Wits Bioethics Resources - Declaration of Helsinki
Initiated: 1964 17.C
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Ethical Principles for Medical Research Involving Human Subjects
Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended
by the 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General
Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong,
September 1989 48th WMA General Assembly, Somerset West, Republic of South Africa,
October 1996 and the 52nd WMA General Assembly, Edinburgh, Scotland, October
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
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 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
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
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.
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.
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.
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.
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.
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.
§ § § 7.10.2000 09h14