The World Medical Association
Declaration of Helsinki
World Medical Association Declaration of Helsinki: Recommendations Guiding Medical
Doctors in Biomedical Research Involving Human Subjects
Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and as
revised by the World Medical Assembly in Tokyo, Japan in 1975, in Venice, Italy
in 1983, and in Hong Kong in 1989.
It is the mission of the physician
to safeguard the health of the people. His or her knowledge and conscience are
dedicated to the fulfillment of this mission.
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."
The Purpose of biomedical research
involving human subjects must be to improve diagnostic, therapeutic and
prophylactic procedures and the understanding of the aetiology and pathogenesis
In current medical practice most
diagnostic, therapeutic or prophylactic procedures involve hazards. This
applies especially to biomedical research.
Medical progress is based on
research which ultimately must rest in part on experimentation involving human
In the field of biomedical research
a fundamental distinction must be recognized between medical research in which
the aim is essentially diagnostic or therapeutic for a patient, and medical research,
the essential object of which is purely scientific and without implying direct
diagnostic or therapeutic value to the person subjected to the research.
Special 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.
Because it is essential that the
results of laboratory experiments be applied to human beings to further
scientific knowledge and to help suffering humanity, the World Medical
Association has prepared the following recommendations as a guide to every
physician in biomedical research involving human subjects. They should be kept
under review in the future. It must be stressed that the standards as drafted
are only a guide to physicians all over the world. Physicians are not relieved
from criminal, civil and ethical responsibilities under the laws of their own
I. Basic Principles
- Biomedical research involving
human subjects must conform to generally accepted scientific principles and
should be based on adequately performed laboratory and animal
experimentation and on a thorough knowledge of the scientific literature.
- The design and performance of
each experimental procedure involving human subjects should be clearly
formulated in an experimental protocol which should be transmitted for
consideration, comment and guidance to a specially appointed committee
independent of the investigator and the sponsor provided that this
independent committee is in conformity with the laws and regulations of
the country in which the research experiment is performed.
- Biomedical 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 his or her consent.
- Biomedical research involving
human subjects cannot legitimately be carried out unless the importance of
the objective is in proportion to the inherent risk to the subject.
- Every biomedical research
project involving human subjects should be preceded by careful assessment
of predictable risks in comparison with foreseeable benefits to the
subject or to others. Concern for the interests of the subject must always
prevail over the interests of science and society.
- The right of the research
subject to safeguard his or her integrity must always be respected. Every
precaution should be taken to respect the privacy of the subject and to
minimize the impact of the study on the subject's physical and mental
integrity and on the personality of the subject.
- Physicians should abstain
from engaging in research projects involving human subjects unless they
are satisfied that the hazards involved are believed to be predictable.
Physicians should cease any investigation if the hazards are found to
outweigh the potential benefits.
- In publication of the results
of his or her research, the physician is obliged to preserve the accuracy
of the results. Reports of experimentation not in accordance with the
principles laid down in this Declaration should not be accepted for
- In any research on human
beings, each potential subject must be adequately informed of the aims,
methods, anticipated benefits and potential hazards of the study and the
discomfort it may entail. He or she should be informed that he or she is
at liberty to abstain from participation in the study and that he or she is
free to withdraw his or her consent to participation at any time. The
physician should then obtain the subject's freely-given informed consent,
preferably in writing.
- When obtaining informed
consent for the research project the physician should be particularly
cautious if the subject is in a dependent relationship to him or her or
may consent under duress. In that case the informed consent should be
obtained by a physician who is not engaged in the investigation and who is
completely independent of this official relationship.
- In case of legal
incompetence, informed consent should be obtained from the legal guardian
in accordance with national legislation. Where physical or mental
incapacity makes it impossible to obtain informed consent, or when the
subject is a minor, permission from the responsible relative replaces that
of the subject in accordance with national legislation. Whenever the minor
child is in fact able to give a consent, the minor's consent must be
obtained in addition to the consent of the minor's legal guardian.
- The research protocol should
always contain a statement of the ethical considerations involved and
should indicate that the principles enunciated in the present Declaration
are complied with.
II. Medical Research Combined with Professional Care
- In the treatment of the sick
person, the physician must be free to use a new diagnostic and therapeutic
measure, if in his or her judgment it offers hope of saving life,
reestablishing health or alleviating suffering.
- The potential benefits,
hazards and discomfort of a new method should be weighed against the
advantages of the best current diagnostic and therapeutic methods.
- In any medical study, every
patient--including those of a control group, if any--should be assured of
the best proven diagnostic and therapeutic method.
- The refusal of the patient to
participate in a study must never interfere with the physician-patient
- If the physician considers it
essential not to obtain informed consent, the specific reasons for this
proposal should be stated in the experimental protocol for transmission to
the independent committee (I,2).
- The physician can combine
medical research with professional care, the objective being the
acquisition of new medical knowledge, only to the extent that medical
research is justified by its potential diagnostic or therapeutic value for
III. Non-Therapeutic Biomedical Research Involving Human
Subjects (Non-Clinical Biomedical Research)
- In the purely scientific
application of medical research carried out on a human being, it is the
duty of the physician to remain the protector of the life and health of
that person on whom biomedical research is being carried out.
- The subjects should be
volunteers--either healthy persons or patients for whom the experimental
design is not related to the patient's illness.
- The investigator or the
investigating team should discontinue the research if in his/her or their
judgment it may, if continued, be harmful to the individual.
- In research on man, the
interest of science and society should never take precedence over
considerations related to the well-being of the subject.