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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, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
53rd WMA General Assembly, Washington, DC, USA, October 2002 (Note of Clarification added)
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)
59th WMA General Assembly, Seoul, Republic of Korea, October 2008
64th WMA General Assembly, Fortaleza, Brazil, October 2013
Preamble
1. The World Medical Association (WMA) has developed the Dec-
larationofHelsinkiasastatementofethicalprinciplesformedi-
cal research involving human subjects, including research on
identifiable human material and data.
The Declaration is intended to be read as a whole and each of
its constituent paragraphs should be applied with consider-
ation of all other relevant paragraphs.
2. ConsistentwiththemandateoftheWMA,theDeclarationisad-
dressed primarily to physicians. The WMA encourages others
who are involved in medical research involving human subjects
to adopt these principles.
General Principles
3. TheDeclarationofGenevaoftheWMAbindsthephysicianwith
the words, “The health of my patient will be my first consider-
ation,”andtheInternationalCodeofMedicalEthicsdeclaresthat,
“A physician shall act in the patient’s best interest when provid-
ing medical care.”
4. It is the duty of the physician to promote and safeguard the
health,well-beingandrightsofpatients,includingthosewhoare
involvedinmedicalresearch.Thephysician’sknowledgeandcon-
science are dedicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must in-
clude studies involving human subjects.
6. Theprimarypurposeofmedicalresearchinvolvinghumansub-
jects is to understand the causes, development and effects of
diseasesandimprovepreventive,diagnosticandtherapeuticin-
terventions (methods, procedures and treatments). Even the
bestproveninterventionsmustbeevaluatedcontinuallythrough
research for their safety, effectiveness, efficiency, accessibility
and quality.
7. Medicalresearchissubjecttoethicalstandardsthatpromoteand
ensure respect for all human subjects and protect their health
and rights.
8. Whiletheprimarypurposeofmedicalresearchistogeneratenew
knowledge, this goal can never take precedence over the rights
and interests of individual research subjects.
9. Itisthedutyofphysicianswhoareinvolvedinmedicalresearch
to protect the life, health, dignity, integrity, right to self-
determination,privacy,andconfidentialityofpersonalinforma-
tion of research subjects. The responsibility for the protection
ofresearchsubjectsmustalwaysrestwiththephysicianorother
health care professionals and never with the research subjects,
even though they have given consent.
10. Physiciansmustconsidertheethical,legalandregulatorynorms
andstandardsforresearchinvolvinghumansubjectsintheirown
countries as well as applicable international norms and stan-
dards.Nonationalorinternationalethical,legalorregulatoryre-
quirementshouldreduceoreliminateanyoftheprotectionsfor
research subjects set forth in this Declaration.
11. Medical research should be conducted in a manner that mini-
mises possible harm to the environment.
12. Medicalresearchinvolvinghumansubjectsmustbeconducted
onlybyindividualswiththeappropriateethicsandscientificedu-
cation, training and qualifications. Research on patients or
healthyvolunteersrequiresthesupervisionofacompetentand
appropriately qualified physician or other health care profes-
sional.
Clinical Review & Education
Special Communication
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13. Groups that are underrepresented in medical research should
be provided appropriate access to participation in research.
14. Physicians who combine medical research with medical care
should involve their patients in research only to the extent that
this is justified by its potential preventive, diagnostic or thera-
peuticvalueandifthephysicianhasgoodreasontobelievethat
participation in the research study will not adversely affect the
health of the patients who serve as research subjects.
15. Appropriate compensation and treatment for subjects who are
harmed as a result of participating in research must be en-
sured.
Risks, Burdens and Benefits
16. Inmedicalpracticeandinmedicalresearch,mostinterventions
involve risks and burdens.
Medical research involving human subjects may only be con-
ductediftheimportanceoftheobjectiveoutweighstherisksand
burdens to the research subjects.
17. All medical research involving human subjects must be pre-
ceded by careful assessment of predictable risks and burdens
to the individuals and groups involved in the research in com-
parisonwithforeseeablebenefitstothemandtootherindividu-
als or groups affected by the condition under investigation.
Measurestominimisetherisksmustbeimplemented.Therisks
mustbecontinuouslymonitored,assessedanddocumentedby
the researcher.
18. Physiciansmaynotbeinvolvedinaresearchstudyinvolvinghu-
mansubjectsunlesstheyareconfidentthattheriskshavebeen
adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or
when there is conclusive proof of definitive outcomes, physi-
cians must assess whether to continue, modify or immediately
stop the study.
Vulnerable Groups and Individuals
19. Somegroupsandindividualsareparticularlyvulnerableandmay
haveanincreasedlikelihoodofbeingwrongedorofincurringad-
ditional harm.
All vulnerable groups and individuals should receive specifi-
cally considered protection.
20. Medical research with a vulnerable group is only justified if the
research is responsive to the health needs or priorities of this
group and the research cannot be carried out in a non-
vulnerable group. In addition, this group should stand to ben-
efit from the knowledge, practices or interventions that result
from the research.
Scientific Requirements and Research Protocols
21. Medicalresearchinvolvinghumansubjectsmustconformtogen-
erally accepted scientific principles, be based on a thorough
knowledge of the scientific literature, other relevant sources of
information, and adequate laboratory and, as appropriate, ani-
mal experimentation. The welfare of animals used for research
must be respected.
22. The design and performance of each research study involving
human subjects must be clearly described and justified in a re-
search protocol.
The protocol should contain a statement of the ethical consid-
erations involved and should indicate how the principles in this
Declaration have been addressed. The protocol should include
information regarding funding, sponsors, institutional affilia-
tions, potential conflicts of interest, incentives for subjects and
information regarding provisions for treating and/or compen-
sating subjects who are harmed as a consequence of participa-
tion in the research study.
In clinical trials, the protocol must also describe appropriate ar-
rangements for post-trial provisions.
Research Ethics Committees
23. Theresearchprotocolmustbesubmittedforconsideration,com-
ment, guidance and approval to the concerned research ethics
committee before the study begins. This committee must be
transparent in its functioning, must be independent of the re-
searcher, the sponsor and any other undue influence and must
be duly qualified. It must take into consideration the laws and
regulations of the country or countries in which the research is
to be performed as well as applicable international norms and
standardsbutthesemustnotbeallowedtoreduceoreliminate
anyoftheprotectionsforresearchsubjectssetforthinthisDec-
laration.
The committee must have the right to monitor ongoing stud-
ies.Theresearchermustprovidemonitoringinformationtothe
committee, especially information about any serious adverse
events. No amendment to the protocol may be made without
consideration and approval by the committee. After the end of
thestudy,theresearchersmustsubmitafinalreporttothecom-
mittee containing a summary of the study’s findings and con-
clusions.
Privacy and Confidentiality
24. Every precaution must be taken to protect the privacy of re-
search subjects and the confidentiality of their personal infor-
mation.
Informed Consent
25. Participation by individuals capable of giving informed consent
as subjects in medical research must be voluntary. Although it
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may be appropriate to consult family members or community
leaders, no individual capable of giving informed consent may
be enrolled in a research study unless he or she freely agrees.
26. In medical research involving human subjects capable of giving
informed consent, each potential subject must be adequately
informed of the aims, methods, sources of funding, any pos-
sible conflicts of interest, institutional affiliations of the re-
searcher,theanticipatedbenefitsandpotentialrisksofthestudy
and the discomfort it may entail, post-study provisions and any
other relevant aspects of the study. The potential subject must
be informed of the right to refuse to participate in the study or
to withdraw consent to participate at any time without repri-
sal. Special attention should be given to the specific informa-
tionneedsofindividualpotentialsubjectsaswellastothemeth-
ods used to deliver the information.
Afterensuringthatthepotentialsubjecthasunderstoodthein-
formation, the physician or another appropriately qualified in-
dividual must then seek the potential subject’s freely-given in-
formed consent, preferably in writing. If the consent cannot be
expressedinwriting,thenon-writtenconsentmustbeformally
documented and witnessed.
Allmedicalresearchsubjectsshouldbegiventheoptionofbeing
informed about the general outcome and results of the study.
27. When seeking informed consent for participation in a research
study the physician must be particularly cautious if the poten-
tial subject is in a dependent relationship with the physician or
mayconsentunderduress.Insuchsituationstheinformedcon-
sentmustbesoughtbyanappropriatelyqualifiedindividualwho
is completely independent of this relationship.
28. For a potential research subject who is incapable of giving in-
formedconsent,thephysicianmustseekinformedconsentfrom
thelegallyauthorisedrepresentative.Theseindividualsmustnot
be included in a research study that has no likelihood of benefit
forthemunlessitisintendedtopromotethehealthofthegroup
represented by the potential subject, the research cannot in-
stead be performed with persons capable of providing in-
formed consent, and the research entails only minimal risk and
minimal burden.
29. When a potential research subject who is deemed incapable of
givinginformedconsentisabletogiveassenttodecisionsabout
participationinresearch,thephysicianmustseekthatassentin
addition to the consent of the legally authorised representa-
tive. The potential subject’s dissent should be respected.
30. Research involving subjects who are physically or mentally in-
capable of giving consent, for example, unconscious patients,
may be done only if the physical or mental condition that pre-
ventsgivinginformedconsentisanecessarycharacteristicofthe
research group. In such circumstances the physician must seek
informedconsentfromthelegallyauthorisedrepresentative.If
nosuchrepresentativeisavailableandiftheresearchcannotbe
delayed,thestudymayproceedwithoutinformedconsentpro-
videdthatthespecificreasonsforinvolvingsubjectswithacon-
dition that renders them unable to give informed consent have
beenstatedintheresearchprotocolandthestudyhasbeenap-
provedbyaresearchethicscommittee.Consenttoremaininthe
researchmustbeobtainedassoonaspossiblefromthesubject
or a legally authorised representative.
31. Thephysicianmustfullyinformthepatientwhichaspectsoftheir
care are related to the research. The refusal of a patient to par-
ticipateinastudyorthepatient’sdecisiontowithdrawfromthe
study must never adversely affect the patient-physician rela-
tionship.
32. For medical research using identifiable human material or data,
such as research on material or data contained in biobanks or
similarrepositories,physiciansmustseekinformedconsentfor
its collection, storage and/or reuse. There may be exceptional
situations where consent would be impossible or impracti-
cable to obtain for such research. In such situations the re-
search may be done only after consideration and approval of a
research ethics committee.
Use of Placebo
33. The benefits, risks, burdens and effectiveness of a new inter-
vention must be tested against those of the best proven inter-
vention(s), except in the following circumstances:
Where no proven intervention exists, the use of placebo, or no
intervention, is acceptable; or
Where for compelling and scientifically sound methodological
reasons the use of any intervention less effective than the best
proven one, the use of placebo, or no intervention is necessary
to determine the efficacy or safety of an intervention
andthepatientswhoreceiveanyinterventionlesseffectivethan
thebestprovenone,placebo,ornointerventionwillnotbesub-
ject to additional risks of serious or irreversible harm as a result
of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option.
Post-Trial Provisions
34. Inadvanceofaclinicaltrial,sponsors,researchersandhostcoun-
trygovernmentsshouldmakeprovisionsforpost-trialaccessfor
all participants who still need an intervention identified as ben-
eficialinthetrial.Thisinformationmustalsobedisclosedtopar-
ticipants during the informed consent process.
Research Registration and Publication and Dissemination
of Results
35. Every research study involving human subjects must be regis-
teredinapubliclyaccessibledatabasebeforerecruitmentofthe
first subject.
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36. Researchers, authors, sponsors, editors and publishers all have
ethical obligations with regard to the publication and dissemi-
nationoftheresultsofresearch.Researchershaveadutytomake
publicly available the results of their research on human sub-
jectsandareaccountableforthecompletenessandaccuracyof
their reports. All parties should adhere to accepted guidelines
for ethical reporting. Negative and inconclusive as well as posi-
tiveresultsmustbepublishedorotherwisemadepubliclyavail-
able. Sources of funding, institutional affiliations and conflicts
of interest must be declared in the publication. Reports of re-
search not in accordance with the principles of this Declaration
should not be accepted for publication.
Unproven Interventions in Clinical Practice
37. In the treatment of an individual patient, where proven inter-
ventions do not exist or other known interventions have been
ineffective, the physician, after seeking expert advice, with in-
formed consent from the patient or a legally authorised repre-
sentative, may use an unproven intervention if in the physi-
cian’s judgement it offers hope of saving life, re-establishing
health or alleviating suffering. This intervention should subse-
quently be made the object of research, designed to evaluate
its safety and efficacy. In all cases, new information must be re-
corded and, where appropriate, made publicly available.
ARTICLE INFORMATION
Corresponding Author: World Medical
Association, 13, ch. du Levant, CIB – Bâtiment A,
01210 Ferney-Voltaire, France; wma@wma.net.
Published Online: October 19, 2013.
doi:10.1001/jama.2013.281053.
Disclaimer: ©2013 World Medical Association, Inc.
All Rights Reserved. All intellectual property rights
in the Declaration of Helsinki are vested in the
World Medical Association. The WMA has granted
JAMA exclusive rights to publish the
English-language version of the Declaration
through December 31, 2013.
Online-Only Content: Audio podcast is available at
www.jama.com.
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