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7. ETHICAL ISSUES IN NEUROSCIENCE RESEARCH ON SUBSTANCE DEPENDENCE TREATMENT AND PREVENTION

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.

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