{"id":9643,"date":"2017-11-23T16:17:08","date_gmt":"2017-11-23T16:17:08","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1996.pdf"},"modified":"2017-11-23T16:17:08","modified_gmt":"2017-11-23T16:17:08","slug":"doh-oct1996-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/que-hacemos\/etica-medica\/declaracion-de-helsinki\/doh-oct1996-2\/","title":{"rendered":"DoH-Oct1996"},"author":5,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

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

October 1996 17.C
\nOriginal: English
\nWORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
\nRecommendations guiding physicians
\nin biomedical research involving human subjects
\nAdopted by the 18th World Medical Assembly
\nHelsinki, Finland, June 1964
\nand amended by the
\n29th World Medical Assembly, Tokyo, Japan, October 1975
\n35th World Medical Assembly, Venice, Italy, October 1983
\n41st World Medical Assembly, Hong Kong, September 1989
\nand the
\n48th General Assembly,Somerset West, Republic of South Africa, October 1996
\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, \u00abThe health of my patient will be my first consideration,\u00bb and the International Code of
\nMedical Ethics declares that, \u00abA 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.\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 has
\nprepared the following recommendations as a guide to every physician in biomedical research
\ninvolving human subjects. They should be kept under review in the future. It must be stressed
\nthat the standards as drafted are only a guide to physicians all over the world. Physicians are not
\nrelieved from criminal, civil and ethical responsibilities under the laws of their own countries.
\n2 17.C
\nI. BASIC PRINCIPLES
\n1. Biomedical research involving human subjects must conform to generally
\naccepted scientific principles and should be based on adequately performed
\nlaboratory and animal experimentation and on a thorough knowledge of the
\nscientific literature.
\n2. The design and performance of each experimental procedure involving human
\nsubjects should be clearly formulated in an experimental protocol which should
\nbe transmitted for consideration, comment and guidance to a specially appointed
\ncommittee independent of the investigator and the sponsor provided that this
\nindependent committee is in conformity with the laws and regulations of the
\ncountry in which the research experiment is performed.
\n3. Biomedical research involving human subjects should be conducted only by
\nscientifically qualified persons and under the supervision of a clinically competent
\nmedical person. The responsibility for the human subject must always rest with a
\nmedically qualified person and never rest on the subject of the research, even
\nthough the subject has given his or her consent.
\n4. Biomedical research involving human subjects cannot legitimately be carried out
\nunless the importance of the objective is in proportion to the inherent risk to the
\nsubject.
\n5. Every biomedical research project involving human subjects should be preceded
\nby careful assessment of predictable risks in comparison with foreseeable benefits
\nto the subject or to others. Concern for the interests of the subject must always
\nprevail over the interests 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
\nand to minimize the impact of the study on the subject’s physical and mental
\nintegrity and on the personality of the subject.
\n7. Physicians should abstain from engaging in research projects involving human
\nsubjects unless they are satisfied that the hazards involved are believed to be
\npredictable. Physicians should cease any investigation if the hazards are found to
\noutweigh the potential benefits.
\n8 In publication of the results of his or her research, the physician is obliged to
\npreserve the accuracy of the results. Reports of experimentation not in accordance
\nwith the principles laid down in this Declaration should not be accepted for
\npublication.
\n9. In any research on human beings, each potential subject must be adequately
\ninformed of the aims, methods, anticipated benefits and potential hazards of the
\nstudy and the discomfort it may entail. He or she should be informed that he or she
\nis at liberty to abstain from participation in the study and that he or she is free to
\nwithdraw his or her consent to participation at any time. The physician should
\nthen obtain the subject’s freely-given informed consent, preferably in writing.
\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
\nmay consent under duress. In that case the informed consent should be obtained by
\na physician who is not engaged in the investigation and who is completely
\nindependent of this official relationship.
\n11. In case of legal incompetence, informed consent should be obtained from the legal
\nguardian in accordance with national legislation. Where physical or mental
\n3 17.C
\nincapacity makes it impossible to obtain informed consent, or when the subject is
\na minor, permission from the responsible relative replaces that of the subject in
\naccordance with national legislation.
\nWhenever the minor child is in fact able to give a consent, the minor’s consent
\nmust be obtained in addition to the consent of the minor’s legal guardian.
\n12. The research protocol should always contain a statement of the ethical
\nconsiderations involved and should indicate that the principles enunciated in the
\npresent Declaration are complied 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
\ndiagnostic and therapeutic measure, if in his or her judgment it offers hope of
\nsaving life, reestablishing health or alleviating suffering.
\n2. The potential benefits, hazards and discomfort of a new method should be
\nweighed against the advantages of the best current diagnostic and therapeutic
\nmethods.
\n3. In any medical study, every patient – including those of a control group, if any –
\nshould be assured of the best proven diagnostic and therapeutic method. This does
\nnot exclude the use of inert placebo in studies where no proven diagnostic or
\ntherapeutic method exists.
\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
\nreasons for this proposal should be stated in the experimental protocol for
\ntransmission to the independent committee (I, 2).
\n6. The physician can combine medical research with professional care, the objective
\nbeing the acquisition of new medical knowledge, only to the extent that medical
\nresearch is justified 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
\nbeing, it is the duty of the physician to remain the protector of the life and health of
\nthat person on whom biomedical research is being carried out.
\n2. The subjects should be volunteers – either healthy persons or patients for whom
\nthe experimental design is not related to the patient’s illness.
\n3. The investigator or the investigating team should discontinue the research if in
\nhis\/her or their judgment it may, if continued, be harmful to the individual.
\n4. In research on man, the interest of science and society should never take
\nprecedence over considerations related to the wellbeing of the subject.
\n\uf0a7 \uf0a7 \uf0a7<\/p>\n"},"caption":{"rendered":"

October 1996 17.C Original: English WORLD MEDICAL ASSOCIATION 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 41st World Medical Assembly, […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{"sizes":{"thumbnail":{"file":"DoH-Oct1996-pdf-106x150.jpg","width":106,"height":150,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1996-pdf-106x150.jpg"},"medium":{"file":"DoH-Oct1996-pdf-212x300.jpg","width":212,"height":300,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1996-pdf-212x300.jpg"},"large":{"file":"DoH-Oct1996-pdf-724x1024.jpg","width":724,"height":1024,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1996-pdf-724x1024.jpg"},"full":{"file":"DoH-Oct1996-pdf.jpg","width":1058,"height":1497,"mime_type":"application\/pdf","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1996-pdf.jpg"}}},"post":857,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct1996.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/9643"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=9643"}]}}