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Helsinki Declaration (1964): Augsburg IRB
WORLD MEDICAL ASSOCIATION DECLARATION OF
HELSINKI
Adopted by the 18th World
Medical Assembly, Helsinki, Finland, June 1964. Amended by the
29th World Medical Assembly, Tokyo, Japan, October 1975; 35th
World Medical Assembly, Venice, Italy, October 1983; and the 41st
World Medical Assembly, Hong Kong, September 1989.
0.
Introduction
I.
Basic Principles
II.
Medical Research Combined with Clinical
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 to 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, 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 Clinical 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.
TEXT PROVIDED BY University of
Michigan Medical IRB
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