Committee of Slovenia was established in 1965 and the Comitée Consultatif National d’Ethique in France in 1983. Both claim to be the ﬁrst National Bioethics Committees all over the world. The ﬁrst committee was a Research Ethics Committee. It has a practical focus: it is reviewing research protocols using international guidelines and has its operating procedures aiming at protection of human subjects in research. The work of such committee is often associated with institutional and economic interests. The second one was a policy-advisory body which has a wider and broad focus with intended goal of developing and drafting guidelines and legislation and stimulating public debate. It cannot draw on many internationally accepted guidelines and documents. It therefore has to use an explorative and analytic approach for new ethical issues to help in developing national policies which may be guided by political interests. The main principle of such committee focused on the common good and the public interest (Ten Have et al. 2011).

There were an increasing number of countries which created ofﬁcial bodies to provide advice about bioethics to their executive and legislative branches as well as to the general public. Other examples of National Ethics Committees were in Denmark established in 1987; Tunisia in 1991; Mexico in1992; the USA in 1995; Singapore in 2000; Germany in 2001; Spain, Guinea, and Jamaica in 2007; and Ghana in 2009, and there are many new NBCs following the steps of construction (UNESCO 2010).

In 1996, the US National Bioethics Advisory Commission asked the French National Consultative Committee on Ethics to jointly invite the other NECs to attend an international summit meeting held in San Francisco in conjunction with the Third World Congress of Bioethics. Since then, eight Global Summits have taken place: San Francisco (1996), Tokyo (1998), London (2000), Brasilia (2002), Canberra (2004), Beijing (2006), Paris (2008), and Singapore (2010).

The World Health Organization (WHO) maintains a close collaboration with National Bioethics Committees (NBCs) around the world because of its formal permanent secretariat of the Global Summit (WHO 2010).

According to Bouesseau et al. (2011):“ there are 93 countries (48.2 % of WHO member states) with National Ethics Committees: 22 in the WHO African Region (47.8 % of countries), 13 in the Region of the Americas (36.1 % of countries), 9 in the Eastern Mediterranean Region (42.8 %), 38 in the European Region (71.7 % of countries), 4 in the South-East Asian Region (36.4 % of countries) and 7 in the Western Paciﬁc Region (25 % of countries). Some of these committees are National Ethics Committees dealing with a broad range of ethical issues in health, while others are exclusively or predominantly Research Ethics Committees. Sixty per cent (56) of these committees have some form of publicly accessible website, although not all of them have information in the English language.”

The composition, goals, and functions among NBCs differ from one region to another because of a variety of reasons which may be historical, cultural, or political. The diversity in mandates and missions of NBCs is reﬂected in the range of organizational structures. “National Commissions,” “Advisory Committees,” or “National Bioethics Committees” are terms which could be appointed by chief executives, ministers of health, or legislatures to analyze and offer recommendations about current issues in bioethics especially in ethics of health, when a legislative action or change in national policy is required (Bouesseau et al. 2011).

The Universal Declaration on Bioethics and Human Rights adopted by United Nations Educational, Scientiﬁc, and Cultural Organization (UNESCO 2005a; Huriet 2009) advocates for the establishment of independent, multidisciplinary, and Pluralist Ethics Committees at national, regional, local, or institutional levels (UNESCO 2005b).

The ABC (Assisting Bioethics Committees) project was one of the three major projects of UNESCO in the era of bioethics (UNESCO 2005a). The ﬁrst two projects were Global Ethics Observatory (GEObs) (Ten Have and Ang 2007), concerned with obtaining accurate information about the state of the art of bioethics committees in all countries, and Ethics Education Program (EEP) (UNESCO 2007, which concerned with education and training of the committee’s members.

It is estimated that National Bioethics Committees were established in 12 countries involved in the ABC (Assisting Bioethics Committees) project in the period of 2007–2010 after receiving training courses (in the ﬁrst stage on working methods, in the second stage on bioethics) (Ten Have et al. 2011).

On 26–28 November 2009, an event organized by UNESCO in Mexico City brought together more than a hundred experts representing national bioethics bodies from across the world, as well as regional and international organizations working in the ﬁeld of bioethics under the title of Joint Action for Capacity-Building in Bioethics (JACOB) (UNESCO 2009).

This event was a collaborative effort between UNESCO and the European Commission, funded by EU’s Seventh Framework Program for Research and Technological Development. It aimed at reinforcing bioethics capacities of countries that have recently established or are planning to establish bioethics bodies at the national level (UNESCO 2009, 2010).

UNESCO and WHO have also co-organized two regional summits of the NECs of the Eastern Mediterranean region, in 2007 and 2009. The ﬁrst regional meeting of National Bioethics Committees was organized on 7th of May 2007 in Cairo, Egypt, as a collaborative work between UNESCO and WHO EMRO Ofﬁce. It brought together experts from 15 countries in the region plus representatives of ALECSO (Arab League Educational, Cultural, and Scientiﬁc Organization), GCC (Gulf Cooperation Council), and IOMS (Islamic Organization for Medical Science) (Ten Have et al. 2011).

In addition, the institutional development of NBCs is fostered by the complementary activities and support offered by many international organizations or institutions. Using the platform of the UN Interagency Committee on Bioethics (UNIACB), WHO, UNESCO, the European Commission, and the Council of Europe have over the last years increasingly striven to strengthen synergies and complementarities. Taking advantage of these opportunities, NBCs can strengthen their national role through exchange of information and contribution to international debate.

Conceptual Clarification/Definition

There is no deﬁnite or ofﬁcial deﬁnition of National Bioethics Committees, but it has different names according to its role and job description based on its national demand of the countries. It is termed committee or commission if it has an ofﬁcial role and council in case of consultation or deliberation tasks and advisory board in cases of making recommendations and taking part and consideration in policy-makers decisions (UNESCO 2010).

Whatever the name, a “bioethics committee” is a committee that systematically and continually addresses the ethical dimensions of (a) the health sciences, (b) the life sciences, and (c) innovative health policies. The term “bioethics committee” simply signals that a group (a chairperson and members) is meeting regularly to address issues that are not simply factual, but are profoundly normative (UNESCO 2005b, 2010). The central characteristics of NBCS are independency, multidisciplinary, and pluralism.

Some bioethics committees established at the national level of government address only those bioethical issues that arise in planning and conducting clinical investigations in which human beings are needed as participants. Having consented to participate in clinical research trials, the participants deserve and also often receive their government’s protection from serious risk of harms, especially since they are volunteers, healthy or ill. This protection typically takes the form of regulations governing the researchers’ procedures (UNESCO 2005b, 2006).

Although some of these committees function at the national level of government, they are actually Research Ethics Committees usually established and worked at local government level. At the national level, however, their titles may be “National Advisory Board on Research Ethics,” “National Ethics Committee for Clinical Investigation,” “Committee of Bioethics – National Committee for Research Ethics in Science and Technology,” “National Committee for Medical Research Ethics,” “Medical Research Council Ethics Committee,” and “Health Research Council Ethics Committee” (UNESCO 2005b).

Ethical Dimension

The Purposes Of National Bioethics Committees (Advisory Committees)

There are main purposes of NBCs described by UNESCO (2005b):

To advise governments, parliaments, and other governmental bodies on bioethical problems and issues raised by progress in health care, biology, the biomedical sciences, and biotechnology.
To publish recommendations on bioethical issues and thereby inﬂuence policy-making and increase public awareness and participation. When government advisers need to respond to advances in the basic and behavioral sciences as well as biotechnology, such recommendations may serve to inﬂuence the formation of new legislation and contribute to public awareness and debate.
To provide a forum for discussions at the national level of a plethora of bioethical problems, issues, and particular cases that have received public attention through extensive media coverage, e.g., press conferences, publications, television, and the Internet.

Forms of Bioethics Committees and Its Goals Four forms of bioethics committees were deﬁned by UNESCO (2006): (1) Policymaking/or Advisory (PMA) Committee to establish sound science and health policies for member states’ citizens, (2) Health Professionals Association (HPA) Committees to establish sound professional practices for patient care (physicians’ associations), (3) Healthcare/Hospital Ethics Committees (HEC) to improve patient-centered care (hospitals, outpatient clinics, long-term care institutions, hospices), and (4) Research Ethics Committees (REC) to protect human research participants while acquiring generalizable biological, biomedical, behavioral, and epidemiological knowledge (pharmaceuticals, vaccines, devices).

Models And Approaches Of NBCs

There are different models and approaches of NBCs in existence. Some committees are connected to government as in the USA (President), France and Brazil (separate legal entity), Switzerland (parliament), Gabon (Ministry), and Guinea (entity within ministry). Other committees are connected to nongovernmental organizations as in Madagascar and Tajikistan (Academy of Science), the UK (Charity), Sri Lanka (National Science Foundation), and Azerbaijan (Medical Association). Other committees are created by the National Commission for UNESCO (e.g., in Ecuador and Egypt (UNESCO 2005b; Ten Have et al. 2011)).

Functions Of NBCs

The important function of bioethics committees is to undertake fundamental inquiries into the human and moral signiﬁcance of developments in the biological and behavioral sciences and biotechnology and to become familiar with the regulations regarding the protection of adults and children who participate in clinical trials (UNESCO 2005b).

The committee must also appreciate the consequences of regulating, limiting, or restricting biological and behavioral research involving human participants. In addition, it should offer a platform to deliberate the appropriate uses of biological and biomedical technologies. The committee is also the proper place to reﬂect on the moral and cultural implications of innovative biological technologies in order to determine whether they require the formulation of new rules and regulations at the national level (UNESCO 2005b, 2006).

It is expected to explore speciﬁc bioethical policy questions related to these developments, facilitate a greater understanding of bioethical problems, and study broader bioethical problems and issues not necessarily tied to speciﬁc technologies.

These tasks should not only be implemented by members of the various health professions and the scientiﬁc community but also by media professionals and the lay public. Finally, the committee should explore possibilities for productive collaboration among member states on particular bioethical problems, dilemmas, and cases (UNESCO 2006).

National Bioethics Committee Size

NBCs may be composed of as many as 40 members (e.g., France’s Comité Consultatif National d’Ethique) or as few as 18 members (e.g., the US President’s Council on Bioethics). As with most committees, commissions, and councils at the national level, a reasonable balance must be addressed: neither too few nor too many members. Small size tends to encourage efﬁciency and consensus building, though at the price of uniformity, while large size more easily accommodates representativeness and diversity, though at the price of efﬁciency and internal cohesion (UNESCO 2006).

General Procedures And Policies Of NBCs

Procedures and policies of National Bioethics Committees were well described by UNESCO (2006). Each committee should be assigned a mission statement which outlines its goals. Policy and operational procedures should be separate and distinct from the other committees or institutional bodies. Procedures for the recruitment of committee members must be set out. The actual appointment of the chairperson and members must follow regulated and transparent procedures.

Criteria for membership should be clear. Thus, if a committee is to represent various constituencies, these should be listed and the number of seats granted to each constituency made explicit. Typically, basic scientists, clinical researchers, physicians, nurses, pharmacists, bioethicists, clergy, health lawyers, behavioral scientists, social workers, patient advocates, administrators, laypersons, and public ofﬁcials are among the relevant categories represented.

Some considerations should be taken in building up committee procedures and policy: ﬁrst is the extent to which the committee should be independent of the granting ofﬁcial and the second is stability. A third consideration is the interpretation given to a committee’s mandate to be representative.

Particular issues should be addressed in an orderly fashion in committee agenda, and votes would reveal exactly the extent of support and opposition on speciﬁc issues. An alternative path would be to proceed informally and seek consensus.

Policy should include periodical revision of the committee’s mandate and determine if it should be extended to include additional function, to determine how the media and the public will be informed of the committee’s activities (advising, recommending, or decision-making), and to establish a bioethics self-education programs for present and future chairpersons and members (UNESCO 2006).

Recruiting Chairperson And Committee Members

Key government ofﬁcials, e.g., ministers of health or members of their staff, may take the initiative to nominate a highly respected and knowledgeable person to serve as chairperson, as well as to suggest the names of potential members to serve on a bioethics committee at the national level (UNESCO 2010).

Regarding bioethics committees, it is important that a number of members selected have been educated in a health profession and have had scientiﬁc training as well.

Chairpersons tend to favor maximizing their inﬂuence over the selection of members, arguing that this is necessary to ensure efﬁcient operation of the committee and may agree to serve in this capacity only if he or she is given the authority to select the committee’s members on the basis of a number of criteria and procedures (UNESCO 2006).

The chairperson may take the initiative personally to contact a number of qualiﬁed persons and invite them to serve as members of the committee and may also accept nominations by or without invitation. He/she may decide to cast a wide net to locate qualiﬁed candidates to serve on a newly established National Bioethics Committee. There is a valuable criticism regarding granting the chairperson inﬂuence over the committee’s membership and agenda as a serious ﬂaw. It may virtually guarantee dominance of the chairperson, thus destroying much of the rationale for creating the committee. So, selection of chairperson and superior authority on all policies and procedures of committee should be revised (UNESCO 2006).

Concerning committee members recruitment, expertise and representativeness are two main key criteria for selection. An extra important criterion embraces character: integrity, collegiality, and industriousness for members who must work together to keep the committee from collapsing due to bickering and betrayals.

When establishing and organizing bioethics committees, whether as policy-makers or advisory bodies to government leaders, it is important to appoint professional bioethicists (philosophers and/or theologians) as well as professionals who have extensive experience in a few areas, e.g., a scientist who has held a post as a health policymaker; perhaps he or she has been a member of a state’s government, a member of parliament, a minister of health, or a member of an advisory board at the highest level of government. Furthermore, these advisory or policy-making committees should be councils on bioethics, not of bioethicists; they should, in short, be heterogeneous (UNESCO 2005b, 2006).

Finally, the committee must seek credibility from the outset; it should not be viewed as “of one mind” or the tool of government or a contesting interest. In short, the committee should be free of the obligation to seek consensus among its members. This can be made transparent when the committee publishes its reports, which should include dissenting views. A full-detailed description of chairperson and members’ recruitment, procedures, and policy of NBCs was published by UNESCO (2006).

Training And Support Of NBCs

Experiences in the ABC project of UNESCO showed that sustainability is a serious challenge. Ten Have et al. 2011 concluded that there is a need for on-site training programs and involvement of committee members in an extensive course. Also, capacity building of the secretariat needs to be assured by internships and sharing of experiences with more experienced committees and help of experts. They assumed that the Internet resources are often not easily accessible in all developing countries and bioethics documentation is often lacking.

Bioethics documentation was provided by the National Reference Center for Bioethics Literature in Georgetown University (USA) in collaboration with ABC project, but it is clear that more efforts will be required, especially in francophone countries. The ABC project also includes internships for secretariat members as well as partnership with experienced well-established committees (Ten Have et al. 2011).

International And Regional Networking

Active exchange of experiences between the existing committees is considered another modality of capacity building. The newly established committees are encouraged to become members and actively participate in the existing networks, both regional and international, in order to share experiences and enhance competencies (UNESCO 2009, 2010). Some of the existing initiatives that create international as well as regional networks include:

(a) The Global Summit of National Bioethics Advisory Bodies held 7th Global Summit in 2008 in Paris and 8th one in 2010 in Singapore (Bioethics Advisory Committee et al. 2010).

(b) Regional networks can be very effective in enabling NBCs from the same region to share lessons learned and best practices on issues of common concern. A signiﬁcant step toward promoting NBC networks at the regional level was taken at the European Commission – UNESCO Conference: Joint Action for Capacity-Building in Bioethics (JACOB) in Mexico City, Mexico, on 26–28 November 2009 (UNESCO 2009), when more than 100 participants representing national bioethics bodies, as well as regional and international organizations working in the ﬁeld of bioethics, conﬁrmed their commitment to promote regional bioethics networks and asked UNESCO and its partners for assistance in this regard.

(c) National Bioethics Committees Network of the CIS region: The Congress “Bioethics and Human Rights,” held in September 2008 in Kazan, Russian Federation, initiated the creation of Regional Network of National Bioethics Committees of CIS countries.

(d) Western and Central African Bioethics Forum: The establishment of Western and Central African Bioethics Forum is currently in progress.

Hoping more networks to be constructed for more promotion and reinforcing the capacity building of newly established NBCs and in formation and establishing of new ones in countries which have not it yet.

Conclusion

Advances of biological and medical research and developments in technology raised some ethical issues that may affect the individual and protection of the individual’s rights and dignity (genetics, transplantation, biobanks, emerging technologies, etc.). These debatable ethical issues may request the need of broad professional views and public concern which is called National Bioethics Committee.

These National Ethics Committees differ case by case. Yet, they usually share certain features: ﬁrst, they usually recruit together people with different backgrounds such as medical training, philosophical training, religious concerns, and so on. Second, they usually make decisions jointly after negotiations, discussions, and procedures which vary from one committee to another. Third, the number of members in these committees is limited, so that they can carry meaningful dialogue in face-to-face debates.

An operational National Bioethics Committee can be a driving force for the growth of bioethics in a country if it showed lack of expertise, ethics education, public debate, professional concern of bioethics, and regulatory frameworks (UNESCO [internet] 2010).

The requirement of establishing National Bioethics Committees is not limited to a speciﬁc tragedy or scandal or to the practices of medicine with advanced technology or researchers in one country; they are meant to be universal in all countries, although their establishment and practical application will require adaptation to particular cultures, health conditions, and economic settings and political norms.

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