Página 225 - Dimensiones éticas de las regulaciones en salud

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ceboes or acceptable risk can prepare a committee for the kind of review
being advocated here.
The argument here may be illustrated with a discussion of the principle of
“harm reduction” in public health and public health research. Consider:
Harm reduction research is offered here as a morally acceptable
approach, but one that only can be undertaken when there are
good reasons to believe that the intervention (often a modification
of existing approaches) will be effective and good reasons to believe
that the intervention will reach those who need it. Harm reduc-
tion research will be troubling on many levels. Working within the
confines of extreme injustice, one must walk a fine like between
improving the situation and condoning it (7).
While this point is made at the level of public policy, it is only a few short
steps to the recognition that human subjects protection has as a matter
of policy been delegated to research ethics committees, and therefore that
these committees have duties beyond mere protocol review and the scru-
tiny of consent document “readability.” Moreover, it follows, effective
research ethics committee members and their institutions must therefore
provide adequately for education not just in the rules and regulations that
govern human subjects research – these committees must also be able to
assess and weigh the ethical issues raised by research proposals. Neither
Helsinki nor CIOMS nor the U.S. Code of Federal Regulations provides
any guidance in this regard.
How could they? The goals of law in civil society are in part to establish
rules of conduct and of conflict resolution; it is not usually the function of
legislatures to provide ethical decision procedures for the management of
issues that arise and for which there is no obvious legal resolution. The law
might say “do not discriminate,” but it remains for citizens to determine
the morality of affirmative action (for instance); the law might say “affirma-
tive action is required” or “affirmative action is permissible,” but it is the