Declaration of Helsinki
Recommendations guiding medical doctors in biomedical research involving human subjects
Adopted by the Eighteenth World Medical Assem-
bly, Helsinki, Finland, 1964, and revised by the
Twenty-ninth World Medical Assembly; Tokyo,
Japan, 1975
Introduction
It is the mission of the medical doctor to safe-
guard the health of the people. His or her knowled-
ge and conscience are dedicated to the fulfilment
of this mission.
The Declaration of Geneva of the World Medical
Association binds the doctor with the words,
"The health of my patient will be my first conside-
ration", and the International Code of Medical
Ethics declares that, "Any act or advice which
could weaken physical or mental resistance of a
human being may be used only in his interest."
The purpose of biopredical research involving
human subjects must be to improve diagnostic,
therapeutic and prophylactic procedures and the
understanding of the etiology and pathogenesis
of disease.
In current medical practice most diagnostic,
therapeutic or prophylactic procedures involve
hazards. This applies
a fortiori
to biomedical re-
search.
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 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 labora-
tory experiments be applied to human beings to
further scientific knowledge and to help suffering
humanity, the World Medical Association has
prepared the following recomendations as a guide to
every doctor 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. Doctors are not relieved from criminal,
civil and ethical responsibilities under the laws of
their own countries.
I. Basic principles
1. Biomedical research involving human subjects
must conform to generally accepted scientific
principles and should be based on adequately per-
formed laboratory and animal experimentation
and on a thorough knowledge of the scientific
literature.
2. The design and performance of eachexperimen-
tal procedure involving human subjects should
be dearly formulated in an experimental protocol
which should be transmitted to a specially appointed
independent committee for consideration, comment
and guidance.
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 me-
dically qualified person and never rest on the sub-
ject 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 impor-
tance of the objective is in proportion to the inhe-
rent risk to the subject.
5. 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 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. Doctors should abstain from engaging in research
projects involving human subjects unless they are
satisfied that the hazards involved are believed
to be predictable. Doctors should cease any
investigation if the hazards are found to outweigh
the potential benefits.
8. In publication of the results of his or her re-
search, the doctor is obliged to preserve the accura-
cy of the results. Reports on 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 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 doctor
should then obtain the subject s freely-given in-
formed consent, preferably in writing.
10. When obtaining informed consent for the re-
search project
the doctor should be particularly
cautious if the subject is in a dependent re-
lationship
to him or her or may consent
under duress. In that case the informed consent
should be obtained by a doctor who is not engaged
in the investigation and who is completely indepen-
dent of this official relationship.
11. In the case of legal incompetence informed
consent should be obtained from the legal guardian
in accordance with national legislation.Wherephysi-
cal 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.
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.
11. Medical research combined with professional care
(clinical research)
I. In the treatment of the sick person, the doctor
must be free to use a new diagnostic and thera-
peutic measure, if in his or her judgement it offers
hope of saving life, reestablishing health or allevi-
ating suffering.
2. The potential benefits, hazards and discomfort
of a new method should be weighed against the
advantages of the best current diagnostic and thera-
peutic 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.
4. The refusal of the patient to participate in a
study must never interfere with the doctor-patient
relationship.
5. If the doctor 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).
6. The doctor can combine medical research with
professional care, the objective being the acquisi-
tion of new medical knowledge, only to the extent
that medical research is justified by its potential
diagnostic or therapeutic value for the patient.
Ill. Non-therapeutic biomedical research involving
human subjects (non-clinical biomedical research)
1.1n the purely scientific application of medical
research carried out on a human being, it is the duty
of the doctor to remain the protector of the life
and health of that person on whom biomedical
research is being carried out.
2. The subjects should be volunteers--either heal-
thy persons or patients for whom the experimental
design is not related to the patient s illness.
3. The investigator or the investigating tear
discontinue the research if in his/her or their judge-
ment it may, if continued, be harmful to the indivi-
dual.
4. In research on man, the interest of science and
society should never take precedence over conside-
rations related to the well-being of the subject.
Cermin Dunia Kedokteran No. 25, 1982
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