WMA Declaration of Helsinki - EthicalPrinciples 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 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 ofClariﬁcation 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 Declaration of Helsinki

as a statement of ethical principles for medical 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 consideration of all other relevant paragraphs.
2.

Consistent with the mandate of the WMA, the Declaration is addressedprimarily to physicians. The WMA encourages others who are involved in medical
research involving human subjects to adopt these principles.

General Principles
3.

The Declaration of Geneva of the WMA binds the physician with the words,“The health of my patient will be my ﬁrst consideration,” and the International Code of 1/8

“The health of my patient will be my ﬁrst consideration,” and the International Code of
Medical Ethics declares that, “A physician shall act in the patient's best interest whenproviding medical care.”4.

It is the duty of the physician to promote and safeguard the health, well-being

and rights of patients, including those who are involved in medical research. The
physician's knowledge and conscience are dedicated to the fulﬁlment of this duty.
5.

Medical progress is based on research that ultimately must include studies

involving human subjects.
6.

The primary purpose of medical research involving human subjects is tounderstand the causes, development and eﬀects of diseases and improve preventive,diagnostic and therapeutic interventions (methods, procedures and treatments). Even
the best proven interventions must be evaluated continually through research for theirsafety, eﬀectiveness, eﬃciency, accessibility and quality.
7.

Medical research is subject to ethical standards that promote and ensure

respect for all human subjects and protect their health and rights.
8.

While the primary purpose of medical research is to generate new knowledge,

this goal can never take precedence over the rights and interests of individual
research subjects.
9.

It is the duty of physicians who are involved in medical research to protect thelife, health, dignity, integrity, right to self-determination, privacy, and conﬁdentiality of
personal information of research subjects. The responsibility for the protection ofresearch subjects must always rest with the physician or other health care
professionals and never with the research subjects, even though they have given
consent.
10.

Physicians must consider the ethical, legal and regulatory norms andstandards for research involving human subjects in their own countries as well as
applicable international norms and standards. No national or international ethical, legal
or regulatory requirement should reduce or eliminate any of the protections forresearch subjects set forth in this Declaration.
11.

Medical research should be conducted in a manner that minimises possible

harm to the environment.
12.

Medical research involving human subjects must be conducted only byindividuals with the appropriate ethics and scientiﬁc education, training and2/8

individuals with the appropriate ethics and scientiﬁc education, training andqualiﬁcations. Research on patients or healthy volunteers requires the supervision of acompetent and appropriately qualiﬁed physician or other health care professional.
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 therapeutic value and if the physician has good reason tobelieve that participation in the research study will not adversely aﬀect the health ofthe patients who serve as research subjects.
15.

Appropriate compensation and treatment for subjects who are harmed as aresult of participating in research must be ensured.

Risks, Burdens and Beneﬁts16.

In medical practice and in medical research, most interventions involve risksand burdens.
Medical research involving human subjects may only be conducted if theimportance of the objective outweighs the risks and burdens to the research subjects.
17.

All medical research involving human subjects must be preceded by carefulassessment of predictable risks and burdens to the individuals and groups involved in
the research in comparison with foreseeable beneﬁts to them and to other individuals
or groups aﬀected by the condition under investigation.
Measures to minimise the risks must be implemented. The risks must becontinuously monitored, assessed and documented by the researcher.
18.

Physicians may not be involved in a research study involving human subjects

unless they are conﬁdent that the risks have been adequately assessed and can besatisfactorily managed.
When the risks are found to outweigh the potential beneﬁts or when there isconclusive proof of deﬁnitive outcomes, physicians must assess whether to continue,
modify or immediately stop the study.

Vulnerable Groups and Individuals
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19.

Some groups and individuals are particularly vulnerable and may have an

increased likelihood of being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive speciﬁcally consideredprotection.
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 becarried out in a non-vulnerable group. In addition, this group should stand to beneﬁt
from the knowledge, practices or interventions that result from the research.

Scientiﬁc Requirements and Research Protocols
21.

Medical research involving human subjects must conform to generally

accepted scientiﬁc principles, be based on a thorough knowledge of the scientiﬁcliterature, other relevant sources of information, and adequate laboratory and, as
appropriate, animal 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 research protocol.
The protocol should contain a statement of the ethical considerations involved
and should indicate how the principles in this Declaration have been addressed. The
protocol should include information regarding funding, sponsors, institutionalaﬃliations, potential conﬂicts of interest, incentives for subjects and information
regarding provisions for treating and/or compensating subjects who are harmed as aconsequence of participation in the research study.
In clinical trials, the protocol must also describe appropriate arrangements forpost-trial provisions.

Research Ethics Committees
23.

The research protocol must be submitted for consideration, comment,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 researcher, 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 inwhich the research is to be performed as well as applicable international norms andstandards but these must not be allowed to reduce or eliminate any of the protections4/8

standards but these must not be allowed to reduce or eliminate any of the protections
for research subjects set forth in this Declaration.
The committee must have the right to monitor ongoing studies. The researchermust provide monitoring information to the 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 the study, theresearchers must submit a ﬁnal report to the committee containing a summary of thestudy’s ﬁndings and conclusions.

Privacy and Conﬁdentiality
24.

Every precaution must be taken to protect the privacy of research subjects

and the conﬁdentiality of their personal information.

Informed Consent25.

Participation by individuals capable of giving informed consent as subjects inmedical research must be voluntary. Although it 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 possible conﬂicts of interest, institutional aﬃliations of theresearcher, the anticipated beneﬁts and potential risks of the study and thediscomfort it may entail, post-study provisions and any other relevant aspects of thestudy. 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 reprisal. Special
attention should be given to the speciﬁc information needs of individual potential
subjects as well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, thephysician or another appropriately qualiﬁed individual must then seek the potential
subject’s freely-given informed consent, preferably in writing. If the consent cannot be
expressed in writing, the non-written consent must be formally documented andwitnessed.
All medical research subjects should be given the option of being informed
about the general outcome and results of the study.
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27.

When seeking informed consent for participation in a research study thephysician must be particularly cautious if the potential subject is in a dependent
relationship with the physician or may consent under duress. In such situations theinformed consent must be sought by an appropriately qualiﬁed individual who iscompletely independent of this relationship.
28.

For a potential research subject who is incapable of giving informed consent,

the physician must seek informed consent from the legally authorised representative.
These individuals must not be included in a research study that has no likelihood of
beneﬁt for them unless it is intended to promote the health of the group represented
by the potential subject, the research cannot instead be performed with persons
capable of providing informed consent, and the research entails only minimal risk andminimal burden.
29.

When a potential research subject who is deemed incapable of giving informed

consent is able to give assent to decisions about participation in research, thephysician must seek that assent in addition to the consent of the legally authorised
representative. The potential subject’s dissent should be respected.
30.

Research involving subjects who are physically or mentally incapable of giving

consent, for example, unconscious patients, may be done only if the physical ormental condition that prevents giving informed consent is a necessary characteristicof the research group. In such circumstances the physician must seek informed
consent from the legally authorised representative. If no such representative isavailable and if the research cannot be delayed, the study may proceed without
informed consent provided that the speciﬁc reasons for involving subjects with acondition that renders them unable to give informed consent have been stated in theresearch protocol and the study has been approved by a research ethics committee.
Consent to remain in the research must be obtained as soon as possible from thesubject or a legally authorised representative.
31.

The physician must fully inform the patient which aspects of their care arerelated to the research. The refusal of a patient to participate in a study or thepatient’s decision to withdraw from the study must never adversely aﬀect the patientphysician relationship.
32.

For medical research using identiﬁable human material or data, such as

research on material or data contained in biobanks or similar repositories, physiciansmust seek informed consent for its collection, storage and/or reuse. There may be
exceptional situations where consent would be impossible or impracticable to obtainfor such research. In such situations the research may be done only after

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for such research. In such situations the research 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 intervention must betested against those of the best proven intervention(s), except in the following
circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, isacceptable; orWhere for compelling and scientiﬁcally sound methodological reasons the useof any intervention less eﬀective than the best proven one, the use of placebo, or nointervention is necessary to determine the eﬃcacy or safety of an intervention
and the patients who receive any intervention less eﬀective than the best
proven one, placebo, or no intervention will not be subject 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.

In advance of a clinical trial, sponsors, researchers and host country

governments should make provisions for post-trial access for all participants who stillneed an intervention identiﬁed as beneﬁcial in the trial. This information must also bedisclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination ofResults
35.

Every research study involving human subjects must be registered in a publicly

accessible database before recruitment of the ﬁrst subject.
36.

Researchers, authors, sponsors, editors and publishers all have ethicalobligations with regard to the publication and dissemination of the results of research.
Researchers have a duty to make publicly available the results of their research on
human subjects and are accountable for the completeness and accuracy of theirreports. All parties should adhere to accepted guidelines for ethical reporting. Negativeand inconclusive as well as positive results must be published or otherwise madepublicly available. Sources of funding, institutional aﬃliations and conﬂicts of interest 7/8

publicly available. Sources of funding, institutional aﬃliations and conﬂicts of interest
must be declared in the publication. Reports of research not in accordance with theprinciples of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice37.

In the treatment of an individual patient, where proven interventions do notexist or other known interventions have been ineﬀective, the physician, after seeking
expert advice, with informed consent from the patient or a legally authorised
representative, may use an unproven intervention if in the physician's judgement it
oﬀers hope of saving life, re-establishing health or alleviating suﬀering. This
intervention should subsequently be made the object of research, designed toevaluate its safety and eﬃcacy. In all cases, new information must be recorded and,
where appropriate, made publicly available.

© World Medical Association, Inc. - All Rights reserved.
© Asociación médica mundial - Todos los derechos reservados.
© L'Association Médicale Mondiale - Tous droits réservés.

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