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,
and the 52nd WMA General Assembly, Edinburgh, Scotland, October
Note of Clarification on Paragraph 29 added by the WMA General
Assembly, Washington 2002
Note of Clarification on Paragraph 30 added by the WMA General
Assembly, Tokyo 2004
- The World Medical Association has developed the Declaration
of Helsinki as a statement of ethical principles to provide
guidance to physicians and other participants in medical
research involving human subjects. Medical research involving
human subjects includes research on identifiable human material
or identifiable data.
- It is the duty of the physician to promote and safeguard
the health of the people. The physician's knowledge and
conscience are dedicated to the fulfillment of this duty.
- The Declaration of Geneva of the World Medical Association
binds the physician with the words, "The health of
my patient will be my first consideration," and the
International Code of Medical Ethics declares that, "A
physician shall act only in the patient's interest when
providing medical care which might have the effect of weakening
the physical and mental condition of the patient."
- Medical progress is based on research which ultimately
must rest in part on experimentation involving human subjects.
- In medical research on human subjects, considerations
related to the well-being of the human subject should take
precedence over the interests of science and society.
- The primary purpose of medical research involving human
subjects is to improve prophylactic, diagnostic and therapeutic
procedures and the understanding of the aetiology and pathogenesis
of disease. Even the best proven prophylactic, diagnostic,
and therapeutic methods must continuously be challenged
through research for their effectiveness, efficiency, accessibility
- In current medical practice and in medical research,
most prophylactic, diagnostic and therapeutic procedures
involve risks and burdens.
- Medical research is subject to ethical standards that
promote respect for all human beings and protect their health
and rights. Some research populations are vulnerable and
need special protection. The particular needs of the economically
and medically disadvantaged must be recognized. Special
attention is also required for those who cannot give or
refuse consent for themselves, for those who may be subject
to giving consent under duress, for those who will not benefit
personally from the research and for those for whom the
research is combined with care.
- Research Investigators should be aware of the ethical,
legal and regulatory requirements for research on human
subjects in their own countries as well as applicable international
requirements. No national ethical, legal or regulatory requirement
should be allowed to reduce or eliminate any of the protections
for human subjects set forth in this Declaration.
- BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH
- It is the duty of the physician in medical research to
protect the life, health, privacy, and dignity of the human
- Medical research involving human subjects must conform
to generally accepted scientific principles, be based on
a thorough knowledge of the scientific literature, other
relevant sources of information, and on adequate laboratory
and, where appropriate, animal experimentation.
- Appropriate caution must be exercised in the conduct of
research which may affect the environment, and the welfare
of animals used for research must be respected.
- The design and performance of each experimental procedure
involving human subjects should be clearly formulated in
an experimental protocol. This protocol should be submitted
for consideration, comment, guidance, and where appropriate,
approval to a specially appointed ethical review committee,
which must be independent of the investigator, the sponsor
or any other kind of undue influence. This independent committee
should be in conformity with the laws and regulations of
the country in which the research experiment is performed.
The committee has the right to monitor ongoing trials. The
researcher has the obligation to provide monitoring information
to the committee, especially any serious adverse events.
The researcher should also submit to the committee, for
review, information regarding funding, sponsors, institutional
affiliations, other potential conflicts of interest and
incentives for subjects.
- The research protocol should always contain a statement
of the ethical considerations involved and should indicate
that there is compliance with the principles enunciated
in this Declaration.
- Medical research involving human subjects should be conducted
only by scientifically qualified persons and under the supervision
of a clinically competent medical person. The responsibility
for the human subject must always rest with a medically
qualified person and never rest on the subject of the research,
even though the subject has given consent.
- Every medical research project involving human subjects
should be preceded by careful assessment of predictable
risks and burdens in comparison with foreseeable benefits
to the subject or to others. This does not preclude the
participation of healthy volunteers in medical research.
The design of all studies should be publicly available.
- Physicians should abstain from engaging in research projects
involving human subjects unless they are confident that
the risks involved have been adequately assessed and can
be satisfactorily managed. Physicians should cease any investigation
if the risks are found to outweigh the potential benefits
or if there is conclusive proof of positive and beneficial
- Medical research involving human subjects should only
be conducted if the importance of the objective outweighs
the inherent risks and burdens to the subject. This is especially
important when the human subjects are healthy volunteers.
- Medical research is only justified if there is a reasonable
likelihood that the populations in which the research is
carried out stand to benefit from the results of the research.
- The subjects must be volunteers and informed participants
in the research project.
- The right of research subjects to safeguard their integrity
must always be respected. Every precaution should be taken
to respect the privacy of the subject, the confidentiality
of the patient's information and to minimize the impact
of the study on the subject's physical and mental integrity
and on the personality of the subject.
- In any research on human beings, each potential subject
must be adequately informed of the aims, methods, sources
of funding, any possible conflicts of interest, institutional
affiliations of the researcher, the anticipated benefits
and potential risks of the study and the discomfort it may
entail. The subject should be informed of the right to abstain
from participation in the study or to withdraw consent to
participate at any time without reprisal. After ensuring
that the subject has understood the information, the physician
should then obtain the subject's freely-given informed consent,
preferably in writing. If the consent cannot be obtained
in writing, the non-written consent must be formally documented
- When obtaining informed consent for the research project
the physician should be particularly cautious if the subject
is in a dependent relationship with the physician or may
consent under duress. In that case the informed consent
should be obtained by a well-informed physician who is not
engaged in the investigation and who is completely independent
of this relationship.
- For a research subject who is legally incompetent, physically
or mentally incapable of giving consent or is a legally
incompetent minor, the investigator must obtain informed
consent from the legally authorized representative in accordance
with applicable law. These groups should not be included
in research unless the research is necessary to promote
the health of the population represented and this research
cannot instead be performed on legally competent persons.
- When a subject deemed legally incompetent, such as a
minor child, is able to give assent to decisions about participation
in research, the investigator must obtain that assent in
addition to the consent of the legally authorized representative.
- Research on individuals from whom it is not possible
to obtain consent, including proxy or advance consent, should
be done only if the physical/mental condition that prevents
obtaining informed consent is a necessary characteristic
of the research population. The specific reasons for involving
research subjects with a condition that renders them unable
to give informed consent should be stated in the experimental
protocol for consideration and approval of the review committee.
The protocol should state that consent to remain in the
research should be obtained as soon as possible from the
individual or a legally authorized surrogate.
- Both authors and publishers have ethical obligations.
In publication of the results of research, the investigators
are obliged to preserve the accuracy of the results. Negative
as well as positive results should be published or otherwise
publicly available. Sources of funding, institutional affiliations
and any possible conflicts of interest should be declared
in the publication. Reports of experimentation not in accordance
with the principles laid down in this Declaration should
not be accepted for publication.
- ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH
- The physician may combine medical research with medical
care, only to the extent that the research is justified
by its potential prophylactic, diagnostic or therapeutic
value. When medical research is combined with medical care,
additional standards apply to protect the patients who are
- The benefits, risks, burdens
and effectiveness of a new method should be tested against
those of the best current prophylactic, diagnostic, and
therapeutic methods. This does not exclude the use of placebo,
or no treatment, in studies where no proven prophylactic,
diagnostic or therapeutic method exists. See
- At the conclusion
of the study, every patient entered into the study should
be assured of access to the best proven prophylactic, diagnostic
and therapeutic methods identified by the study. See
- The physician should fully inform the patient which aspects
of the care are related to the research. The refusal of
a patient to participate in a study must never interfere
with the patient-physician relationship.
- In the treatment of a patient, where proven prophylactic,
diagnostic and therapeutic methods do not exist or have
been ineffective, the physician, with informed consent from
the patient, must be free to use unproven or new prophylactic,
diagnostic and therapeutic measures, if in the physician's
judgement it offers hope of saving life, re-establishing
health or alleviating suffering. Where possible, these measures
should be made the object of research, designed to evaluate
their safety and efficacy. In all cases, new information
should be recorded and, where appropriate, published. The
other relevant guidelines of this Declaration should be
Note: Note of clarification on
paragraph 29 of the WMA Declaration of Helsinki
The WMA hereby reaffirms its position that extreme care must
be taken in making use of a placebo-controlled trial and that
in general this methodology should only be used in the absence
of existing proven therapy. However, a placebo-controlled trial
may be ethically acceptable, even if proven therapy is available,
under the following circumstances:
- Where for compelling and scientifically sound methodological
reasons its use is necessary to determine the efficacy or safety
of a prophylactic, diagnostic or therapeutic method; or
- Where a prophylactic, diagnostic or therapeutic
method is being investigated for a minor condition and the patients
who receive placebo will not be subject to any additional risk
of serious or irreversible harm.
All other provisions of the Declaration of Helsinki must be adhered
to, especially the need for appropriate ethical and scientific
Page back to paragraph 29.
Note: Note of clarification on
paragraph 30 of the WMA Declaration of Helsinki
The WMA hereby reaffirms its position that it is necessary during
the study planning process to identify post-trial access by study
participants to prophylactic, diagnostic and therapeutic procedures
identified as beneficial in the study or access to other appropriate
care. Post-trial access arrangements or other care must be described
in the study protocol so the ethical review committee may consider
such arrangements during its review.
Page back to paragraph 30.
The Declaration of Helsinki (Document
17.C) is an official policy document of the World Medical Association,
the global representative body for physicians. It was first adopted
in 1964 (Helsinki, Finland) and revised in 1975 (Tokyo, Japan),
1983 (Venice, Italy), 1989 (Hong Kong), 1996 (Somerset-West, South
Africa) and 2000 (Edinburgh, Scotland). Note of clarification
on Paragraph 29 added by the WMA General Assembly, Washington