{"id":9639,"date":"2017-11-23T16:17:07","date_gmt":"2017-11-23T16:17:07","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1983.pdf"},"modified":"2017-11-23T16:17:07","modified_gmt":"2017-11-23T16:17:07","slug":"doh-oct1983-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/ce-que-nous-faisons\/ethique\/declaration-dhelsinki\/doh-oct1983-2\/","title":{"rendered":"DoH-Oct1983"},"author":5,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

\"\"<\/a><\/p>\n

November 1983 17.C
\nOriginal: English
\nDECLARATION OF HELSINKI
\nRecommendations guiding physicians
\nin biomedical research involving human subjects
\nAdopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964
\nand amended by the
\n29th World Medical Assembly, Tokyo, Japan, October 1975
\n35th World Medical Assembly, Venice, Italy, October 1983
\nINTRODUCTION
\nIt is the mission of the physician to safeguard the health of the people. His or her knowledge and
\nconscience are dedicated to the fulfillment of this mission.
\nThe Declaration of Geneva of the World Medical Association binds the physician with the
\nwords: \u00ab\u00a0The health of my patient will be my first consideration,\u00a0\u00bb and the International Code of
\nMedical Ethics declares that, \u00ab\u00a0A physician shall act only in the patient’s interest when providing
\nmedical care which might have the effect of weakening the physical and mental condition of the
\npatient.\u00a0\u00bb
\nThe purpose of biomedical research involving human subjects must be to improve diagnostic,
\ntherapeutic and prophylactic procedures and the understanding of the aetiology and
\npathogenesis of disease.
\nIn current medical practice most diagnostic, therapeutic or prophylactic procedures involve
\nhazards. This applies especially to biomedical research.
\nMedical progress is based on research which ultimately must rest in part on experimentation
\ninvolving human subjects.
\nIn the field of biomedical research a fundamental distinction must be recognized between
\nmedical research in which the aim is essentially diagnostic or therapeutic for a patient, and
\nmedical research, the essential object of which is purely scientific and without implying direct
\ndiagnostic or therapeutic value to the person subjected to the research.
\nSpecial caution must be exercised in the conduct of research which may affect the environment,
\nand the welfare of animals used for research must be respected.
\nBecause it is essential that the results of laboratory experiments be applied to human beings to
\nfurther scientific knowledge and to help suffering humanity, the World Medical Association
\nhas prepared the following recommendations as a guide to every physician in biomedical
\nresearch involving human subjects. They should be kept under review in the future. It must be
\nstressed that the standards as drafted are only a guide to physicians all over the world.
\n2 17.C
\nPhysicians are not relieved from criminal, civil and ethical responsibilities under the laws of
\ntheir own countries.
\nI. BASIC PRINCIPLES
\n1. Biomedical research involving human subjects must conform to generally accepted
\nscientific principles and should be based on adequately performed laboratory and animal
\nexperimentation and on a thorough knowledge of the scientific literature.
\n2. The design and performance of each experimental procedure involving human subjects
\nshould be clearly formulated in an experimental protocol which should be transmitted to a
\nspecially appointed independent committee for consideration, comment and guidance.
\n3. Biomedical research involving human subjects should be conducted only by scientifically
\nqualified persons and under the supervision of a clinically competent medical person. The
\nresponsibility for the human subject must always rest with a medically qualified person
\nand never rest on the subject of the research, even though the subject has given his or her
\nconsent.
\n4. Biomedical research involving human subjects cannot legitimately be carried out unless
\nthe importance of the objective is in proportion to the inherent risk to the subject.
\n5. Every biomedical research project involving human subjects should be preceded by
\ncareful assessment of predictable risks in comparison with foreseeable benefits to the
\nsubject or to others. Concern for the interests of the subject must always prevail over the
\ninterests of science and society.
\n6. The right of the research subject to safeguard his or her integrity must always be
\nrespected. Every precaution should be taken to respect the privacy of the subject and to
\nminimize the impact of the study on the subject’s physical and mental integrity and on the
\npersonality of the subject.
\n7. Physicians should abstain from engaging in research projects involving human subjects
\nunless they are satisfied that the hazards involved are believed to be predictable.
\nPhysicians should cease any investigation if the hazards are found to outweigh the
\npotential benefits.
\n8. In publication of the results of his or her research, the physician is obliged to preserve the
\naccuracy of the results. Reports of experimentation not in accordance with the principles
\nlaid down in this Declaration should not be accepted for publication.
\n9. In any research on human beings, each potential subject must be adequately informed of
\nthe aims, methods, anticipated benefits and potential hazards of the study and the
\ndiscomfort it may entail. He or she should be informed that he or she is at liberty to
\nabstain from participation in the study and that he or she is free to withdraw his or her
\nconsent to participation at any time. The physician should then obtain the subject’s
\nfreely-given informed consent, preferably in writing.
\n3 17.C
\n10. When obtaining informed consent for the research project the physician should be
\nparticularly cautious if the subject is in a dependent relationship to him or her or may
\nconsent under duress. In that case the informed consent should be obtained by a physician
\nwho is not engaged in the investigation and who is completely independent of this official
\nrelationship.
\n11. In case of legal incompetence, informed consent should be obtained from the legal
\nguardian in accordance with national legislation. Where physical or mental incapacity
\nmakes it impossible to obtain informed consent, or when the subject is a minor,
\npermission from the responsible relative replaces that of the subject in accordance with
\nnational legislation.
\nWhenever the minor child is in fact able to give a consent, the minor’s consent must be
\nobtained in addition to the consent of the minor’s legal guardian.
\n12. The research protocol should always contain a statement of the ethical considerations
\ninvolved and should indicate that the principles enunciated in the present Declaration are
\ncomplied with.
\nII. MEDICAL RESEARCH COMBINED WITH PROFESSIONAL CARE
\n(Clinical Research)
\n1. In the treatment of the sick person, the physician must be free to use a new diagnostic and
\ntherapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing
\nhealth or alleviating suffering.
\n2. The potential benefits, hazards and discomfort of a new method should be weighed
\nagainst the advantages of the best current diagnostic and therapeutic methods.
\n3. In any medical study, every patient – including those of a control group, if any – should be
\nassured of the best proven diagnostic and therapeutic method.
\n4. The refusal of the patient to participate in a study must never interfere with the
\nphysician-patient relationship.
\n5. If the physician considers it essential not to obtain informed consent, the specific reasons
\nfor this proposal should be stated in the experimental protocol for transmission to the
\nindependent committee (I, 2).
\n6. The physician can combine medical research with professional care, the objective being
\nthe acquisition of new medical knowledge, only to the extent that medical research is
\njustified by its potential diagnostic or therapeutic value for the patient.
\nIII. NON-THERAPEUTIC BIOMEDICAL RESEARCH INVOLVING HUMAN
\nSUBJECTS (Non-Clinical Biomedical Research)
\n1. In the purely scientific application of medical research carried out on a human being, it is
\nthe duty of the physician to remain the protector of the life and health of that person on
\nwhom biomedical research is being carried out.
\n4 17.C
\n2. The subjects should be volunteers – either healthy persons or patients for whom the
\nexperimental design is not related to the patient’s illness.
\n3. The investigator or the investigating team should discontinue the research if in his\/her or
\ntheir judgment it may, if continued, be harmful to the individual.
\n4. In research on man, the interest of science and society should never take precedence over
\nconsiderations related to the wellbeing of the subject.
\n\uf0a7 \uf0a7 \uf0a7<\/p>\n"},"caption":{"rendered":"

November 1983 17.C Original: English DECLARATION OF HELSINKI Recommendations guiding physicians in biomedical research involving human subjects Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975 35th World Medical Assembly, Venice, Italy, October 1983 INTRODUCTION It is the mission of the […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{"sizes":{"thumbnail":{"file":"DoH-Oct1983-pdf-106x150.jpg","width":106,"height":150,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1983-pdf-106x150.jpg"},"medium":{"file":"DoH-Oct1983-pdf-212x300.jpg","width":212,"height":300,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1983-pdf-212x300.jpg"},"large":{"file":"DoH-Oct1983-pdf-724x1024.jpg","width":724,"height":1024,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1983-pdf-724x1024.jpg"},"full":{"file":"DoH-Oct1983-pdf.jpg","width":1058,"height":1497,"mime_type":"application\/pdf","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1983-pdf.jpg"}}},"post":628,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1983.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/9639"}],"collection":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/comments?post=9639"}]}}