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NEUROSCIENCE OF PSYCHOACTIVE SUBSTANCE USE AND DEPENDENCE

Distributive justice
Justice and the criteria for sound clinical trials both require that a represen-
tative sample of the population at risk is recruited into such studies (Brody,
1998). Special efforts may need to be made to ensure that women, children
and minority groups are included in clinical trials to ensure that they have
access to the benefits of research participation and that the results of research
studies can be applied to these groups if drugs that are trialed are eventually
approved and registered for clinical use (Brody, 1998).

Conflicts of interest
An ethical issue of increasing significance, given the extent of funding of
clinical trials by pharmaceutical companies, is ensuring public confidence
in the results (Davidoff et al., 2001; DeAngelis, Fontanarosa & Flanagin, 2001).
Public trust has been undermined in recent years because investigators have
failed to disclose their personal financial interests in the outcomes of clinical
trials (e.g. as a result of being paid large consultancy fees for promoting
pharmaceuticals or shares in a pharmaceutical company). This has become
an increasingly larger problem as public funding for medical research and
universities has declined and pharmaceutical companies have become a
major source of research funds. Moreover, research funded by these
companies has been conducted by contract research organizations, with the
conditions in which data can be published being controlled by
pharmaceutical sponsors (DeAngelis, Fontanarosa & Flanagin, 2001; Anon,
2001).
No matter how scientifically rigorous and ethically conducted a study may
be, its findings are of limited use if the public does not have confidence in
their validity (Davidoff et al., 2001; DeAngelis, Fontanarosa & Flanagin, 2001).
A number of policies have been implemented by editors of leading medical
journals in an effort to restore trust in clinical research. One is the decision
by these editors to require that authors disclose funding sources and potential
conflicts of interest, and assert that they have had complete control over the
study data and their analysis (Davidoff et al., 2001; DeAngelis, Fontanarosa
& Flanagin, 2001). Another policy has been the creation of a register of clinical
trial protocols before the start of the study to minimize the suppression of
unfavourable results or ex post facto selection of results and methods of
analysis in order to make a drug look its best (Horton, 1997).
Additional policy recommendations have been made that have not so far
been implemented. These include: independent monitoring of compliance
with the study protocol, especially with reporting of any adverse events
experienced by participants; and a requirement that investigators and the
sponsors of a trial commit to publishing its results within two years of
completing data collection, as a condition of the study protocol being
approved by an ethics committee (Reidenberg, 2001). The latter seems well

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