{"id":9652,"date":"2017-11-23T16:17:14","date_gmt":"2017-11-23T16:17:14","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2008.pdf"},"modified":"2017-11-23T16:17:14","modified_gmt":"2017-11-23T16:17:14","slug":"doh-oct2008-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/que-hacemos\/etica-medica\/declaracion-de-helsinki\/doh-oct2008-2\/","title":{"rendered":"DoH-Oct2008"},"author":5,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

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

1
\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, and 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
\n52nd WMA General Assembly, Edinburgh, Scotland, October 2000
\n53th WMA General Assembly, Washington, United States, October 2002
\n(Note of Clarification on paragraph 29 added)
\n55th WMA General Assembly, Tokyo, Japan, October 2004
\n(Note of Clarification on Paragraph 30 added)
\nWMA General Assembly, Seoul, Korea, October 2008
\nA. INTRODUCTION
\n1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a
\nstatement of ethical principles for medical research involving human subjects, including
\nresearch on identifiable human material and data.
\nThe Declaration is intended to be read as a whole and each of its constituent paragraphs
\nshould not be applied without consideration of all other relevant paragraphs.
\n2. Although the Declaration is addressed primarily to physicians, the WMA encourages
\nother participants in medical research involving human subjects to adopt these
\nprinciples.
\n3. It is the duty of the physician to promote and safeguard the health of patients, including
\nthose who are involved in medical research. The physician’s knowledge and conscience
\nare dedicated to the fulfilment of this duty.
\n4. The Declaration of Geneva of the WMA binds the physician with the words, \u201cThe
\nhealth of my patient will be my first consideration,\u201d and the International Code of
\nMedical Ethics declares that, \u201cA physician shall act in the patient’s best interest when
\nproviding medical care.\u201d
\n5. Medical progress is based on research that ultimately must include studies involving
\nhuman subjects. Populations that are underrepresented in medical research should be
\nprovided appropriate access to participation in research.
\n6. In medical research involving human subjects, the well-being of the individual research
\nsubject must take precedence over all other interests.
\n7. The primary purpose of medical research involving human subjects is to understand the
\ncauses, development and effects of diseases and improve preventive, diagnostic and
\ntherapeutic interventions (methods, procedures and treatments). Even the best current
\nDoH\/Oct2008
\n2
\ninterventions must be evaluated continually through research for their safety,
\neffectiveness, efficiency, accessibility and quality.
\n8. In medical practice and in medical research, most interventions involve risks and
\nburdens.
\n9. Medical research is subject to ethical standards that promote respect for all human
\nsubjects and protect their health and rights. Some research populations are particularly
\nvulnerable and need special protection. These include those who cannot give or refuse
\nconsent for themselves and those who may be vulnerable to coercion or undue
\ninfluence.
\n10. Physicians should consider the ethical, legal and regulatory norms and standards for
\nresearch involving human subjects in their own countries as well as applicable
\ninternational norms and standards. No national or international ethical, legal or
\nregulatory requirement should reduce or eliminate any of the protections for research
\nsubjects set forth in this Declaration.
\nB. PRINCIPLES FOR ALL MEDICAL RESEARCH
\n11. It is the duty of physicians who participate in medical research to protect the life, health,
\ndignity, integrity, right to self-determination, privacy, and confidentiality of personal
\ninformation of research subjects.
\n12. Medical research involving human subjects must conform to generally accepted
\nscientific principles, be based on a thorough knowledge of the scientific literature, other
\nrelevant sources of information, and adequate laboratory and, as appropriate, animal
\nexperimentation. The welfare of animals used for research must be respected.
\n13. Appropriate caution must be exercised in the conduct of medical research that may
\nharm the environment.
\n14. The design and performance of each research study involving human subjects must be
\nclearly described in a research protocol. The protocol should contain a statement of the
\nethical considerations involved and should indicate how the principles in this
\nDeclaration have been addressed. The protocol should include information regarding
\nfunding, sponsors, institutional affiliations, other potential conflicts of interest,
\nincentives for subjects and provisions for treating and\/or compensating subjects who are
\nharmed as a consequence of participation in the research study. The protocol should
\ndescribe arrangements for post-study access by study subjects to interventions identified
\nas beneficial in the study or access to other appropriate care or benefits.
\n15. The research protocol must be submitted for consideration, comment, guidance and
\napproval to a research ethics committee before the study begins. This committee must
\nbe independent of the researcher, the sponsor and any other undue influence. It must
\ntake into consideration the laws and regulations of the country or countries in which the
\nresearch is to be performed as well as applicable international norms and standards but
\nthese must not be allowed to reduce or eliminate any of the protections for research
\nsubjects set forth in this Declaration. The committee must have the right to monitor
\nDoH\/Oct2008
\n3
\nongoing studies. The researcher must provide monitoring information to the committee,
\nespecially information about any serious adverse events. No change to the protocol may
\nbe made without consideration and approval by the committee.
\n16. Medical research involving human subjects must be conducted only by individuals with
\nthe appropriate scientific training and qualifications. Research on patients or healthy
\nvolunteers requires the supervision of a competent and appropriately qualified physician
\nor other health care professional. The responsibility for the protection of research
\nsubjects must always rest with the physician or other health care professional and never
\nthe research subjects, even though they have given consent.
\n17. Medical research involving a disadvantaged or vulnerable population or community is
\nonly justified if the research is responsive to the health needs and priorities of this
\npopulation or community and if there is a reasonable likelihood that this population or
\ncommunity stands to benefit from the results of the research.
\n18. Every medical research study involving human subjects must be preceded by careful
\nassessment of predictable risks and burdens to the individuals and communities
\ninvolved in the research in comparison with foreseeable benefits to them and to other
\nindividuals or communities affected by the condition under investigation.
\n19. Every clinical trial must be registered in a publicly accessible database before
\nrecruitment of the first subject.
\n20. Physicians may not participate in a research study involving human subjects unless they
\nare confident that the risks involved have been adequately assessed and can be
\nsatisfactorily managed. Physicians must immediately stop a study when the risks are
\nfound to outweigh the potential benefits or when there is conclusive proof of positive
\nand beneficial results.
\n21. Medical research involving human subjects may only be conducted if the importance of
\nthe objective outweighs the inherent risks and burdens to the research subjects.
\n22. Participation by competent individuals as subjects in medical research must be
\nvoluntary. Although it may be appropriate to consult family members or community
\nleaders, no competent individual may be enrolled in a research study unless he or she
\nfreely agrees.
\n23. Every precaution must be taken to protect the privacy of research subjects and the
\nconfidentiality of their personal information and to minimize the impact of the study on
\ntheir physical, mental and social integrity.
\n24. In medical research involving competent human subjects, each potential subject must be
\nadequately informed of the aims, methods, sources of funding, any possible conflicts of
\ninterest, institutional affiliations of the researcher, the anticipated benefits and potential
\nrisks of the study and the discomfort it may entail, and any other relevant aspects of the
\nstudy. The potential subject must be informed of the right to refuse to participate in the
\nstudy or to withdraw consent to participate at any time without reprisal. Special
\nattention should be given to the specific information needs of individual potential
\nsubjects as well as to the methods used to deliver the information. After ensuring that
\nDoH\/Oct2008
\n4
\nthe potential subject has understood the information, the physician or another
\nappropriately qualified individual must then seek the potential subject\u2019s freely-given
\ninformed consent, preferably in writing. If the consent cannot be expressed in writing,
\nthe non-written consent must be formally documented and witnessed.
\n25. For medical research using identifiable human material or data, physicians must
\nnormally seek consent for the collection, analysis, storage and\/or reuse. There may be
\nsituations where consent would be impossible or impractical to obtain for such research
\nor would pose a threat to the validity of the research. In such situations the research may
\nbe done only after consideration and approval of a research ethics committee.
\n26. When seeking informed consent for participation in a research study the physician
\nshould be particularly cautious if the potential subject is in a dependent relationship
\nwith the physician or may consent under duress. In such situations the informed consent
\nshould be sought by an appropriately qualified individual who is completely
\nindependent of this relationship.
\n27. For a potential research subject who is incompetent, the physician must seek informed
\nconsent from the legally authorized representative. These individuals must not be
\nincluded in a research study that has no likelihood of benefit for them unless it is
\nintended to promote the health of the population represented by the potential subject,
\nthe research cannot instead be performed with competent persons, and the research
\nentails only minimal risk and minimal burden.
\n28. When a potential research subject who is deemed incompetent is able to give assent to
\ndecisions about participation in research, the physician must seek that assent in addition
\nto the consent of the legally authorized representative. The potential subject\u2019s dissent
\nshould be respected.
\n29. Research involving subjects who are physically or mentally incapable of giving
\nconsent, for example, unconscious patients, may be done only if the physical or mental
\ncondition that prevents giving informed consent is a necessary characteristic of the
\nresearch population. In such circumstances the physician should seek informed consent
\nfrom the legally authorized representative. If no such representative is available and if
\nthe research cannot be delayed, the study may proceed without informed consent
\nprovided that the specific reasons for involving subjects with a condition that renders
\nthem unable to give informed consent have been stated in the research protocol and the
\nstudy has been approved by a research ethics committee. Consent to remain in the
\nresearch should be obtained as soon as possible from the subject or a legally authorized
\nrepresentative.
\n30. Authors, editors and publishers all have ethical obligations with regard to the
\npublication of the results of research. Authors have a duty to make publicly available
\nthe results of their research on human subjects and are accountable for the completeness
\nand accuracy of their reports. They should adhere to accepted guidelines for ethical
\nreporting. Negative and inconclusive as well as positive results should be published or
\notherwise made publicly available. Sources of funding, institutional affiliations and
\nconflicts of interest should be declared in the publication. Reports of research not in
\naccordance with the principles of this Declaration should not be accepted for
\npublication.
\nDoH\/Oct2008
\n5
\nC. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH
\nMEDICAL CARE
\n31. The physician may combine medical research with medical care only to the extent that
\nthe research is justified by its potential preventive, diagnostic or therapeutic value and if
\nthe physician has good reason to believe that participation in the research study will not
\nadversely affect the health of the patients who serve as research subjects.
\n32. The benefits, risks, burdens and effectiveness of a new intervention must be tested
\nagainst those of the best current proven intervention, except in the following
\ncircumstances:
\n\u2022 The use of placebo, or no treatment, is acceptable in studies where no current
\nproven intervention exists; or
\n\u2022 Where for compelling and scientifically sound methodological reasons the use of
\nplacebo is necessary to determine the efficacy or safety of an intervention and the
\npatients who receive placebo or no treatment will not be subject to any risk of
\nserious or irreversible harm. Extreme care must be taken to avoid abuse of this
\noption.
\n33. At the conclusion of the study, patients entered into the study are entitled to be
\ninformed about the outcome of the study and to share any benefits that result from it, for
\nexample, access to interventions identified as beneficial in the study or to other
\nappropriate care or benefits.
\n34. The physician must fully inform the patient which aspects of the care are related to the
\nresearch. The refusal of a patient to participate in a study or the patient\u2019s decision to
\nwithdraw from the study must never interfere with the patient-physician relationship.
\n35. In the treatment of a patient, where proven interventions do not exist or have been
\nineffective, the physician, after seeking expert advice, with informed consent from the
\npatient or a legally authorized representative, may use an unproven intervention if in the
\nphysician’s judgement it offers hope of saving life, re-establishing health or alleviating
\nsuffering. Where possible, this intervention should be made the object of research,
\ndesigned to evaluate its safety and efficacy. In all cases, new information should be
\nrecorded and, where appropriate, made publicly available.
\n\u2605\u2605\u2605<\/p>\n"},"caption":{"rendered":"

1 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 General Assembly, Hong Kong, September […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{"sizes":{"thumbnail":{"file":"DoH-Oct2008-pdf-106x150.jpg","width":106,"height":150,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2008-pdf-106x150.jpg"},"medium":{"file":"DoH-Oct2008-pdf-212x300.jpg","width":212,"height":300,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2008-pdf-212x300.jpg"},"large":{"file":"DoH-Oct2008-pdf-724x1024.jpg","width":724,"height":1024,"mime_type":"image\/jpeg","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2008-pdf-724x1024.jpg"},"full":{"file":"DoH-Oct2008-pdf.jpg","width":1058,"height":1497,"mime_type":"application\/pdf","source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2008-pdf.jpg"}}},"post":857,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2008.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/9652"}],"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=9652"}]}}