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

entry, and fear of return to prison as a reason for complying with drug
treatment. Offenders should have a constrained choice as to whether they
take up treatment or not, and, if they choose to do so, they should be able to
choose from a range of treatment options. Moreover, the process should be
subject to judicial oversight and review.
If drug immunotherapies and pharmacological treatments are used under
legal coercion, their safety, effectiveness and cost-effectiveness should be
rigorously evaluated (National Research Council, 2001). Any such use should
be cautiously trialed and evaluated, and only after considerable experience
has been acquired in their therapeutic use with voluntary patients.

Summary and conclusions
Substance dependence is a serious personal and public health issue
throughout the world. Many forms of substance dependence are difficult to
treat because of a lack of effective psychosocial or pharmacological
treatments.
Experimental studies on humans of the neurobiological basis of substance
dependence raise a number of ethical issues, one of which is the capacity of
dependent persons to give their consent to participate in such studies. As
long as participants are not intoxicated or suffering acute withdrawal
symptoms at the time they give consent, there is no compelling reason for
believing that persons who are substance dependent cannot give free and
informed consent. The risks of administration of drugs, and the use of
neuroimaging methods in these experiments, generally do not pose a serious
risk to participants.
The ethical issues raised by clinical trials of new pharmacotherapies have
been extensively debated and a consensus has evolved on the conditions that
must be met. These include free and informed consent, an acceptable risk–
benefit ratio, and protection of participant privacy and confidentiality. Trials
with substance dependent persons require special attention to informed
consent in order to ensure that persons are not intoxicated or experiencing
withdrawal symptoms when deciding to participate in trials. Placebo
comparisons may be ethically acceptable in such trials if there is no effective
pharmacotherapy and if participants are also offered good quality
psychosocial care.
Preventive pharmacological interventions for substance dependence do
not yet exist and are likely to be highly controversial if they are developed. It
is a possibility that may loom larger in the future with the development of
interventions that have a potential preventive use, foremost among which
are drug immunotherapies. The ethical issues raised by these approaches
need to be debated now. The risks of stigmatization and discrimination that
are raised by any preventive intervention that identifies high-risk subjects
will need to be dealt with. So too will issues of consent in minors, and the
potential risks to participants of immunological interventions.

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