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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, June 1964 and amended by the 29th World Medical Assembly,
Tokyo, Japan, October 1975, 35th World Medical Assembly, Venice, Italy,
October 1983, 41st World Medical Assembly, Hong Kong, September 1989, and the
48th General Assembly, Somerset West, Republic of South Africa, October 1996 |
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Contents· II. MEDICIAL RESEARCH COMBINED WITH PROFESSIONAL CARE (Clinical
research) · III. NON-THERAPEUTIC BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (Non-clinical biomedical research) INTRODUCTION It is the
mission of the physician to safeguard the health of the people. His or her
knowledge and conscience are dedicated the fulfillment of this mission. The Declaration of Geneva of the World Medical Assembly
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, civic and ethical responsibilities
under the laws of their own countries. 1.
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. 2. 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. 3.
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. 4.
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. 5. Every
biomedical research 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 interest of the subject must always
prevail over the interests of science and society. 6. 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. 7.
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. 8. 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. 9. 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 a 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. 10. 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. 11. 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 consent, the minor's consent must be
obtained in addition to the consent of the minor's legal guardian. 12. 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 clinical care (Clinical
research) 1. 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 judgement it offers hope
of saving life, reestablishing health or alleviating suffering. 2. The
potential benefits, hazards and discomfort of a new method should be weighed
against the advantages of the best current diagnostic and therapeutic
methods. 3. 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. This does
not exclude the use of inert placebo in studies where no proven diagnostic or
threapeutic method exists. 4. The
refusal of the patient to participate in a study must never interfere with
the physician- patient relationship. 5. 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). 6. 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) 1. 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. 2. The
subject should be volunteers - either healthy persons or patients for whom the
experimental design is not related to the patient's illness. 3. The
investigator or the investigating team should discontinue the research if in
his/her or their judgement it may, if continued, be harmful to the
individual. 4. In
research on man, the interest of science and society should never take
precedence over considerations related to the well being of the subject. |