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Oct 2000: Declaration of
Helsinki
WORLD MEDICAL ASSOCIATION DECLARATION OF
HELSINKI
The Helsinki Declaration in Norwegian
Ethical Principles for Medical Research Involving Human Subjects
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and
amended by the:
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29th WMA General Assembly, Tokyo, Japan, October 1975,
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35th WMA General Assembly, Venice, Italy, October 1983,
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41st WMA General Assembly, Hong Kong, September 1989,
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48th WMA General Assembly, Somerset West, Republic of South Africa, October
1996, and the
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52nd WMA General Assembly, Edinburgh, Scotland, October 2000.
A. INTRODUCTION
1.
The World Medical Association has developed the Declaration of Helsinki as a
statement of ethical principles to provide guidance to physicians and other
participants in medical research involving human subjects. Medical research
involving human subjects includes research on identifiable human material or
identifiable data.
2.
It is the duty of the physician to promote and safeguard the health of the
people. The physician's knowledge and conscience are dedicated to the
fulfillment (sic) of this duty.
3.
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."
4.
Medical progress is based on research which ultimately must rest in part on
experimentation involving human subjects.
5.
In medical research on human subjects, considerations related to the
well-being of the human subject should take precedence over the interests of
science and society.
6.
The primary purpose of medical research involving human subjects is to
improve prophylactic, diagnostic and therapeutic procedures and the
understanding of the aetiology and pathogenesis of disease. Even the best
proven prophylactic, diagnostic, and therapeutic methods must continuously
be challenged through research for their effectiveness, efficiency,
accessibility and quality.
7.
In current medical practice and in medical research, most prophylactic,
diagnostic and therapeutic procedures involve risks and burdens.
8.
Medical research is subject to ethical standards that promote respect for
all human beings and protect their health and rights. Some research
populations are vulnerable and need special protection. The particular needs
of the economically and medically disadvantaged must be recognized. Special
attention is also required for those who cannot give or refuse consent for
themselves, for those who may be subject to giving consent under duress, for
those who will not benefit personally from the research and for those for
whom the research is combined with care.
9.
Research Investigators should be aware of the ethical, legal and regulatory
requirements for research on human subjects in their own countries as well
as applicable international requirements. No national ethical, legal or
regulatory requirement should be allowed to reduce or eliminate any of the
protections for human subjects set forth in this Declaration.
B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH
10.
It is the duty of the physician in medical research to protect the life,
health, privacy, and dignity of the human subject.
11.
Medical research involving human subjects must conform to generally accepted
scientific principles, be based on a thorough knowledge of the scientific
literature, other relevant sources of information, and on adequate
laboratory and, where appropriate, animal experimentation.
12.
Appropriate 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.
13.
The design and performance of each experimental procedure involving human
subjects should be clearly formulated in an experimental protocol. This
protocol should be submitted for consideration, comment, guidance, and where
appropriate, approval to a specially appointed ethical review committee,
which must be independent of the investigator, the sponsor or any other kind
of undue influence. This independent committee should be in conformity with
the laws and regulations of the country in which the research experiment is
performed. The committee has the right to monitor ongoing trials. The
researcher has the obligation to provide monitoring information to the
committee, especially any serious adverse events. The researcher should also
submit to the committee, for review, information regarding funding,
sponsors, institutional affiliations, other potential conflicts of interest
and incentives for subjects.
14.
The research protocol should always contain a statement of the ethical
considerations involved and should indicate that there is compliance with
the principles enunciated in this Declaration.
15.
Medical 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 consent.
16.
Every medical research project involving human subjects should be preceded
by careful assessment of predictable risks and burdens in comparison with
foreseeable benefits to the subject or to others. This does not preclude the
participation of healthy volunteers in medical research. The design of all
studies should be publicly available.
17.
Physicians should abstain from engaging in research projects involving human
subjects unless they are confident that the risks involved have been
adequately assessed and can be satisfactorily managed. Physicians should
cease any investigation if the risks are found to outweigh the potential
benefits or if there is conclusive proof of positive and beneficial results.
18.
Medical research involving human subjects should only be conducted if the
importance of the objective outweighs the inherent risks and burdens to the
subject. This is especially important when the human subjects are healthy
volunteers.
19.
Medical research is only justified if there is a reasonable likelihood that
the populations in which the research is carried out stand to benefit from
the results of the research.
20.
The subjects must be volunteers and informed participants in the research
project.
21.
The right of research subjects to safeguard their integrity must always be
respected. Every precaution should be taken to respect the privacy of the
subject, the confidentiality of the patient's information and to minimize
the impact of the study on the subject's physical and mental integrity and
on the personality of the subject.
22.
In any research on human beings, each potential subject must be adequately
informed of the aims, methods, sources of funding, any possible conflicts of
interest, institutional affiliations of the researcher, the anticipated
benefits and potential risks of the study and the discomfort it may entail.
The subject should be informed of the right to abstain from participation in
the study or to withdraw consent to participate at any time without
reprisal. After ensuring that the subject has understood the information,
the physician should then obtain the subject's freely-given informed
consent, preferably in writing. If the consent cannot be obtained in
writing, the non-written consent must be formally documented and witnessed.
23.
When obtaining informed consent for the research project the physician
should be particularly cautious if the subject is in a dependent
relationship with the physician or may consent under duress. In that case
the informed consent should be obtained by a well-informed physician who is
not engaged in the investigation and who is completely independent of this
relationship.
24.
For a research subject who is legally incompetent, physically or mentally
incapable of giving consent or is a legally incompetent minor, the
investigator must obtain informed consent from the legally authorized
representative in accordance with applicable law. These groups should not be
included in research unless the research is necessary to promote the health
of the population represented and this research cannot instead be performed
on legally competent persons.
25.
When a subject deemed legally incompetent, such as a minor child, is able to
give assent to decisions about participation in research, the investigator
must obtain that assent in addition to the consent of the legally authorized
representative.
26.
Research on individuals from whom it is not possible to obtain consent,
including proxy or advance consent, should be done only if the
physical/mental condition that prevents obtaining informed consent is a
necessary characteristic of the research population. The specific reasons
for involving research subjects with a condition that renders them unable to
give informed consent should be stated in the experimental protocol for
consideration and approval of the review committee. The protocol should
state that consent to remain in the research should be obtained as soon as
possible from the individual or a legally authorized surrogate.
27.
Both authors and publishers have ethical obligations. In publication of the
results of research, the investigators are obliged to preserve the accuracy
of the results. Negative as well as positive results should be published or
otherwise publicly available. Sources of funding, institutional affiliations
and any possible conflicts of interest should be declared in the
publication. Reports of experimentation not in accordance with the
principles laid down in this Declaration should not be accepted for
publication.
C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE
28.
The physician may combine medical research with medical care, only to the
extent that the research is justified by its potential prophylactic,
diagnostic or therapeutic value. When medical research is combined with
medical care, additional standards apply to protect the patients who are
research subjects.
29.
The benefits, risks, burdens and effectiveness of a new method should be
tested against those of the best current prophylactic, diagnostic, and
therapeutic methods. This does not exclude the use of placebo, or no
treatment, in studies where no proven prophylactic, diagnostic or
therapeutic method exists.
30.
At the conclusion of the study, every patient entered into the study should
be assured of access to the best proven prophylactic, diagnostic and
therapeutic methods identified by the study.
31.
The physician should fully inform the patient which aspects of the care are
related to the research. The refusal of a patient to participate in a study
must never interfere with the patient-physician relationship.
32.
In the treatment of a patient, where proven prophylactic, diagnostic and
therapeutic methods do not exist or have been ineffective, the physician,
with informed consent from the patient, must be free to use unproven or new
prophylactic, diagnostic and therapeutic measures, if in the physician's
judgement it offers hope of saving life, re-establishing health or
alleviating suffering. Where possible, these measures should be made the
object of research, designed to evaluate their safety and efficacy. In all
cases, new information should be recorded and, where appropriate, published.
The other relevant guidelines of this Declaration should be followed. |
