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Helsingforsdeklarationen
World Medical Association Declaration of Helsinki, October 1996Introduction
It is the mission of the physician to safeguard the health of the people. His
or her knowledge and conscience are dedicated to the fulfilment 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, re-establishing 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.
This does not exclude the use of inert placebo in studies where no proven diagnostic
or therapeutic method exists.
- 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 (1, 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 subject 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.
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