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

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.

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