Éthique médicale

Codes of ethics for pharmacists ( Luxembourg )


Arrêté ministériel du 11 juillet 2011 approuvant le code de déontologie des pharmaciens édicté par le Collège Médical(107.2 KB)

Source : http://data.legilux.public.lu/eli/etat/leg/amin/2011/07/11/n1/jo

Codes of ethics for the medical and dental professions ( Luxembourg )

Arrêté ministériel du 1 mars 2013 approuvant le code de déontologie des professions de médecin et de médecin-dentiste édicté par le Collège Médical(171.5 KB)

Source : http://data.legilux.public.lu/eli/etat/leg/amin/2013/03/01/n1

Codes of ethics of certain health professions ( Luxembourg )

Règlement grand-ducal du 7 octobre 2010 établissant le code de déontologie de certaines professions de santé.

Nous Henri, Grand-Duc de Luxembourg, Duc de Nassau,

Vu l'article 19 de la loi modifiée du 26 mars 1992 sur l'exercice et la revalorisation de certaines professions de santé;

Vu l'avis du Conseil supérieur de certaines professions de santé;

Notre Conseil d'Etat entendu;

Sur le rapport de Notre Ministre de la Santé et après délibération du Gouvernement en Conseil;

Arrêtons:

​

Art. 1er.

Le code de déontologie de certaines professions de santé, annexé au présent règlement, est applicable à toute personne autorisée à exercer une profession de santé visée par la loi modifiée du 26 mars 1992 sur l'exercice et la revalorisation de certaines professions de santé.

​

Art. 2.

Notre Ministre de la Santé est chargé de l'exécution du présent règlement qui sera publié au Mémorial ensemble avec son annexe qui en fait partie intégrante.

Le Ministre de la Santé,

Mars di Bartolomeo

Château de Berg, le 7 octobre 2010.

Henri
​

Annexe

Code de déontologie de certaines professions de santé

Préambule

Le présent code de déontologie est destiné à servir de ligne de conduite générale pour toutes les professions de santé autorisées à être exercées au Grand-Duché de Luxembourg selon la loi modifiée du 26 mars 1992 sur l’exercice et la revalorisation de certaines professions de santé.

Les règles de conduite énoncées dans ce code sont d’application ensemble avec la loi modifiée du 26 mars 1992 précitée et des règlements pris en son exécution dans tout conflit qui pourrait survenir dans l’exercice d’une profession de santé. Les exigences du public, de l’employeur, d’un organisme ou de la personne prise en charge peuvent placer le professionnel de santé en conflit d’intérêts. Dans tous les cas où les devoirs et obligations éthiques ou les responsabilités dictées par le présent code risquent d’être enfreints, le professionnel de santé doit agir conformément aux prescriptions du présent code.

Chaque professionnel de santé dispense les actes, prestations ou services relatifs à sa profession respective dans le respect des règles déontologiques et dans le but de promouvoir la santé. La santé se définit comme un état complet de bien-être physique, mental et social, et ne consiste pas seulement en une absence de maladie ou d’infirmité.

Chapitre Ier.

Devoirs généraux des professionnels de santé dans leur exercice professionnel

Art. 1er.

Les dispositions du présent code de déontologie s’imposent à toute personne autorisée à exercer au Grand-Duché de Luxembourg de façon définitive, temporaire ou exceptionnelle une profession de santé visée par la loi modifiée du 26 mars 1992 sur l’exercice et la revalorisation de certaines professions de santé. Les infractions aux dispositions du présent code relèvent de la juridiction disciplinaire du Conseil de discipline pour les professions de santé régies par la loi précitée.

Art. 2.

La qualité des prestations des professionnels de santé n’est jamais influencée par des considérations de race, de sexe, d’âge, de nationalité, de religion, de statut social, d’état de santé, de tendance sexuelle ou de conviction socio-politique. Le professionnel de santé ne doit jamais se départir d’une attitude correcte et attentive envers la personne prise en charge.

Art. 3.

Le professionnel de santé exerce sa mission dans le respect de la vie humaine, de la personne, de la dignité et des droits de celle-ci. Le respect dû à la personne ne cesse de s’imposer après sa mort.

Art. 4.

Le professionnel de santé ne doit jamais assister ni participer à des actes de torture ou formes de traitements cruels, inhumains ou dégradants ni les admettre, quels que soient les arguments et ce dans toutes les situations y compris en cas de conflit civil ou armé. De même, le professionnel de santé ne doit jamais utiliser ses connaissances, sa compétence ou ses aptitudes en vue de faciliter l’emploi de la torture ou de tout autre procédé cruel, inhumain ou dégradant utilisé à quelque fin que ce soit.

Art. 5.

Hormis le cas d’urgence vitale où il agit dans les limites de ses connaissances et de son savoir-faire, le professionnel de santé se limite dans le cadre de son exercice aux attributions spécifiques de sa profession.

Art. 6.

Le professionnel de santé veille à exercer sa profession selon les règles de l’art. Les prestations professionnelles sont réalisées selon le principe de la meilleure efficacité, de la moindre nocivité, du respect de l’autonomie et avec la même conscience professionnelle à l’égard de tous les bénéficiaires et des autres prestataires impliqués.

Art. 7.

Dans le cadre de ses attributions professionnelles spécifiques le professionnel de santé veille, en ce qui le concerne, à l’application correcte notamment:

– ​ des règlements, conventions et autres instructions,
– ​ des modes d’emploi des équipements, produits et matériels utilisés,
– ​des règles d’hygiène, de sécurité et de santé au travail.

Art. 8.

Le professionnel de santé ne peut exercer une autre activité professionnelle que si un tel cumul est compatible avec la dignité professionnelle et s’il n’est pas exclu par les réglementations en vigueur.

Art. 9.

Le professionnel de santé peut participer à une campagne sanitaire, à une émission radiodiffusée ou télévisée, destinée à l’éducation du public, et donner des conférences, à condition d’observer le secret professionnel, les règles de discrétion, de dignité, de tact et de prudence propres à toute profession de santé. Le professionnel de santé évitera dans ce contexte toute publicité personnelle conformément à l’article 38 du présent code.

Art. 10.

Le professionnel de santé dont l’activité professionnelle fait l’objet d’une publication dans les médias, doit veiller dans la mesure du possible à ce que la publication des informations se fasse de manière objective et non tapageuse.

Art. 11.

Sont interdites toutes les supercheries et tromperies propres à nuire aux personnes prises en charge et notamment toute pratique de charlatanisme et les pratiques qui y ont recours. Le professionnel de santé ne doit en aucun cas faciliter ou couvrir directement ou indirectement l’exercice illégal d’une des professions de santé visée par la loi modifiée du 26 mars 1992 précitée.

Chapitre II.

Devoirs des professionnels de santé envers les personnes prises en charge

Art. 12.

Le professionnel de santé encourage la personne prise en charge à participer activement aux prestations. Dans ce contexte, il respecte la personnalité et le droit au libre choix de la personne et la fait participer si nécessaire aux prises de décisions, si elle en est capable. Le libre choix du traitement se manifeste par le consentement éclairé. Toutefois, en cas d’urgence vitale, le raisonnement éthique professionnel peut exiger du professionnel de santé des interventions sans le consentement éclairé de la personne.

Art. 13.

Le professionnel de santé s’engage à ne pas utiliser des techniques qui feraient courir un risque injustifié à la personne prise en charge. Le professionnel de santé ne doit diffuser dans les milieux professionnels ni technique ni procédé insuffisamment éprouvés sans accompagner cette diffusion des réserves qui s’imposent.

Art. 14.

Lorsque le professionnel de santé participe à des recherches biomédicales ou autres, il doit le faire dans le respect de la législation applicable et des dispositions du présent code.

Art. 15.

Le secret professionnel s’impose à chaque professionnel de santé dans les conditions fixées par la loi. Le secret professionnel est un droit dans le chef des personnes prises en charge. Le professionnel de santé doit garantir le secret total de tout ce dont il a pris connaissance dans l’exercice de sa profession; non seulement ce qui lui a été confié, mais aussi ce qu’il a vu, entendu ou compris. Le secret professionnel s’étend au-delà de la mort des personnes prises en charge. De même, l’obligation au secret professionnel face aux tiers ne peut être considérée comme éteinte par le simple consentement du client.

Art. 16.

Le secret professionnel repose sur la conscience du détenteur du secret. Le professionnel de santé ne peut déroger au secret professionnel que dans les cas autorisés par la loi. Lorsque le professionnel de santé discerne au cours de l’exercice de sa profession qu’un mineur, une personne handicapée, une personne privée de liberté ou toute autre personne, est exposée à un péril grave ou victime de sévices ou de privations, il doit mettre en œuvre les moyens adéquats pour protéger la personne concernée, et le cas échéant, alerter les autorités compétentes.

Art. 17.

Chaque professionnel de santé documente selon sa méthode professionnelle ou, le cas échéant, celle de son employeur, ses prestations de façon chronologique au dossier de la personne prise en charge.

Art. 18.

La collecte et l’enregistrement sur support informatique de données nominatives à caractère personnel ne peuvent se faire que dans le respect de la loi.

Art. 19.

Tout professionnel doit veiller à la protection contre toute indiscrétion du dossier, ainsi que de tout document de source extérieure, concernant la personne prise en charge, qu’il peut contenir. Lorsque le professionnel de santé l’estime utile, ou lorsque la personne prise en charge lui en fait la demande, il doit remettre à celle-ci les éléments objectifs des documents le concernant.

Art. 20.

Si le professionnel de santé se sert de ses observations et expériences pour des publications et travaux de recherche, il doit faire en sorte que l’identification des personnes prises en charge soit impossible, sauf accord écrit préalable.

Art. 21.

En règle générale, la diffusion dans le cadre de l’exercice professionnel des informations concernant une personne prise en charge n’est légitime que dans l’intérêt de cette personne et avec son accord écrit. Ainsi, le professionnel de santé assure rapidement la transmission des informations à ceux qui le relaient dans la prise en charge d’une personne. Il veille à la protection contre toute indiscrétion des informations transmises et prend les précautions requises pour éviter que des personnes non autorisées puissent y avoir accès.

Chapitre III.

Devoirs des professionnels de santé entre eux

Art. 22.

Est interdit tout compérage entre professionnels de santé et médecins, pharmaciens, responsables de laboratoires d’analyses médicales, d’établissements de fabrication ou de vente de remèdes, d’appareils, de matériels ou de produits nécessaires à l’exercice d’une profession de santé, ainsi qu’entre professionnels de santé et responsables d’établissements de soins, d’établissements médico-sociaux ou sociaux ou toutes autres personnes.

Art. 23.

Tout procédé de concurrence déloyale et notamment tout détournement de clientèle prise en charge sont interdits. Le professionnel de santé ne doit pas s’attribuer les mérites d’un confrère.

Art. 24.

Les professionnels de santé veillent à entretenir entre eux et avec l’ensemble de l’équipe multidisciplinaire des relations professionnelles et des rapports de collaboration efficaces et de bonne confraternité. Un professionnel de santé qui a un différend avec un confrère peut rechercher une conciliation par l’intermédiaire des associations professionnelles ou, le cas échéant, par l’intermédiaire de son employeur ou au besoin par l’intermédiaire du Conseil supérieur de certaines professions de santé.

Art. 25.

Lorsque, dans le cadre du travail en équipe, le professionnel de santé délègue des responsabilités, il évalue avec un esprit critique sa propre compétence et celle de ses collègues.

Art. 26.

Le professionnel de santé, chargé d’un rôle de coordination et d’encadrement, veille à la bonne exécution des actes accomplis par les autres professionnels de santé ainsi que des élèves en voie de formation. Il contrôle et surveille les activités qu’il ordonne en bonne et due forme à ses collaborateurs dans les limites des attributions et de l’expérience professionnelle de ceux-ci.

Art. 27.

Si le professionnel de santé constate un manque de compétence ou une conduite contraire à l’éthique professionnelle auprès de ses confrères ou autres professionnels de santé, il est avant tout tenu de veiller au bien-être et à la sécurité des personnes prises en charge. Après avoir établi les faits et lorsque les risques pour les personnes prises en charge ne sont pas imminents, le professionnel de santé doit essayer de régulariser la situation en cherchant la discussion et en avertissant le(s) professionnel(s) concerné(s) ou, le cas échéant, son employeur. Lorsqu’au contraire cette première intervention resterait infructueuse, le professionnel de santé doit utiliser, le cas échéant, les procédures établies pour rapporter des incidents ou les risques d’incompétence ou de violation des règles déontologiques.

Chapitre IV.

Devoirs des professionnels de santé envers les organismes employeurs ou ordonnateurs et le corps médical

Art. 28.

Le professionnel de santé applique et respecte les prescriptions médicales, les protocoles et plans de prise en charge valides et pertinents, établis en bonne et due forme et selon les règles de l’art. Il demande à l’ordonnateur ou au médecin prescripteur des compléments d’information chaque fois qu’il le juge nécessaire.

Art. 29.

En cas d’impossibilité ou de refus de dispenser les actes et techniques professionnels requis ou de les prester selon les règles de l’art, le professionnel de santé prévient, dans les meilleurs délais et en fonction de la situation rencontrée, l’ordonnateur et/ou son supérieur hiérarchique. Pour autant que nécessaire, il organise la continuité de la prise en charge. Cette situation est documentée au dossier de la personne prise en charge et le cas échéant, donne lieu à un rapport circonstancié.

Chapitre V.

Devoirs des professionnels de santé en milieu libéral

Art. 30.

Le professionnel de santé doit s’équiper d’une installation adaptée et de moyens techniques suffisants pour assurer le déroulement correct des prestations ainsi que la sécurité de la personne prise en charge.

Art. 31.

A sa demande, le professionnel de santé informe la personne prise en charge du tarif des prestations dispensées au début du traitement. Sont interdits toute fixation de forfait d’honoraires ainsi que toute fraude, abus de cotation ou indication inexacte portant sur les actes effectués.

Art. 32.

Le professionnel de santé s’interdit d’abaisser ses honoraires par rapport aux tarifs officiels de quelque façon que ce soit ou dans un intérêt de concurrence. Est considéré également comme rabais le fait de renoncer aux frais de déplacement lors d’une visite à domicile. Le professionnel de santé est toutefois libre de prester des actes gratuitement.

Art. 33.

Si le professionnel de santé se dégage de la prise en charge du patient, il doit lui expliquer les raisons et transmettre au professionnel de santé désigné par celui-ci toutes les informations utiles à la poursuite de la prise en charge.

Art. 34.

Dans le cadre d’une association entre professionnels de santé, ceux-ci veillent à respecter l’indépendance professionnelle de chacun d’eux.

Art. 35.

Il est interdit à un professionnel de santé qui remplit un mandat électif ou une fonction administrative d’en user activement pour accroître sa clientèle.

Art. 36.

Le professionnel de santé doit exercer sa profession dans un local aménagé à cet effet.

Il est interdit au professionnel de santé d’exercer sa profession dans un local commercial ainsi que dans tout local respectivement dans les dépendances d’un local où sont mis en vente des médicaments, des appareils ou produits ayant un rapport avec son activité professionnelle.

Art. 37.

Les professions de santé ne doivent pas être pratiquées comme un commerce. Tous les procédés directs ou indirects de publicité sont interdits aux professionnels de santé.

Art. 38.

Sont prohibées les annonces ou déclarations décrivant, même objectivement, le professionnel de santé, ses activités professionnelles, sa clientèle, ses spécialités, ses mérites et succès scientifiques et professionnels, le tout sous réserve des articles 39 et 40.

Art. 39.

Les professionnels de santé nouvellement établis ou réétablis sont autorisés à publier, endéans deux mois, dans les quotidiens de leur choix, édités à Luxembourg, une seule annonce par quotidien, contenant comme seules indications leurs nom, titre professionnel, titre de formation, ainsi que l’adresse professionnelle et les coordonnées de télécommunication, y compris, le cas échéant, celles de l’association dont ils font partie en qualité d’associé.

Pour les jeunes professionnels de santé nouvellement établis ou réétablis, le nom du patron de stage ne peut figurer dans une annonce visée à l’alinéa précédent, à moins qu’ils ne fassent partie d’une association.

Les professionnels de santé sont autorisés à publier le déplacement de leur cabinet d’une adresse professionnelle à une autre, avec indication de leurs coordonnées nouvelles et, le cas échéant, de l’association dont ils vont nouvellement faire partie.

Art. 40.

Les seules indications qu’un professionnel de santé ou une association de professionnels de santé sont autorisés à faire figurer dans les annuaires ou répertoires à usage du public, quel qu’en soit le support, sont:

1) ses nom, prénoms, adresse professionnelle, coordonnées de télécommunication, jours et heures de consultations;
2) le titre professionnel correspondant à la profession et son titre de formation selon les dispositions de l’article 5 de la loi modifiée du 26 mars 1992 sur l’exercice et la revalorisation de certaines professions de santé.

Ces insertions doivent répondre à la forme et au format généraux utilisés par ces annuaires et ne pas figurer dans des encadrements ou emplacements spéciaux. L’insertion dans des annuaires ou répertoires qui ne reprennent pas d’office l’ensemble des personnes autorisées à exercer une profession de santé est interdite.

Règlement grand-ducal du 7 octobre 2010 établissant le code de déontologie de certaines professions de santé(94.2 KB)

Source : http://data.legilux.public.lu/eli/etat/leg/rgd/2010/10/07/n4

Declaration of Geneva
Adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948
and amended by the 22nd World Medical Assembly, Sydney, Australia, August 1968
and the 35th World Medical Assembly, Venice, Italy, October 1983
and the 46th WMA General Assembly, Stockholm, Sweden, September 1994
and editorially revised by the 170th WMA Council Session, Divonne-les-Bains, France, May 2005
and the 173rd WMA Council Session, Divonne-les-Bains, France, May 2006
and amended by the 68th WMA General Assembly, Chicago, United States, October 2017




The Physician’s Pledge


AS A MEMBER OF THE MEDICAL PROFESSION:

I SOLEMNLY PLEDGE to dedicate my life to the service of humanity;

THE HEALTH AND WELL-BEING OF MY PATIENT will be my first consideration;

I WILL RESPECT the autonomy and dignity of my patient;

I WILL MAINTAIN the utmost respect for human life;

I WILL NOT PERMIT considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, social standing or any other factor to intervene between my duty and my patient;

I WILL RESPECT the secrets that are confided in me, even after the patient has died;

I WILL PRACTISE my profession with conscience and dignity and in accordance with good medical practice;

I WILL FOSTER the honour and noble traditions of the medical profession;

I WILL GIVE to my teachers, colleagues, and students the respect and gratitude that is their due;

I WILL SHARE my medical knowledge for the benefit of the patient and the advancement of healthcare;

I WILL ATTEND TO my own health, well-being, and abilities in order to provide care of the highest standard;

I WILL NOT USE my medical knowledge to violate human rights and civil liberties, even under threat;

I MAKE THESE PROMISES solemnly, freely, and upon my honour.



Source : https://www.wma.net/policies-post/wma-declaration-of-geneva/



 Deklaration_von_Genf_DE_2017.pdf (35 KiB)
Declaration of Helsinki

Extract from the AMM website :

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants

Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964
and amended by the:
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added)
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)
59th WMA General Assembly, Seoul, Republic of Korea, October 2008
64th WMA General Assembly, Fortaleza, Brazil, October 2013
and by the 75th WMA General Assembly, Helsinki, Finland, October 2024


PREAMBLE

  1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human participants, including research using identifiable human material or data.

    The Declaration is intended to be read as a whole, and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
  1. While the Declaration is adopted by physicians, the WMA holds that these principles should be upheld by all individuals, teams, and organizations involved in medical research, as these principles are fundamental to respect for and protection of all research participants, including both patients and healthy volunteers.


GENERAL PRINCIPLES

  1. The WMA Declaration of Geneva binds the physician with the words, “The health and well-being of my patient will be my first consideration,” and the WMA International Code of Medical Ethics declares “The physician must commit to the primacy of patient health and well-being and must offer care in the patient’s best interest.”
  1. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
  1. Medical progress is based on research that ultimately must include participants.

    Even well-proven interventions should be evaluated continually through research for their safety, effectiveness, efficiency, accessibility, and quality.
  1. Medical research involving human participants is subject to ethical standards that promote and ensure respect for all participants and protect their health and rights.

    Since medical research takes place in the context of various structural inequities, researchers should carefully consider how the benefits, risks, and burdens are distributed.

    Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research. Researchers should enable potential and enrolled participants and their communities to share their priorities and values; to participate in research design, implementation, and other relevant activities; and to engage in understanding and disseminating results.
  1. The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, development and effects of diseases; improve preventive, diagnostic and therapeutic interventions; and ultimately to advance individual and public health.

    These purposes can never take precedence over the rights and interests of individual research participants.
  1. While new knowledge and interventions may be urgently needed during public health emergencies, it remains essential to uphold the ethical principles in this Declaration during such emergencies.
  1. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, autonomy, privacy, and confidentiality of personal information of research participants. The responsibility for the protection of research participants must always rest with physicians or other researchers and never with the research participants, even though they have given consent.
  1. Physicians and other researchers must consider the ethical, legal and regulatory norms and standards for research involving human participants in the country or countries in which the research originated and where it is to be performed, as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research participants set forth in this Declaration.
  1. Medical research should be designed and conducted in a manner that avoids or minimizes harm to the environment and strives for environmental sustainability.
  1. Medical research involving human participants must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Such research requires the supervision of a competent and appropriately qualified physician or other researcher.

    Scientific integrity is essential in the conduct of medical research involving human participants. Involved individuals, teams, and organizations must never engage in research misconduct.
  1. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
  1. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research will not adversely affect the health of the patients who serve as research participants.
  1. Appropriate compensation and treatment for participants who are harmed as a result of participating in research must be ensured.

Risks, Burdens, and Benefits

  1. In medical practice and in medical research, most interventions involve risks and burdens.
    Medical research involving human participants may only be conducted if the importance of the objective outweighs the risks and burdens to the research participants.
  1. All medical research involving human participants must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.>Measures to minimize the risks and burdens must be implemented. The risks and burdens must be continuously monitored, assessed, and documented by the researcher.
  1. Physicians and other researchers may not engage in research involving human participants unless they are confident that the risks and burdens have been adequately assessed and can be satisfactorily managed.

    When the risks and burdens are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians and other researchers must assess whether to continue, modify or immediately stop the research.


Individual, Group, and Community Vulnerability

  1. Some individuals, groups, and communities are in a situation of more vulnerability as research participants due to factors that may be fixed or contextual and dynamic, and thus are at greater risk of being wronged or incurring harm. When such individuals, groups, and communities have distinctive health needs, their exclusion from medical research can potentially perpetuate or exacerbate their disparities. Therefore, the harms of exclusion must be considered and weighed against the harms of inclusion. In order to be fairly and responsibly included in research, they should receive specifically considered support and protections.
  1. Medical research with individuals, groups, or communities in situations of particular vulnerability is only justified if it is responsive to their health needs and priorities and the individual, group, or community stands to benefit from the resulting knowledge, practices, or interventions. Researchers should only include those in situations of particular vulnerability when the research cannot be carried out in a less vulnerable group or community, or when excluding them would perpetuate or exacerbate their disparities.

Scientific Requirements and Research Protocols

  1. Medical research involving human participants must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid, and valuable knowledge and avoid research waste. The research must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.

    The welfare of animals used for research must be respected.
  1. The design and performance of all medical research involving human participants must be clearly described and justified in a research protocol.

    The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research.

    In clinical trials, the protocol must also describe any post-trial provisions.


Research Ethics Committees

  1. The protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the research This committee must be transparent in its functioning and must have the independence and authority to resist undue influence from the researcher, the sponsor, or others. The committee must have sufficient resources to fulfill its duties, and its members and staff must collectively have adequate education, training, qualifications, and diversity to effectively evaluate each type of research it reviews.

    The committee must have sufficient familiarity with local circumstances and context, and include at least one member of the general public. It must take into consideration the ethical, legal, and regulatory norms and standards of the country or countries in which the research is to be performed as well as applicable international norms and standards, but these must not be allowed to reduce or eliminate any of the protections for research participants set forth in this Declaration.

    When collaborative research is performed internationally, the research protocol must be approved by research ethics committees in both the sponsoring and host countries.

    The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research. Where monitoring is required, the researcher must provide information to the committee and/or competent data and safety monitoring entity, especially about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the research, the researchers must submit a final report to the committee containing a summary of the findings and conclusions.


Privacy and Confidentiality

  1. Every precaution must be taken to protect the privacy of research participants and the confidentiality of their personal information.

Free and Informed Consent

  1. Free and informed consent is an essential component of respect for individual autonomy. Participation by individuals capable of giving informed consent in medical research must be voluntary. Although it may be appropriate to consult family members or community representatives, individuals capable of giving informed consent may not be enrolled in research unless they freely agree.
  1. In medical research involving human participants capable of giving informed consent, each potential participant must be adequately informed in plain language of the aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research.

    The potential participant must be informed of the right to refuse to participate in the research or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information and communication needs of individual potential participants as well as to the methods used to deliver the information.

    After ensuring that the potential participant has understood the information, the physician or another qualified individual must then seek the potential participant’s freely given informed consent, formally documented on paper or electronically. If the consent cannot be expressed on paper or electronically, the non-written consent must be formally witnessed and documented.

    All medical research participants should be given the option of being informed about the general outcome and results of the research.
  1. When seeking informed consent for participation in research the physician or other researcher must be particularly cautious if the potential participant is in a dependent relationship with them or may consent under duress. In such situations, the informed consent must be sought by an appropriately qualified individual who is independent of this relationship.
  1. In medical research involving human participants incapable of giving free and informed consent, the physician or other qualified individual must seek informed consent from the legally authorized representative, considering preferences and values expressed by the potential participant.

    Those persons incapable of giving free and informed consent are in situations of particular vulnerability and are entitled to the corresponding safeguards. In addition to receiving the protections for the particularly vulnerable, those incapable of giving consent must only be included if the research is likely to either personally benefit them or if it entails only minimal risk and minimal burden.
  1. When a potential research participant who is incapable of giving free and informed consent is able to give assent to decisions about participation in research, the physician or other qualified individual must seek that assent in addition to the consent of the legally authorized representative, considering any preferences and values expressed by the potential participant. The potential participant’s dissent should be respected.
  1. Research involving participants who are physically or mentally incapable of giving consent (for example, unconscious patients) may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician or other qualified individual must seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the research may proceed without informed consent provided that the specific reasons for involving participants with a condition that renders them unable to give informed consent have been stated in the research protocol and the research has been approved by a research ethics committee.

    Free and informed consent to remain in the research must be obtained as soon as possible from a legally authorized representative or, if they regain capacity to give consent, from the participant.
  1. The physician or other researcher must fully inform potential participants which aspects of their care are related to the research. The refusal of a patient to participate in research or the patient’s decision to withdraw from research must never adversely affect the patient-physician relationship or provision of the standard of care.
  1. Physicians or other qualified individuals must obtain free and informed consent from research participants for the collection, processing, storage, and foreseeable secondary use of biological material and identifiable or re-identifiable data. Any collection and storage of data or biological material from research participants for multiple and indefinite uses should be consistent with requirements set forth in the WMA Declaration of Taipei, including the rights of individuals and the principles of governance. A research ethics committee must approve the establishment and monitor ongoing use of such databases and biobanks.

    Where consent is impossible or impracticable to obtain, secondary research on stored data or biological material may be done only after consideration and approval of a research ethics committee.


Use of Placebo

  1. The benefits, risks, burdens, and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

      • If no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
      • If for compelling and scientifically sound methodological reasons the use of any intervention other than the best proven one(s), the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention; and the participants who receive any intervention other than the best proven one(s), placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.


      • Extreme care must be taken to avoid abuse of this option.


Post-Trial Provisions

  1. In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to be provided by themselves, healthcare systems, or governments for all participants who still need an intervention identified as beneficial and reasonably safe in the trial. Exceptions to this requirement must be approved by a research ethics committee. Specific information about post-trial provisions must be disclosed to participants as part of informed consent.

Research Registration, Publication, and Dissemination of Results

  1. Medical research involving human participants must be registered in a publicly accessible database before recruitment of the first participant.
  1. Researchers, authors, sponsors, editors, and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human participants and are accountable for the timeliness, completeness, and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations, and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

  1. When an unproven intervention is utilized in an attempt to restore health or alleviate suffering for an individual patient because approved options are inadequate or ineffective and enrollment in a clinical trial is not possible, it should subsequently be made the object of research designed to evaluate safety and efficacy. Physicians participating in such interventions must first seek expert advice, weigh possible risks, burdens, and benefits, and obtain informed consent. They must also record and share data when appropriate and avoid compromising clinical trials. These interventions must never be undertaken to circumvent the protections for research participants set forth in this Declaration.

Source: www.wma.net

Declaration of Lisbon

Extract from the AMM website :

Adopted by the 34th World Medical Assembly, Lisbon, Portugal, September/October 1981
and amended by the 47th WMA General Assembly, Bali, Indonesia, September 1995
and editorially revised by the 171st WMA Council Session, Santiago, Chile, October 2005
and reaffirmed by the 200th WMA Council Session, Oslo, Norway, April 2015


PREAMBLE

The relationship between physicians, their patients and broader society has undergone significant changes in recent times. While a physician should always act according to his/her conscience, and always in the best interests of the patient, equal effort must be made to guarantee patient autonomy and justice. The following Declaration represents some of the principal rights of the patient that the medical profession endorses and promotes. Physicians and other persons or bodies involved in the provision of health care have a joint responsibility to recognize and uphold these rights. Whenever legislation, government action or any other administration or institution denies patients these rights, physicians should pursue appropriate means to assure or to restore them.


PRINCIPLES

  1. Right to medical care of good quality
    1. Every person is entitled without discrimination to appropriate medical care.
    2. Every patient has the right to be cared for by a physician whom he/she knows to be free to make clinical and ethical judgements without any outside interference.
    3. The patient shall always be treated in accordance with his/her best interests. The treatment applied shall be in accordance with generally approved medical principles.
    4. Quality assurance should always be a part of health care. Physicians, in particular, should accept responsibility for being guardians of the quality of medical services.
    5. In circumstances where a choice must be made between potential patients for a particular treatment that is in limited supply, all such patients are entitled to a fair selection procedure for that treatment. That choice must be based on medical criteria and made without discrimination.
    6. The patient has the right to continuity of health care. The physician has an obligation to cooperate in the coordination of medically indicated care with other health care providers treating the patient. The physician may not discontinue treatment of a patient as long as further treatment is medically indicated, without giving the patient reasonable assistance and sufficient opportunity to make alternative arrangements for care.
  2. Right to freedom of choice
    1. The patient has the right to choose freely and change his/her physician and hospital or health service institution, regardless of whether they are based in the private or public sector.
    2. The patient has the right to ask for the opinion of another physician at any stage.
  3. Right to self-determination
    1. The patient has the right to self-determination, to make free decisions regarding himself/herself. The physician will inform the patient of the consequences of his/her decisions.
    2. A mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy. The patient has the right to the information necessary to make his/her decisions. The patient should understand clearly what is the purpose of any test or treatment, what the results would imply, and what would be the implications of withholding consent.
    3. The patient has the right to refuse to participate in research or the teaching of medicine.
  4. The unconscious patient
    1. If the patient is unconscious or otherwise unable to express his/her will, informed consent must be obtained whenever possible, from a legally entitled representative.
    2. If a legally entitled representative is not available, but a medical intervention is urgently needed, consent of the patient may be presumed, unless it is obvious and beyond any doubt on the basis of the patient’s previous firm expression or conviction that he/she would refuse consent to the intervention in that situation.
    3. However, physicians should always try to save the life of a patient unconscious due to a suicide attempt.
  5. The legally incompetent patient
    1. If a patient is a minor or otherwise legally incompetent, the consent of a legally entitled representative is required in some jurisdictions. Nevertheless the patient must be involved in the decision-making to the fullest extent allowed by his/her capacity.
    2. If the legally incompetent patient can make rational decisions, his/her decisions must be respected, and he/she has the right to forbid the disclosure of information to his/her legally entitled representative.
    3. If the patient’s legally entitled representative, or a person authorized by the patient, forbids treatment which is, in the opinion of the physician, in the patient’s best interest, the physician should challenge this decision in the relevant legal or other institution. In case of emergency, the physician will act in the patient’s best interest.
  6. Procedures against the patient’s will
    1. Diagnostic procedures or treatment against the patient’s will can be carried out only in exceptional cases, if specifically permitted by law and conforming to the principles of medical ethics.
  7. Right to information
    1. The patient has the right to receive information about himself/herself recorded in any of his/her medical records, and to be fully informed about his/her health status including the medical facts about his/her condition. However, confidential information in the patient’s records about a third party should not be given to the patient without the consent of that third party.
    2. Exceptionally, information may be withheld from the patient when there is good reason to believe that this information would create a serious hazard to his/her life or health.
    3. Information should be given in a way appropriate to the patient’s culture and in such a way that the patient can understand.
    4. The patient has the right not to be informed on his/her explicit request, unless required for the protection of another person’s life.
    5. The patient has the right to choose who, if anyone, should be informed on his/her behalf.
  8. Right to confidentiality
    1. All identifiable information about a patient’s health status, medical condition, diagnosis, prognosis and treatment and all other information of a personal kind must be kept confidential, even after death. Exceptionally, descendants may have a right of access to information that would inform them of their health risks.
    2. Confidential information can only be disclosed if the patient gives explicit consent or if expressly provided for in the law. Information can be disclosed to other health care providers only on a strictly “need to know” basis unless the patient has given explicit consent.
    3. All identifiable patient data must be protected. The protection of the data must be appropriate to the manner of its storage. Human substances from which identifiable data can be derived must be likewise protected.
  9. Right to Health Education
    1. Every person has the right to health education that will assist him/her in making informed choices about personal health and about the available health services. The education should include information about healthy lifestyles and about methods of prevention and early detection of illnesses. The personal responsibility of everybody for his/her own health should be stressed. Physicians have an obligation to participate actively in educational efforts.
  10. Right to dignity
    1. The patient’s dignity and right to privacy shall be respected at all times in medical care and teaching, as shall his/her culture and values.
    2. The patient is entitled to relief of his/her suffering according to the current state of knowledge.
    3. The patient is entitled to humane terminal care and to be provided with all available assistance in making dying as dignified and comfortable as possible.
  11. Right to religious assistance
    1. The patient has the right to receive or to decline spiritual and moral comfort including the help of a minister of his/her chosen religion.

Source : www.wma.net