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.