Pays européens de I à Z

Comités nationaux de bioéthique ou d'éthique des sciences

Irish bioethics council, Irlande

Naissance: 2002. The Irish Council for Bioethics (Comhairle Bitheitice na hÉireann) was established in 2002 as an independent, autonomous body to consider the ethical issues raised by developments in science and medicine. The establishment of the Council was recommended by the Government Report of the Inter-Departmental Group on Modern Technology published in 2000. The Royal Irish Academy was invited to establish the Council by the Department of Enterprise, Trade and Employment. The Academy's role is that of nominating the membership and providing the secretariat for the Council. The Council is however independent of the Academy. The Council is funded by a grant from Ireland's National Policy and Advisory Board for Enterprise, Trade, Science, Technology and Innovation (Forfás).

Mission: Terms of Reference

-To identify and interpret the ethical questions raised by biomedicine in order to respond to, and anticipate, questions of substantive concern.

-To investigate and report on such questions in the interests of promoting public understanding, informed discussion and education.

-In light of the outcome of its work, to stimulate discussion through conferences, workshops, lectures, published reports and where appropriate suggest guidelines.

Publications :

Ethical, Scientific and Legal Issues Concerning Stem Cell Research Opinion 2008,

Environmental Ethics: Global Solidarity in a Sustainable Future 2007

Bioethics Information Leaflet Series 2007

Stem Cell Science Information Leaflet 2007

Ethical Dilemmas in a Pandemic 2006

Is it time for Advance Healthcare Directives? Opinion 2007

Introduction to Bioethical Issues 2006/2007

Genetically Modified Crops and Food : Threat or Opportunity for Ireland? Opinion 2005

Public Attitudes Towards Bioethics : Irish Council for Bioethics Research Report 2005

Human Biological Material: Recommendations for Collection, Use and Storage in Research 2005

Operational Procedures for Research Ethics Committees: Guidance 2004

Bioethics events :

Governing Biobanks - What are the challenges? St. Anne's College, Oxford, UK, 24-26 June 2008

First International Conference of the Tiss.EU project: Ethical & Legal Aspects of Research with Human Tissue in Europe University Medical Center Gottingen, Germany, 26-28 June 2008

Nursing Ethics & Health Care Policy: Bridging Local, National & International Perspectives New Haven, Connecticut, USA, 17-19 July 2008

Predicting Our Future: Genetic Testing in Children and Their Families Seattle, Washington, USA, 25 July 2008 Genetic testing in children can be used for diagnosis, the prediction of future disease or selecting the best therapy for an individual child.

7th Meeting of the Global Summit of National Bioethics Advisory Bodies Paris, France, 1-2 September 2008

9th World Congress of Bioethics Rijeka, Croatia, 3-8 September 2008 Organised by the International Association for Bioethics.

EACME Conference 2008: Organising Bioethics - Challenges for Western, Central and Eastern Europe Prague, Czech Republic, 25-27 September 2008

11th World Congress on Controversies in Obstetrics, Gynecology and Infertility Paris, France, 27-30 November 2008

Analyse ou remarques:

National Bioethics Committee, Islande

Mission :

- The main role of the National Bioethics Committee is the evaluation of applications for research proposals incorporating the participation of human subjects and concerning health issues in one way or the other.

The evaluation of the National Bioethics Committee pertains to both the scientific and ethical issues concerning the proposed research project, as stated in the Act on the rights of patients.

- The regulation further states that the National Bioethics Committee evaluates collaborative projects, international research projects and other research proposals that do not come under the mandate of the institutional ethics committees previously mentioned (see Article 3 in reg. no. 552/1999). Furthermore, the decisions of the institutional ethics committees previously mentioned may be appealed to the National Bioethics Committee

- National Bioethics Committee has a supervisory role defined by law, with regards to research project the committee has previously approved. Such supervision pertains to e.g. complaints or comments that the committee receives from participants in these projects. The supervisory role of the national Bioethics Committee is defined in the Regulation on Scientific Research in the Health Sector.

Analyse ou remarques : Ne semble pas avoir pour première mission d'émettre des avis sur des enjeux éthiques potentiels mais plutôt de siéger à titre d'instance d'appel.

National Bioethics Committee, Italie

Historique : The setting up of the National Bioethics Committee followed resolution no. 6-00038 approved on 5 July 1988 in which the Chamber of Deputies, among other things, committed the Government to promoting an international level comparison on the state of the art of biomedical research and genetic engineering which might serve as a valid point of reference for future choices in which the progress of science can be reconciled with the respect for human freedom and dignity. The National Bioethics Committee was established by a decree signed by the President of the Council of Ministers on 28 March 1990.

Mission :

- to make, if necessary by exercising its faculty to access the required information in the existing national operating centres, as well as by liaising with similar committees set up in other countries and other international organizations operating in the sector, an outline summary of the programmes, objectives and results of research and experimentation in the field of the life sciences and human health;

- to express opinions and suggest solutions, also for the purpose of preparing legislative acts, to address the ethical and legal problems that may emerge as a result of the progress of research and the emergence of possible new applications of clinical interest, taking into account the safeguarding of fundamental human rights and human dignity and the other values as expressed in the Constitutional Charter and in the international instruments supported by Italy;

- to propose solutions for the functions of control over both the safeguarding of human and environmental security in the production of biological material and the protection from all risk of all patients treated with products produced by genetic engineering or who are subjected to gene therapy; - to promote the drawing up of codes of conduct for practitioners operating in the various sectors concerned and to encourage the proper informing of public opinion.

La saisine du Comité : The National Bioethics Committee is a consultative body of the Presidency of the Council of Ministers and it may be tasked by members of the Government, of the Parliament and of other institutions. Associations, research centers, local ethics committees, scholars and single individuals can address themselves to the Committee for information regarding bioethics.

Avis :

Ritual slaughtering and Animal Suffering 2003

Tobacco use 2003

Advance treatment directives 2003, doc. Word

Psychiatry and Mental Health: Bioethical Guidelines 2000

Opinion of the National Bioethics Committee on the therapeutic use of stem cells 2000

Protection of the human embryo and foetus. Opinion of the NBC concerning the preliminary draft protocol of the Bioethics Committee of the Council of Europe 2000

NBC declaration on the possibility of patenting human embryo cells 2000

[http://www.governo.it/bioetica/eng/opinions/protocol.html/ Opinion of the National Bioethics Committee on the European protocol on biomedical research) 1999

Premiers avis :

Opinion on the proposed resolution concerning assistance of terminally ill patients, 1991

Document on the safety of biotechnologies, 1991

Problems involved in collecting and treating human seminal liquid for diagnostic purposes, 1991

Definition and determination of human death, 1991

Gene therapy, 1991

Remarque : Aucun avis ne semble avoir été émis depuis 2003.

The Lithuanian Bioethics Committee, Lituanie

Historique : The Lithuanian Bioethics Committee (LBEC) is an institution which is responsible for the protection of human rights and dignity in the field of health care. It was established at the end of 1995 following the Law on the Lithuanian Health Care System. The Committee operates according to the decree of the Ministry of Health issued on the 27th of December, 1995. LBEC has been appointed by the Minister of Health. These objectives are accomplished by two networks of ethics committees: regional research ethics committees and ethics committees in the largest Lithuanian hospitals.

Mission :

- to inform and educate the biomedical community and general public on moral dilemmas arising in the context of modern health care. In particular the issues dealt with are : informed consent; privacy and confidentiality; reproductive rights; ethical issues of genetics; abortion; death and dying, palliative care; refusal of life-sustaining treatment and euthanasia; ethical issues of biomedical research; involuntary treatment; decisions on behalf of the mentally handicapped; ethical issues of organ procurement and transplantation; allocation of scarce resources;

- to protect patients’ rights in the fields of biomedical research and clinical practice as well as to coordinate the ethical review of research protocols in Lithuania.

- responsible for methodological support for regional and local ethics committees, for

organizing workshops and conferences as well as translating, publishing and disseminating relevant material on biomedical ethics within society and the biomedical community.

- as a consulting body LBEC also takes part in the process of health care legislation related with ethical issues.

Activités :

Projects:

- BioTethed: Biotechnology Ethics

- Strategy for the Development of Health Care Ethics, 2000-2002

- Creation of the Web Site of the Lithuanian National Committee on Biomedical Ethics, 1999-2000

- Development of Bioethics Committees within Lithuanian Heath Care, 1998-2002

- Patients’ Rights in Lithuania: Situation Analysis and Community Empowerment, 2001-2002

- Teaching Patients’ Rights at School, 2002

Events:

- The Eighth Global Forum on Bioethics in Research, June 27-29, 2007, Vilnius

- Bioethics in Europe and Lithuania, 23-24 September, 2005

- Workshop “Patients’ Rights and Developments of Health Care Ethics in Central and Eastern Europe”, Vilnius, 21-23 August, 2004 (download programme)

- Regional Seminar on Training in Research Ethics, Vilnius, 24-25 May 2004 (download programme)

- Teaching course “Introduction to Bioethics” Vilnius, 11-14 May, 2004 (the course was organised in the framework of the project “European Hospital (-based) Bioethics Program (EHBP)” sponsored by the European Comission),

- XVII ESPMH (European Society for Philosophy of Medicine and Healthcare) Conference, 21-23 August, 2003

Commission Consultative Nationale d'Ethique pour les sciences de la Vie et de la Santé (C.N.E.), Luxembourg

Historique : La Commission Consultative Nationale d'Ethique pour les sciences de la Vie et de la Santé fut mise en place par le gouvernement à la date du 9 septembre 1988. Elle ne put faire débuter toutefois ses travaux qu'en 1989. Les membres sont nommés par le Gouvernement. Les Avis de la C.N.E. ont trois destinataires : le Gouvernement qui, sauf en cas d'auto-saisine, en est d'ailleurs le commanditaire, le pouvoir législatif, la société civile. La mission de la Commission Nationale d'Ethique consiste notamment à étudier, soit de sa propre initiative, soit à la demande du Gouvernement, les aspects éthiques tant des problèmes divers, soulevés dans le domaine des sciences de la vie et de la santé que des solutions et des moyens à mettre en oeuvre.

Le travail de la C.N.E. doit obéir à plusieurs exigences :

Multidisciplinarité : Son objet est constitué, pour l'essentiel, par la thématisation et la résolution de problèmes éthiques. Ces problèmes sont soulevés tant par les rapides progrès des sciences de la vie que par la complexité des situations auxquelles sont confrontées, de nos jours, la recherche et la médecine. Ils peuvent, d'autre part, avoir leur origine dans les transformation de nos sociétés et dans les adaptations de leur horizon normatif. Certains problèmes ont en effet, leur origine dans les modifications, parfois insensibles, parfois nettes des valeurs et exigences normatives gouvernant la société. La résolution de ces problèmes éthiques consistent, pour l'essentiel, dans un prudent équilibrage de valeurs et d'exigences normatives rivales. Bien que la partie centrale en soit constituée par des problèmes éthiques, la bioéthique ne peut être que pluridisciplinaire. Elle l'est dans la mesure où l'identification, la thématisation et l'articulation des problèmes éthiques est, largement, l'affaire des chercheurs engagés, notamment, dans les domaines de la biologie, de la génétique, de la recherche biomédicale. Elle est l'affaire, pareillement, des médecins, des personnels de soins, des patients, de leurs proches.

Pluridisciplinarité : Autant qu'il doit être multidisciplinaire, le débat mené dans les commissions nationales d'éthique doit être pluriel. C'est dire que les débats doivent être menés dans un esprit de pluralisme. Elle doivent tenir compte de la complexité de l'horizon normatif de nos sociétés et s'efforcer de projeter, dans le dialogue, des solutions transcendant, pour autant que possible, les clivages existants. L'un des objets (essentiels) des commissions nationales d'éthique est de conseiller des gouvernements présidant à la destinée de nations traversées par de profonds clivages sociaux, culturels et normatifs. Les recommandations des commissions d'éthique doivent répondre aux exigences dictées par cette situation. Leurs recommandations doivent, dans toute la mesure du possible, reposer sur des valeurs et exigences normatives communes à une large majorité de citoyens.

Consensualité : Afin que les débats correspondent aux exigences, les commissions d'éthique doivent être composées de manière à refléter les clivages culturels et normatifs de la société,explorer avec prudence et ténacité tant l'horizon normatif des membres que la nature concrète des situations et des contextes. Dans cette optique, ils doivent tenter de s'accorder, autant qu'il se peut, sur des solutions consensuelles, transcendant les clivages normatifs. Même en cas de dissensions substantielles, la Commission Nationale d'Ethique a toujours évité, au fil des années, d'opposer Avis majoritaire et prises de position minoritaires. Elle s'est efforcée d'aboutir, dans toute la mesure du possible, à des consensus aussi larges que possibles. Chaque fois que ceux-ci ne pouvaient pas être obtenus, elle s'est employée à rédiger des Avis documentant, objectivement, les orientations de l'ensemble des membres, et acceptés, en tant que tels, par tous de manière unanime.

Mission :

- informer le public sur la nature et l'objet des problèmes bioéthiques ;

- entrer en discussion avec la société civile (publier régulièrement ses Avis, organiser, annuellement, une Journée Nationale d'Ethique ayant pour objet, notamment, de susciter, d'alimenter et d'animer un débat public consacré aux problèmes de bioéthique) ;

- demeurer en contact suivi avec les chercheurs dans le domaine des sciences biomédicales.

- exiger de la part de ses membres la disponibilité de se former régulièrement dans le domaine de l'éthique biomédicale. De même, la Commission a le souci d'élargir le champ des opinions en se confrontant à la pluralité des positions véhiculées dans la société luxembourgeoise.

Avis 21 - Le diagnostic de la mort en rapport avec le don d'organes 2008 (270 Ko)

Avis 20 - Les limites de l'accès aux soins de santé au Grand-Duché de Luxembourg 2007 (1200 Ko)

Avis 19 - Bref Avis sur le projet de loi n° 5448 relatif aux tissus et cellules humains utilisés à des fins thérapeutiques 2005 (69 Ko)

Avis 2004.1: Le clonage reproductif d'êtres humains 2004 (252 Ko)

Avis 2002.2, 2002.3 et 2003.1: La recherche sur les embryons I et II. Note complémentaire sur la Convention d´Oviedo. Les essais cliniques portant sur des médicaments à usage humain. (1170 Ko)

Avis 2002.1: Inventions biotechnologiques et brevets (924 Ko)

Avis 2001.1: La procréation médicalement assistée (P.M.A.) (829 Ko)

The Norwegian Biotechnology Advisory Board, Norvège

The Norwegian Biotechnology Advisory Board is an independent body consisting of 24 members appointed by the Norwegian government. Each member has a background and/or education which makes him/her competent to discuss questions regarding modern biotechnology. Eight members of the board represent different public organisations.

Mission :

- to evaluate the social and ethical consequences of modern biotechnology

- to discuss usage which promotes sustainable development

The Norwegian Biotechnology Advisory Board publishes the free, quarterly journal "Genialt" in Norwegian. In addition it makes information pamphlets on various topics regarding modern biotechnology.

Bioethics Appeals Commission, Pologne

Création :

Legal basis of its creation

functions on the basis of Art. 29 item 5 of the law of December 5, 1996 (Journal of Law of 2002 No. 2, pos. 204, and No. 76, pos. 691),

appointed by the Minister of Health on January 17, 2001 (regulation of the Minister of Health of July 24, 2001, regarding the appointment of and rules of procedure of a Bioethics Appeals Commission - Journal of Regulations of the Ministry of Health No. 8, pos. 47, and No. 134, pos. 81 - as well as the regulation of the Minister of Health of June 28, 2002, regarding the appointment of an Bioethics Appeals Commission - Journal of Regulations of the Ministry of Health of 2002 No. 7, pos. 35).

Rules of procedure: the regulation of the Minister of Health and Social Welfare of May 11, 1999 (Journal of Laws No. 47, pos. 480) concerning the particular rules of appointing and funding as well as the procedure of bioethics committees,

the bylaws of the Bioethics Appeals Commission [ www.mz.gov.pl]

Mission :

- considering appeals against decisions of the bioethics committees of the regional chambers of physicians, institutions of higher medical education, as well as institutions of higher education with departments of medicine, and also medical research and development institutions, hereinafter "bioethics committees",

- keeping a record of appeals and resolutions,

- storing the documentation of an experiment,

- presenting the Minister of Health with an annual report of the Board's work,

- cooperating with bioethics committees, organizing meetings and training for the members of bioethics committees.

National Medical Ethics Committee, Slovénie

Medical Ethics in Slovenia

Establishment of Research Ethics Committees (RECs) :

Since the 1960s there has been a formal system for ethical review of medical research in Slovenia. Although there is no specific law regulating biomedical research on humans the Oviedo Convention1 has been in force since 1 December 1999. This important legally binding international instrument contains rather detailed provisions on biomedical research. There is also a long-standing practice, of over 40 years, of ethical review of medical research.

Slovene Regulation Regarding Biomedical Research :

National Regulations on Ethics and Research in Slovenia

The Swedish National Council on Medical Ethics, Suède

The Swedish National Council on Medical Ethics is a national body with an independent status within the Government offices. Administratively, the council is affiliated with the Ministry of Health and Social Affairs. The council is an advisory board to the Swedish government on ethical issues raised by scientific and technological advances in biomedicine. Issues that are disucssed may either have been referred to the council, or may have been identified by the council itself. The discussions may result in an official statement of opinion, which is most frequently addressed to the Minister of Health and Social Affairs.

Mission:

- The Council shall stimulate exchange of information and ideas ;

- to promote discussion on new medical research and applications.

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Comités nationaux de bioéthique ou d'éthique des sciences