{"id":9633,"date":"2017-11-23T16:17:03","date_gmt":"2017-11-23T16:17:03","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Jun1964.pdf"},"modified":"2017-11-23T16:17:03","modified_gmt":"2017-11-23T16:17:03","slug":"doh-jun1964-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/ce-que-nous-faisons\/ethique\/declaration-dhelsinki\/doh-jun1964-2\/","title":{"rendered":"DoH-Jun1964"},"author":5,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

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

DECLARATION OF HELSINKI
\nRecommendations guiding doctors
\nin clinical research
\nAdopted by the 18th
\nWorld Medical Assembly, Helsinki, Finland, June 1964
\nINTRODUCTION
\nIt is the mission of the doctor to safeguard the health of the people. His knowledge and
\nconscience are dedicated to the fulfilment of this mission.
\nThe Declaration of Geneva of The World Medical Association binds the doctor with the words:
\n\u00ab\u00a0The health of my patient will be my first consideration\u00a0\u00bb and the International Code of Medical
\nEthics declares that \u00ab\u00a0Any act or advice which could weaken physical or mental resistance of a
\nhuman being may be used only in his interest.\u00a0\u00bb
\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 each doctor in clinical research. It
\nmust be stressed that the standards as drafted are only a guide to physicians all over the world.
\nDoctors are not relieved from criminal, civil and ethical responsibilities under the laws of their
\nown countries.
\nIn the field of clinical research a fundamental distinction must be recognized between clinical
\nresearch in which the aim is essentially therapeutic for a patient, and the clinical research, the
\nessential object of which is purely scientific and without therapeutic value to the person
\nsubjected to the research.
\nI. BASIC PRINCIPLES
\n1. Clinical research must conform to the moral and scientific principles that justify medical
\nresearch and should be based on laboratory and animal experiments or other scientifically
\nestablished facts.
\n2. Clinical research should be conducted only by scientifically qualified persons and under
\nthe supervision of a qualified medical man.
\n3. Clinical research cannot legitimately be carried out unless the importance of the objective
\nis in proportion to the inherent risk to the subject.
\n4. Every clinical research project should be preceded by careful assessment of inherent risks
\nin comparison to foreseeable benefits to the subject or to others.
\n5. Special caution should be exercised by the doctor in performing clinical research in which
\nthe personality of the subject is liable to be altered by drugs or experimental procedure.
\n2
\nII. CLINICAL RESEARCH COMBINED WITH PROFESSIONAL CARE
\n1. In the treatment of the sick person, the doctor must be free to use a new therapeutic
\nmeasure, if in his judgment it offers hope of saving life, reestablishing health, or alleviating
\nsuffering.
\nIf at all possible, consistent with patient psychology, the doctor should obtain the patient\u2019s
\nfreely given consent after the patient has been given a full explanation. In case of legal
\nincapacity, consent should also be procured from the legal guardian; in case of physical
\nincapacity the permission of the legal guardian replaces that of the patient.
\n2. The doctor can combine clinical research with professional care, the objective being the
\nacquisition of new medical knowledge, only to the extent that clinical research is justified
\nby its therapeutic value for the patient.
\nIII. NON-THERAPEUTIC CLINICAL RESEARCH
\n1. In the purely scientific application of clinical research carried out on a human being, it is
\nthe duty of the doctor to remain the protector of the life and health of that person on whom
\nclinical research is being carried out.
\n2. The nature, the purpose and the risk of clinical research must be explained to the subject by
\nthe doctor.
\n3a. Clinical research on a human being cannot be undertaken without his free consent after he
\nhas been informed; if he is legally incompetent, the consent of the legal guardian should be
\nprocured.
\n3b. The subject of clinical research should be in such a mental, physical and legal state as to be
\nable to exercise fully his power of choice.
\n3c. Consent should, as a rule, be obtained in writing. However, the responsibility for clinical
\nresearch always remains with the research worker; it never falls on the subject even after
\nconsent is obtained.
\n4a. The investigator must respect the right of each individual to safeguard his personal
\nintegrity, especially if the subject is in a dependent relationship to the investigator.
\n4b. At any time during the course of clinical research the subject or his guardian should be free
\nto withdraw permission for research to be continued.
\nThe investigator or the investigating team should discontinue the research if in his or their
\njudgement, it may, if continued, be harmful to the individual.
\n\uf0a7 \uf0a7 \uf0a7<\/p>\n"},"caption":{"rendered":"

DECLARATION OF HELSINKI Recommendations guiding doctors in clinical research Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 INTRODUCTION It is the mission of the doctor to safeguard the health of the people. His knowledge and conscience are dedicated to the fulfilment of this mission. The Declaration of Geneva of The World Medical […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{"sizes":{"thumbnail":{"file":"DoH-Jun1964-pdf-106x150.jpg","width":106,"height":150,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Jun1964-pdf-106x150.jpg"},"medium":{"file":"DoH-Jun1964-pdf-212x300.jpg","width":212,"height":300,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Jun1964-pdf-212x300.jpg"},"large":{"file":"DoH-Jun1964-pdf-724x1024.jpg","width":724,"height":1024,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Jun1964-pdf-724x1024.jpg"},"full":{"file":"DoH-Jun1964-pdf.jpg","width":1058,"height":1497,"mime_type":"application\/pdf","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Jun1964-pdf.jpg"}}},"post":628,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Jun1964.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/9633"}],"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=9633"}]}}