WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Ethical Principles for Medical Research Involving Human Subjects
Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended
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
- 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
- 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 fulfilment
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
- 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 and quality.
- 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.
B. 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 subject.
- 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
- 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 results.
- 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
- 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
- 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
- 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.
C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE
- 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 research subjects.
- 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.
- 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.
- 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 followed.