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「ヘルシンキ宣言第5版【1996年版】」


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last update: 20151221


ヘルシンキ宣言第5版【1996年版】

 *2000年6月7日に土屋貴志さんが米国食品医薬品局のホームページ(http://www.fda.gov/oc/oha/IRB/)からダウンロードしたものです。

World Medical Association Declaration of Helsinki: Recommendations Guiding M
edical 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, Octo
ber 1996

Introduction

It is the mission of the physician to safeguard the health of the people. H
is or her knowledge and conscience are dedicated the fulfillment of this mis
sion.

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,"an
d the International Code of Medical Ethics declares that, "A physician shall
act only in the patient's interest when providing medical care which might h
ave the effect of weakening the physical and mental condition of the patient."

The purpose of biomedical research involving human subjects must be to impro
ve diagnostic, therapeutic and prophylactic procedures and the understanding
of the aetiology and pathogenesis of disease.

In current medical practice most diagnostic, therapeutic or prophylactic pro
cedures 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 recogn
ized between medical research in which the aim is essentially diagnostic or
therapeutic for a patient, and medical research, the essential object of whi
ch is purely scientific and without implying direct diagnostic or therapeuti
c value to the person subjected to the research.

Special caution must be exercised in the conduct of research which may affec
t the environment, and the welfare of animals used for research must be resp
ected.

Because it is essential that the results of laboratory experiments be applie
d to human beings to further scientific knowledge and to help suffering huma
nity, the World Medical Association has prepared the following recommendatio
ns as a guide to every physician in biomedical research involving human subj
ects. 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 wo
rld. Physicians are not relieved from criminal,civic and ethical responsibi
lities under the laws of their own countries.

I. Basic Principles

1. Biomedical research involving human subjects must conform to generally ac
cepted scientific principles and should be based on adequately performed lab
oratory and animal experimentation and on a thorough knowledge of the scient
ific literature.

2. The design and performance of each experimental procedure involving human
subjects should be clearly formulated in an experimental protocol which shou
ld be transmitted for consideration, comment and guidance to a specially app
ointed committee independent of the investigator and the sponsor provided th
at 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 c
ompetent medical person. The responsibility for the human subject must alwa
ys rest with a medically qualified person and never rest on the subject of t
he research, even though the subject has given his or her consent.

4. Biomedical research involving human subjects cannot legitimately be carri
ed out unless the importance of the objective is in proportion to the inhere
nt risk to the subject.

5. Every biomedical research involving human subjects should be preceded by
careful assessment of predictable risks in comparison with foreseeable benef
its to the subject or to others. Concern for the interest of the subject mu
st 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 privac
y of the subject and to minimize the impact of the study on the subject's ph
ysical and mental integrity and on the personality of the subject.

7. Physicians should abstain from engaging in research projects involving hu
man subjects unless they are satisfied that the hazards involved are believe
d to be predictable. Physicians should cease any investigation if the hazar
ds are found to outweigh the potential benefits.

8. In publication of the results of his or her research, the physician is ob
liged to preserve the accuracy of the results. Reports of experimentation n
ot in accordance with the principles laid down in this Declaration should no
t be accepted for publication.

9. In any research on human beings, each potential subject must be adequatel
y 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 t
hat 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 s
hould 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 consen
t 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 th
at of the subject in accordance with national legislation.

Whenever the minor child is in fact able to give consent, the minor's consen
t 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 c
onsiderations 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 therapeuti
c 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,th
e specific reasons for this proposal should be stated in the experimental pr
otocol for transmission to the independent committee (I,2).

6. The physician can combine medical research with professional care, the ob
jective being the acquisition of new medical knowledge, only to the extent t
hat medical research is justified by its potential diagnostic or therapeutic
value for the patient.

III. Non-therapeutic biomedical research involving human subjects (Non-clini
cal 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 researc
h if in his/her or their judgement it may, if continued, be harmful to the i
ndividual.

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.


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