{"id":9648,"date":"2017-11-23T16:17:12","date_gmt":"2017-11-23T16:17:12","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2004.pdf"},"modified":"2017-11-23T16:17:12","modified_gmt":"2017-11-23T16:17:12","slug":"doh-oct2004-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/ce-que-nous-faisons\/ethique\/declaration-dhelsinki\/doh-oct2004-2\/","title":{"rendered":"DoH-Oct2004"},"author":5,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

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

1
\nJune 1964 17.C\/04
\nOriginal: English
\nTHE WORLD MEDICAL ASSOCIATION, INC
\nDECLARATION OF HELSINKI
\nEthical Principles for Medical Research Involving Human Subjects
\nAdopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964
\nand amended by the
\n29th WMA General Assembly, Tokyo, Japan, October 1975
\n35th WMA General Assembly, Venice, Italy, October 1983
\n41st WMA General Assembly, Hong Kong, September 1989
\n48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
\nand the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000
\nNote of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002
\nNote of Clarification on Paragraph 30 added by the WMA General Assembly, Tokyo 2004
\nA. INTRODUCTION
\n1. The World Medical Association has developed the Declaration of Helsinki as a statement of
\nethical principles to provide guidance to physicians and other participants in medical
\nresearch involving human subjects. Medical research involving human subjects includes
\nresearch on identifiable human material or identifiable data.
\n2. It is the duty of the physician to promote and safeguard the health of the people. The
\nphysician’s knowledge and conscience are dedicated to the fulfillment of this duty.
\n3. The 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
\nof Medical Ethics declares that, \u00ab\u00a0A physician shall act only in the patient’s interest when
\nproviding medical care which might have the effect of weakening the physical and mental
\ncondition of the patient.\u00a0\u00bb
\n4. Medical progress is based on research which ultimately must rest in part on experimentation
\ninvolving human subjects.
\n5. In medical research on human subjects, considerations related to the well-being of the
\nhuman subject should take precedence over the interests of science and society.
\n6. The primary purpose of medical research involving human subjects is to improve
\nprophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology
\nand pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic
\nmethods must continuously be challenged through research for their effectiveness,
\nefficiency, accessibility and quality.
\nJune 1964 17.C\/04
\n2
\n7. In current medical practice and in medical research, most prophylactic, diagnostic and
\ntherapeutic procedures involve risks and burdens.
\n8. Medical research is subject to ethical standards that promote respect for all human beings
\nand protect their health and rights. Some research populations are vulnerable and need
\nspecial protection. The particular needs of the economically and medically disadvantaged
\nmust be recognized. Special attention is also required for those who cannot give or refuse
\nconsent for themselves, for those who may be subject to giving consent under duress, for
\nthose who will not benefit personally from the research and for those for whom the research
\nis combined with care.
\n9. Research Investigators should be aware of the ethical, legal and regulatory requirements for
\nresearch on human subjects in their own countries as well as applicable international
\nrequirements. No national ethical, legal or regulatory requirement should be allowed to
\nreduce or eliminate any of the protections for human subjects set forth in this Declaration.
\nB. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH
\n1. It is the duty of the physician in medical research to protect the life, health, privacy, and
\ndignity of the human subject.
\n2. Medical research involving human subjects must conform to generally accepted scientific
\nprinciples, be based on a thorough knowledge of the scientific literature, other relevant
\nsources of information, and on adequate laboratory and, where appropriate, animal
\nexperimentation.
\n3. Appropriate caution must be exercised in the conduct of research which may affect the
\nenvironment, and the welfare of animals used for research must be respected.
\n4. The design and performance of each experimental procedure involving human subjects
\nshould be clearly formulated in an experimental protocol. This protocol should be submitted
\nfor consideration, comment, guidance, and where appropriate, approval to a specially
\nappointed ethical review committee, which must be independent of the investigator, the
\nsponsor or any other kind of undue influence. This independent committee should be in
\nconformity with the laws and regulations of the country in which the research experiment is
\nperformed. The committee has the right to monitor ongoing trials. The researcher has the
\nobligation to provide monitoring information to the committee, especially any serious
\nadverse events. The researcher should also submit to the committee, for review, information
\nregarding funding, sponsors, institutional affiliations, other potential conflicts of interest and
\nincentives for subjects.
\n5. The research protocol should always contain a statement of the ethical considerations
\ninvolved and should indicate that there is compliance with the principles enunciated in this
\nDeclaration.
\n6. Medical 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 and
\nnever rest on the subject of the research, even though the subject has given consent.
\nJune 1964 17.C\/04
\n3
\n7. Every medical research project involving human subjects should be preceded by careful
\nassessment of predictable risks and burdens in comparison with foreseeable benefits to the
\nsubject or to others. This does not preclude the participation of healthy volunteers in medical
\nresearch. The design of all studies should be publicly available.
\n8. Physicians should abstain from engaging in research projects involving human subjects
\nunless they are confident that the risks involved have been adequately assessed and can be
\nsatisfactorily managed. Physicians should cease any investigation if the risks are found to
\noutweigh the potential benefits or if there is conclusive proof of positive and beneficial
\nresults.
\n9. Medical research involving human subjects should only be conducted if the importance of
\nthe objective outweighs the inherent risks and burdens to the subject. This is especially
\nimportant when the human subjects are healthy volunteers.
\n10. Medical research is only justified if there is a reasonable likelihood that the populations in
\nwhich the research is carried out stand to benefit from the results of the research.
\n11. The subjects must be volunteers and informed participants in the research project.
\n12. The right of research subjects to safeguard their integrity must always be respected. Every
\nprecaution should be taken to respect the privacy of the subject, the confidentiality of the
\npatient’s information and to minimize the impact of the study on the subject’s physical and
\nmental integrity and on the personality of the subject.
\n13. In any research on human beings, each potential subject must be adequately informed of the
\naims, methods, sources of funding, any possible conflicts of interest, institutional affiliations
\nof the researcher, the anticipated benefits and potential risks of the study and the discomfort
\nit may entail. The subject should be informed of the right to abstain from participation in the
\nstudy or to withdraw consent to participate at any time without reprisal. After ensuring that
\nthe subject has understood the information, the physician should then obtain the subject’s
\nfreely-given informed consent, preferably in writing. If the consent cannot be obtained in
\nwriting, the non-written consent must be formally documented and witnessed.
\n14. When obtaining informed consent for the research project the physician should be
\nparticularly cautious if the subject is in a dependent relationship with the physician or may
\nconsent under duress. In that case the informed consent should be obtained by a
\nwell-informed physician who is not engaged in the investigation and who is completely
\nindependent of this relationship.
\n15. For a research subject who is legally incompetent, physically or mentally incapable of giving
\nconsent or is a legally incompetent minor, the investigator must obtain informed consent
\nfrom the legally authorized representative in accordance with applicable law. These groups
\nshould not be included in research unless the research is necessary to promote the health of
\nthe population represented and this research cannot instead be performed on legally
\ncompetent persons.
\nJune 1964 17.C\/04
\n4
\n16. When a subject deemed legally incompetent, such as a minor child, is able to give assent to
\ndecisions about participation in research, the investigator must obtain that assent in addition
\nto the consent of the legally authorized representative.
\n17. Research on individuals from whom it is not possible to obtain consent, including proxy or
\nadvance consent, should be done only if the physical\/mental condition that prevents
\nobtaining informed consent is a necessary characteristic of the research population. The
\nspecific reasons for involving research subjects with a condition that renders them unable to
\ngive informed consent should be stated in the experimental protocol for consideration and
\napproval of the review committee. The protocol should state that consent to remain in the
\nresearch should be obtained as soon as possible from the individual or a legally authorized
\nsurrogate.
\n18. Both authors and publishers have ethical obligations. In publication of the results of research,
\nthe investigators are obliged to preserve the accuracy of the results. Negative as well as
\npositive results should be published or otherwise publicly available. Sources of funding,
\ninstitutional affiliations and any possible conflicts of interest should be declared in the
\npublication. Reports of experimentation not in accordance with the principles laid down in
\nthis Declaration should not be accepted for publication.
\nC. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH
\nMEDICAL CARE
\n1. The physician may combine medical research with medical care, only to the extent that the
\nresearch is justified by its potential prophylactic, diagnostic or therapeutic value. When
\nmedical research is combined with medical care, additional standards apply to protect the
\npatients who are research subjects.
\n2. The benefits, risks, burdens and effectiveness of a new method should be tested against those
\nof the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude
\nthe use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or
\ntherapeutic method exists.1
\n3. At the conclusion of the study, every patient entered into the study should be assured of
\naccess to the best proven prophylactic, diagnostic and therapeutic methods identified by the
\nstudy.\uf032
\n4. The physician should fully inform the patient which aspects of the care are related to the
\nresearch. The refusal of a patient to participate in a study must never interfere with the
\npatient-physician relationship.
\n5. In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods
\ndo not exist or have been ineffective, the physician, with informed consent from the patient,
\nmust be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in
\nthe physician’s judgement it offers hope of saving life, re-establishing health or alleviating
\nsuffering. Where possible, these measures should be made the object of research, designed
\nto evaluate their safety and efficacy. In all cases, new information should be recorded and,
\nwhere appropriate, published. The other relevant guidelines of this Declaration should be
\nfollowed.
\nJune 1964 17.C\/04
\n5
\n1
\nNote of clarification on paragraph 29 of the WMA Declaration of Helsinki
\nThe WMA hereby reaffirms its position that extreme care must be taken in making use of a
\nplacebo-controlled trial and that in general this methodology should only be used in the absence of
\nexisting proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if
\nproven therapy is available, under the following circumstances:
\n– Where for compelling and scientifically sound methodological reasons its use is necessary to
\ndetermine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or
\n– Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition
\nand the patients who receive placebo will not be subject to any additional risk of serious or
\nirreversible harm.
\nAll other provisions of the Declaration of Helsinki must be adhered to, especially the need for
\nappropriate ethical and scientific review.
\n2
\nNote of clarification on paragraph 30 of the WMA Declaration of Helsinki
\nThe WMA hereby reaffirms its position that it is necessary during the study planning process to
\nidentify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures
\nidentified as beneficial in the study or access to other appropriate care. Post-trial access arrangements
\nor other care must be described in the study protocol so the ethical review committee may consider
\nsuch arrangements during its review.
\n\u2605\u2605\u2605<\/p>\n"},"caption":{"rendered":"

1 June 1964 17.C\/04 Original: English THE WORLD MEDICAL ASSOCIATION, INC DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects 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 […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{"sizes":{"thumbnail":{"file":"DoH-Oct2004-pdf-106x150.jpg","width":106,"height":150,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2004-pdf-106x150.jpg"},"medium":{"file":"DoH-Oct2004-pdf-212x300.jpg","width":212,"height":300,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2004-pdf-212x300.jpg"},"large":{"file":"DoH-Oct2004-pdf-724x1024.jpg","width":724,"height":1024,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2004-pdf-724x1024.jpg"},"full":{"file":"DoH-Oct2004-pdf.jpg","width":1058,"height":1497,"mime_type":"application\/pdf","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2004-pdf.jpg"}}},"post":628,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2004.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/9648"}],"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=9648"}]}}