{"id":6104,"date":"2017-02-08T18:02:31","date_gmt":"2017-02-08T18:02:31","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2013-JAMA.pdf"},"modified":"2017-02-08T18:06:52","modified_gmt":"2017-02-08T18:06:52","slug":"doh-oct2013-jama","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/que-hacemos\/etica-medica\/declaracion-de-helsinki\/doh-oct2013-jama\/","title":{"rendered":"DoH-Oct2013-JAMA"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

DoH-Oct2013-JAMA<\/a><\/p>\n

Copyright 2013 American Medical Association. All rights reserved.
\nWorld Medical Association Declaration of Helsinki
\nEthical Principles for Medical Research
\nInvolving Human Subjects
\nWorld Medical Association
\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
\n53rd WMA General Assembly, Washington, DC, USA, October 2002 (Note of Clarification added)
\n55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)
\n59th WMA General Assembly, Seoul, Republic of Korea, October 2008
\n64th WMA General Assembly, Fortaleza, Brazil, October 2013
\nPreamble
\n1. The World Medical Association (WMA) has developed the Dec-
\nlarationofHelsinkiasastatementofethicalprinciplesformedi-
\ncal research involving human subjects, including research on
\nidentifiable human material and data.
\nThe Declaration is intended to be read as a whole and each of
\nits constituent paragraphs should be applied with consider-
\nation of all other relevant paragraphs.
\n2. ConsistentwiththemandateoftheWMA,theDeclarationisad-
\ndressed primarily to physicians. The WMA encourages others
\nwho are involved in medical research involving human subjects
\nto adopt these principles.
\nGeneral Principles
\n3. TheDeclarationofGenevaoftheWMAbindsthephysicianwith
\nthe words, \u201cThe health of my patient will be my first consider-
\nation,\u201dandtheInternationalCodeofMedicalEthicsdeclaresthat,
\n\u201cA physician shall act in the patient’s best interest when provid-
\ning medical care.\u201d
\n4. It is the duty of the physician to promote and safeguard the
\nhealth,well-beingandrightsofpatients,includingthosewhoare
\ninvolvedinmedicalresearch.Thephysician’sknowledgeandcon-
\nscience are dedicated to the fulfilment of this duty.
\n5. Medical progress is based on research that ultimately must in-
\nclude studies involving human subjects.
\n6. Theprimarypurposeofmedicalresearchinvolvinghumansub-
\njects is to understand the causes, development and effects of
\ndiseasesandimprovepreventive,diagnosticandtherapeuticin-
\nterventions (methods, procedures and treatments). Even the
\nbestproveninterventionsmustbeevaluatedcontinuallythrough
\nresearch for their safety, effectiveness, efficiency, accessibility
\nand quality.
\n7. Medicalresearchissubjecttoethicalstandardsthatpromoteand
\nensure respect for all human subjects and protect their health
\nand rights.
\n8. Whiletheprimarypurposeofmedicalresearchistogeneratenew
\nknowledge, this goal can never take precedence over the rights
\nand interests of individual research subjects.
\n9. Itisthedutyofphysicianswhoareinvolvedinmedicalresearch
\nto protect the life, health, dignity, integrity, right to self-
\ndetermination,privacy,andconfidentialityofpersonalinforma-
\ntion of research subjects. The responsibility for the protection
\nofresearchsubjectsmustalwaysrestwiththephysicianorother
\nhealth care professionals and never with the research subjects,
\neven though they have given consent.
\n10. Physiciansmustconsidertheethical,legalandregulatorynorms
\nandstandardsforresearchinvolvinghumansubjectsintheirown
\ncountries as well as applicable international norms and stan-
\ndards.Nonationalorinternationalethical,legalorregulatoryre-
\nquirementshouldreduceoreliminateanyoftheprotectionsfor
\nresearch subjects set forth in this Declaration.
\n11. Medical research should be conducted in a manner that mini-
\nmises possible harm to the environment.
\n12. Medicalresearchinvolvinghumansubjectsmustbeconducted
\nonlybyindividualswiththeappropriateethicsandscientificedu-
\ncation, training and qualifications. Research on patients or
\nhealthyvolunteersrequiresthesupervisionofacompetentand
\nappropriately qualified physician or other health care profes-
\nsional.
\nClinical Review & Education
\nSpecial Communication
\njama.com JAMA November 27, 2013 Volume 310, Number 20 2191
\nCopyright 2013 American Medical Association. All rights reserved.
\nDownloaded From: http:\/\/jama.jamanetwork.com\/ by a American Medical Association User on 09\/23\/2015
\nCopyright 2013 American Medical Association. All rights reserved.
\n13. Groups that are underrepresented in medical research should
\nbe provided appropriate access to participation in research.
\n14. Physicians who combine medical research with medical care
\nshould involve their patients in research only to the extent that
\nthis is justified by its potential preventive, diagnostic or thera-
\npeuticvalueandifthephysicianhasgoodreasontobelievethat
\nparticipation in the research study will not adversely affect the
\nhealth of the patients who serve as research subjects.
\n15. Appropriate compensation and treatment for subjects who are
\nharmed as a result of participating in research must be en-
\nsured.
\nRisks, Burdens and Benefits
\n16. Inmedicalpracticeandinmedicalresearch,mostinterventions
\ninvolve risks and burdens.
\nMedical research involving human subjects may only be con-
\nductediftheimportanceoftheobjectiveoutweighstherisksand
\nburdens to the research subjects.
\n17. All medical research involving human subjects must be pre-
\nceded by careful assessment of predictable risks and burdens
\nto the individuals and groups involved in the research in com-
\nparisonwithforeseeablebenefitstothemandtootherindividu-
\nals or groups affected by the condition under investigation.
\nMeasurestominimisetherisksmustbeimplemented.Therisks
\nmustbecontinuouslymonitored,assessedanddocumentedby
\nthe researcher.
\n18. Physiciansmaynotbeinvolvedinaresearchstudyinvolvinghu-
\nmansubjectsunlesstheyareconfidentthattheriskshavebeen
\nadequately assessed and can be satisfactorily managed.
\nWhen the risks are found to outweigh the potential benefits or
\nwhen there is conclusive proof of definitive outcomes, physi-
\ncians must assess whether to continue, modify or immediately
\nstop the study.
\nVulnerable Groups and Individuals
\n19. Somegroupsandindividualsareparticularlyvulnerableandmay
\nhaveanincreasedlikelihoodofbeingwrongedorofincurringad-
\nditional harm.
\nAll vulnerable groups and individuals should receive specifi-
\ncally considered protection.
\n20. Medical research with a vulnerable group is only justified if the
\nresearch is responsive to the health needs or priorities of this
\ngroup and the research cannot be carried out in a non-
\nvulnerable group. In addition, this group should stand to ben-
\nefit from the knowledge, practices or interventions that result
\nfrom the research.
\nScientific Requirements and Research Protocols
\n21. Medicalresearchinvolvinghumansubjectsmustconformtogen-
\nerally accepted scientific principles, be based on a thorough
\nknowledge of the scientific literature, other relevant sources of
\ninformation, and adequate laboratory and, as appropriate, ani-
\nmal experimentation. The welfare of animals used for research
\nmust be respected.
\n22. The design and performance of each research study involving
\nhuman subjects must be clearly described and justified in a re-
\nsearch protocol.
\nThe protocol should contain a statement of the ethical consid-
\nerations involved and should indicate how the principles in this
\nDeclaration have been addressed. The protocol should include
\ninformation regarding funding, sponsors, institutional affilia-
\ntions, potential conflicts of interest, incentives for subjects and
\ninformation regarding provisions for treating and\/or compen-
\nsating subjects who are harmed as a consequence of participa-
\ntion in the research study.
\nIn clinical trials, the protocol must also describe appropriate ar-
\nrangements for post-trial provisions.
\nResearch Ethics Committees
\n23. Theresearchprotocolmustbesubmittedforconsideration,com-
\nment, guidance and approval to the concerned research ethics
\ncommittee before the study begins. This committee must be
\ntransparent in its functioning, must be independent of the re-
\nsearcher, the sponsor and any other undue influence and must
\nbe duly qualified. It must take into consideration the laws and
\nregulations of the country or countries in which the research is
\nto be performed as well as applicable international norms and
\nstandardsbutthesemustnotbeallowedtoreduceoreliminate
\nanyoftheprotectionsforresearchsubjectssetforthinthisDec-
\nlaration.
\nThe committee must have the right to monitor ongoing stud-
\nies.Theresearchermustprovidemonitoringinformationtothe
\ncommittee, especially information about any serious adverse
\nevents. No amendment to the protocol may be made without
\nconsideration and approval by the committee. After the end of
\nthestudy,theresearchersmustsubmitafinalreporttothecom-
\nmittee containing a summary of the study\u2019s findings and con-
\nclusions.
\nPrivacy and Confidentiality
\n24. Every precaution must be taken to protect the privacy of re-
\nsearch subjects and the confidentiality of their personal infor-
\nmation.
\nInformed Consent
\n25. Participation by individuals capable of giving informed consent
\nas subjects in medical research must be voluntary. Although it
\nClinical Review & Education Special Communication World Medical Association Declaration of Helsinki
\n2192 JAMA November 27, 2013 Volume 310, Number 20 jama.com
\nCopyright 2013 American Medical Association. All rights reserved.
\nDownloaded From: http:\/\/jama.jamanetwork.com\/ by a American Medical Association User on 09\/23\/2015
\nCopyright 2013 American Medical Association. All rights reserved.
\nmay be appropriate to consult family members or community
\nleaders, no individual capable of giving informed consent may
\nbe enrolled in a research study unless he or she freely agrees.
\n26. In medical research involving human subjects capable of giving
\ninformed consent, each potential subject must be adequately
\ninformed of the aims, methods, sources of funding, any pos-
\nsible conflicts of interest, institutional affiliations of the re-
\nsearcher,theanticipatedbenefitsandpotentialrisksofthestudy
\nand the discomfort it may entail, post-study provisions and any
\nother relevant aspects of the study. The potential subject must
\nbe informed of the right to refuse to participate in the study or
\nto withdraw consent to participate at any time without repri-
\nsal. Special attention should be given to the specific informa-
\ntionneedsofindividualpotentialsubjectsaswellastothemeth-
\nods used to deliver the information.
\nAfterensuringthatthepotentialsubjecthasunderstoodthein-
\nformation, the physician or another appropriately qualified in-
\ndividual must then seek the potential subject\u2019s freely-given in-
\nformed consent, preferably in writing. If the consent cannot be
\nexpressedinwriting,thenon-writtenconsentmustbeformally
\ndocumented and witnessed.
\nAllmedicalresearchsubjectsshouldbegiventheoptionofbeing
\ninformed about the general outcome and results of the study.
\n27. When seeking informed consent for participation in a research
\nstudy the physician must be particularly cautious if the poten-
\ntial subject is in a dependent relationship with the physician or
\nmayconsentunderduress.Insuchsituationstheinformedcon-
\nsentmustbesoughtbyanappropriatelyqualifiedindividualwho
\nis completely independent of this relationship.
\n28. For a potential research subject who is incapable of giving in-
\nformedconsent,thephysicianmustseekinformedconsentfrom
\nthelegallyauthorisedrepresentative.Theseindividualsmustnot
\nbe included in a research study that has no likelihood of benefit
\nforthemunlessitisintendedtopromotethehealthofthegroup
\nrepresented by the potential subject, the research cannot in-
\nstead be performed with persons capable of providing in-
\nformed consent, and the research entails only minimal risk and
\nminimal burden.
\n29. When a potential research subject who is deemed incapable of
\ngivinginformedconsentisabletogiveassenttodecisionsabout
\nparticipationinresearch,thephysicianmustseekthatassentin
\naddition to the consent of the legally authorised representa-
\ntive. The potential subject\u2019s dissent should be respected.
\n30. Research involving subjects who are physically or mentally in-
\ncapable of giving consent, for example, unconscious patients,
\nmay be done only if the physical or mental condition that pre-
\nventsgivinginformedconsentisanecessarycharacteristicofthe
\nresearch group. In such circumstances the physician must seek
\ninformedconsentfromthelegallyauthorisedrepresentative.If
\nnosuchrepresentativeisavailableandiftheresearchcannotbe
\ndelayed,thestudymayproceedwithoutinformedconsentpro-
\nvidedthatthespecificreasonsforinvolvingsubjectswithacon-
\ndition that renders them unable to give informed consent have
\nbeenstatedintheresearchprotocolandthestudyhasbeenap-
\nprovedbyaresearchethicscommittee.Consenttoremaininthe
\nresearchmustbeobtainedassoonaspossiblefromthesubject
\nor a legally authorised representative.
\n31. Thephysicianmustfullyinformthepatientwhichaspectsoftheir
\ncare are related to the research. The refusal of a patient to par-
\nticipateinastudyorthepatient\u2019sdecisiontowithdrawfromthe
\nstudy must never adversely affect the patient-physician rela-
\ntionship.
\n32. For medical research using identifiable human material or data,
\nsuch as research on material or data contained in biobanks or
\nsimilarrepositories,physiciansmustseekinformedconsentfor
\nits collection, storage and\/or reuse. There may be exceptional
\nsituations where consent would be impossible or impracti-
\ncable to obtain for such research. In such situations the re-
\nsearch may be done only after consideration and approval of a
\nresearch ethics committee.
\nUse of Placebo
\n33. The benefits, risks, burdens and effectiveness of a new inter-
\nvention must be tested against those of the best proven inter-
\nvention(s), except in the following circumstances:
\nWhere no proven intervention exists, the use of placebo, or no
\nintervention, is acceptable; or
\nWhere for compelling and scientifically sound methodological
\nreasons the use of any intervention less effective than the best
\nproven one, the use of placebo, or no intervention is necessary
\nto determine the efficacy or safety of an intervention
\nandthepatientswhoreceiveanyinterventionlesseffectivethan
\nthebestprovenone,placebo,ornointerventionwillnotbesub-
\nject to additional risks of serious or irreversible harm as a result
\nof not receiving the best proven intervention.
\nExtreme care must be taken to avoid abuse of this option.
\nPost-Trial Provisions
\n34. Inadvanceofaclinicaltrial,sponsors,researchersandhostcoun-
\ntrygovernmentsshouldmakeprovisionsforpost-trialaccessfor
\nall participants who still need an intervention identified as ben-
\neficialinthetrial.Thisinformationmustalsobedisclosedtopar-
\nticipants during the informed consent process.
\nResearch Registration and Publication and Dissemination
\nof Results
\n35. Every research study involving human subjects must be regis-
\nteredinapubliclyaccessibledatabasebeforerecruitmentofthe
\nfirst subject.
\nWorld Medical Association Declaration of Helsinki Special Communication Clinical Review & Education
\njama.com JAMA November 27, 2013 Volume 310, Number 20 2193
\nCopyright 2013 American Medical Association. All rights reserved.
\nDownloaded From: http:\/\/jama.jamanetwork.com\/ by a American Medical Association User on 09\/23\/2015
\nCopyright 2013 American Medical Association. All rights reserved.
\n36. Researchers, authors, sponsors, editors and publishers all have
\nethical obligations with regard to the publication and dissemi-
\nnationoftheresultsofresearch.Researchershaveadutytomake
\npublicly available the results of their research on human sub-
\njectsandareaccountableforthecompletenessandaccuracyof
\ntheir reports. All parties should adhere to accepted guidelines
\nfor ethical reporting. Negative and inconclusive as well as posi-
\ntiveresultsmustbepublishedorotherwisemadepubliclyavail-
\nable. Sources of funding, institutional affiliations and conflicts
\nof interest must be declared in the publication. Reports of re-
\nsearch not in accordance with the principles of this Declaration
\nshould not be accepted for publication.
\nUnproven Interventions in Clinical Practice
\n37. In the treatment of an individual patient, where proven inter-
\nventions do not exist or other known interventions have been
\nineffective, the physician, after seeking expert advice, with in-
\nformed consent from the patient or a legally authorised repre-
\nsentative, may use an unproven intervention if in the physi-
\ncian’s judgement it offers hope of saving life, re-establishing
\nhealth or alleviating suffering. This intervention should subse-
\nquently be made the object of research, designed to evaluate
\nits safety and efficacy. In all cases, new information must be re-
\ncorded and, where appropriate, made publicly available.
\nARTICLE INFORMATION
\nCorresponding Author: World Medical
\nAssociation, 13, ch. du Levant, CIB – B\u00e2timent A,
\n01210 Ferney-Voltaire, France; wma@wma.net.
\nPublished Online: October 19, 2013.
\ndoi:10.1001\/jama.2013.281053.
\nDisclaimer: \u00a92013 World Medical Association, Inc.
\nAll Rights Reserved. All intellectual property rights
\nin the Declaration of Helsinki are vested in the
\nWorld Medical Association. The WMA has granted
\nJAMA exclusive rights to publish the
\nEnglish-language version of the Declaration
\nthrough December 31, 2013.
\nOnline-Only Content: Audio podcast is available at
\nwww.jama.com.
\nClinical Review & Education Special Communication World Medical Association Declaration of Helsinki
\n2194 JAMA November 27, 2013 Volume 310, Number 20 jama.com
\nCopyright 2013 American Medical Association. All rights reserved.
\nDownloaded From: http:\/\/jama.jamanetwork.com\/ by a American Medical Association User on 09\/23\/2015<\/p>\n"},"caption":{"rendered":"

DoH-Oct2013-JAMA Copyright 2013 American Medical Association. All rights reserved. World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects World Medical Association 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, […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":857,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/DoH-Oct2013-JAMA.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/6104"}],"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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=6104"}]}}