{"id":9646,"date":"2017-11-23T16:17:10","date_gmt":"2017-11-23T16:17:10","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2000.pdf"},"modified":"2017-11-23T16:17:10","modified_gmt":"2017-11-23T16:17:10","slug":"doh-oct2000-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/que-hacemos\/etica-medica\/declaracion-de-helsinki\/doh-oct2000-2\/","title":{"rendered":"DoH-Oct2000"},"author":5,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

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

Initiated: 1964 17.C
\nOriginal: English
\nWORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
\nEthical Principles
\nfor
\nMedical Research Involving Human Subjects
\nAdopted by the 18th WMA General Assembly
\nHelsinki, 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
\n52nd
\nWMA General Assembly, Edinburgh, Scotland, October 2000
\nA. INTRODUCTION
\n1. The World Medical Association has developed the Declaration of Helsinki as a statement
\nof ethical 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\u2019s 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
\nthe words, \u00abThe health of my patient will be my first consideration,\u00bb and the International
\nCode of Medical Ethics declares that, \u00abA physician shall act only in the patient’s interest
\nwhen providing medical care which might have the effect of weakening the physical and
\nmental condition of the patient.\u00bb
\n4. Medical progress is based on research which ultimately must rest in part on
\nexperimentation involving 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
\naetiology and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and
\n17.C
\n2
\ntherapeutic methods must continuously be challenged through research for their
\neffectiveness, efficiency, accessibility and quality.
\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
\nresearch is combined with care.
\n9. Research Investigators should be aware of the ethical, legal and regulatory requirements
\nfor research 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
\n10. It is the duty of the physician in medical research to protect the life, health, privacy, and
\ndignity of the human subject.
\n11. 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.
\n12. 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.
\n13. The design and performance of each experimental procedure involving human subjects
\nshould be clearly formulated in an experimental protocol. This protocol should be
\nsubmitted for consideration, comment, guidance, and where appropriate, approval to a
\nspecially appointed ethical review committee, which must be independent of the
\ninvestigator, the sponsor or any other kind of undue influence. This independent
\ncommittee should be in conformity with the laws and regulations of the country in which
\nthe research experiment is performed. The committee has the right to monitor ongoing
\ntrials. The researcher has the obligation to provide monitoring information to the
\ncommittee, especially any serious adverse events. The researcher should also submit to
\nthe committee, for review, information regarding funding, sponsors, institutional
\naffiliations, other potential conflicts of interest and incentives for subjects.
\n14. 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
\nthis Declaration.
\n17.C
\n3
\n15. 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
\nand never rest on the subject of the research, even though the subject has given consent.
\n16. Every medical research project involving human subjects should be preceded by careful
\nassessment of predictable risks and burdens in comparison with foreseeable benefits to
\nthe subject or to others. This does not preclude the participation of healthy volunteers in
\nmedical research. The design of all studies should be publicly available.
\n17. 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.
\n18. 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.
\n19. 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.
\n20. The subjects must be volunteers and informed participants in the research project.
\n21. 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\u2019s information and to minimize the impact of the study on the subject’s physical
\nand mental integrity and on the personality of the subject.
\n22. In any research on human beings, each potential subject must be adequately informed of
\nthe aims, methods, sources of funding, any possible conflicts of interest, institutional
\naffiliations of the researcher, the anticipated benefits and potential risks of the study and
\nthe discomfort it may entail. The subject should be informed of the right to abstain from
\nparticipation in the study or to withdraw consent to participate at any time without reprisal.
\nAfter ensuring that the subject has understood the information, the physician should then
\nobtain the subject’s freely-given informed consent, preferably in writing. If the consent
\ncannot be obtained in writing, the non-written consent must be formally documented and
\nwitnessed.
\n23. 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.
\n24. For a research subject who is legally incompetent, physically or mentally incapable of
\ngiving consent or is a legally incompetent minor, the investigator must obtain informed
\nconsent from the legally authorized representative in accordance with applicable law.
\nThese groups should not be included in research unless the research is necessary to
\n17.C
\n4
\npromote the health of the population represented and this research cannot instead be
\nperformed on legally competent persons.
\n25. When a subject deemed legally incompetent, such as a minor child, is able to give assent
\nto decisions about participation in research, the investigator must obtain that assent in
\naddition to the consent of the legally authorized representative.
\n26. Research on individuals from whom it is not possible to obtain consent, including proxy
\nor advance 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
\nto give informed consent should be stated in the experimental protocol for consideration
\nand approval of the review committee. The protocol should state that consent to remain in
\nthe research should be obtained as soon as possible from the individual or a legally
\nauthorized surrogate.
\n27. Both authors and publishers have ethical obligations. In publication of the results of
\nresearch, the investigators are obliged to preserve the accuracy of the results. Negative as
\nwell as positive results should be published or otherwise publicly available. Sources of
\nfunding, institutional affiliations and any possible conflicts of interest should be declared
\nin the publication. Reports of experimentation not in accordance with the principles laid
\ndown in this Declaration should not be accepted for publication.
\nC. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH
\nMEDICAL CARE
\n28. The physician may combine medical research with medical care, only to the extent that
\nthe research is justified by its potential prophylactic, diagnostic or therapeutic value.
\nWhen medical research is combined with medical care, additional standards apply to
\nprotect the patients who are research subjects.
\n29. The benefits, risks, burdens and effectiveness of a new method should be tested against
\nthose of the best current prophylactic, diagnostic, and therapeutic methods. This does not
\nexclude the use of placebo, or no treatment, in studies where no proven prophylactic,
\ndiagnostic or therapeutic method exists.
\n30. 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
\nthe study.
\n31. 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.
\n32. In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic
\nmethods do not exist or have been ineffective, the physician, with informed consent from
\nthe patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic
\nmeasures, if in the physician\u2019s judgement it offers hope of saving life, re-establishing
\n17.C
\n5
\nhealth or alleviating suffering. Where possible, these measures should be made the object
\nof research, designed to evaluate their safety and efficacy. In all cases, new information
\nshould be recorded and, where appropriate, published. The other relevant guidelines of
\nthis Declaration should be followed.
\n\uf0a7 \uf0a7 \uf0a7
\n7.10.2000 09h14<\/p>\n"},"caption":{"rendered":"

Initiated: 1964 17.C Original: English WORLD MEDICAL ASSOCIATION 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 General Assembly, Hong […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{"sizes":{"thumbnail":{"file":"DoH-Oct2000-pdf-106x150.jpg","width":106,"height":150,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2000-pdf-106x150.jpg"},"medium":{"file":"DoH-Oct2000-pdf-212x300.jpg","width":212,"height":300,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2000-pdf-212x300.jpg"},"large":{"file":"DoH-Oct2000-pdf-724x1024.jpg","width":724,"height":1024,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2000-pdf-724x1024.jpg"},"full":{"file":"DoH-Oct2000-pdf.jpg","width":1058,"height":1497,"mime_type":"application\/pdf","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2000-pdf.jpg"}}},"post":857,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2000.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/9646"}],"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=9646"}]}}