medical doctors in biomedical
research involving human subjects
Adopted by the 18th World Medical Assembly, Helsinki,
Finland, 1964 and As Revised by the 29th World Medical Assembly,
Tokyo, Japan, 1975.
It is the mission of the medical doctor 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 doctor with the world, "The health of my patient will be
my first consideration," 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
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
In current medical practice most diagnostic, therapeutic or
prophylactic procedures involve hazards. This applies a
fortiori 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 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 doctor in biomedical research involving human subjects. They
should be kept under review in the future. lt 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 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 to a specially
appointed independent committee for consideration, comment and
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 project involving human subjects
should be preceded by careful assessment of predictable risks in
comparison with forseeable benefits to the subject or to others.
Concern for the interests of the subject must always prevail over
the interest 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
8. In publication of the results of his or her research, the
doctor 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 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 freelygiven
informed consent, preferably in writing.
10. When obtaining informed consent for the research project
the doctor 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 doctor 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.
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 Professional
1. In the treatment of the sick person, the doctor 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
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.
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 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
(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 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 healthy persons
or patients for whom the experimental design is not related to the
3. 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.
4. In research on man, the interest of science and society
should never take precedence over considerations related to the
wellbeing of the