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NEUROSCIENCE OF PSYCHOACTIVE SUBSTANCE USE AND DEPENDENCE

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/

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