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NEUROSCIENCE OF PSYCHOACTIVE SUBSTANCE USE AND DEPENDENCE

BOX 7.1

Declaration of Helsinki 1
Ethical principles for medical research involving human subjects
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 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.

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