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.
Introduction
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 of disease.
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 subjects.
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 countries.
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 publication.
- 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 (Clinical
Research)
- 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 relationship.
- 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
the patient.
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.
Return to FDA
Information Sheets
FDA Home Page | Search
| A-Z Index | Site
Map | Contact FDA
FDA/Website
Management Staff
Web page updated by clb
2001-MAR-08.