Página 223 - Dimensiones éticas de las regulaciones en salud

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Rather, the concern is not with regulation as such – it is that we are losing
sight of the fact that regulations and laws are (and generally ought to be)
based on shared morality and values, and not even the must nuanced and
adaptive legal system can anticipate all future circumstances. In the same
way that medical education cannot consist in detailed instructions for the
management of individual future cases, training for human subjects pro-
tection cannot include detailed instructions for the review of future ex-
perimental protocols and studies. Rather, in both cases, educators succeed
when they provide learners with the tools of critical analysis.
In what follows, we examine this “ethics education imperative” in light
of three contemporary issues in human subjects research: Health priority
setting, conflicts of interest and vulnerable populations. The overarching
point is that each of these issues poses important challenges for research
ethics committees – challenges not amenable to or easily addressed by
even the best-intentioned and well-reasoned laws and regulations. If this
point is made adequately, it will follow that research ethics committees
need to include … well, ethics, as part of the training of members.
Health priorities
The growth of interest in, research addressing, and debate about prior-
ity setting in the developing world is a noteworthy and positive develop-
ment. The priority-setting literature has, for instance, addressed the role
evidence-based practice(1), financial estimates and requirements(2), hu-
man rights and process issues(3), professional ethics(4) and ethical foun-
dations(5). The goal here is not to review this literature but to suggest that
it is an area of inquiry with which research ethics committee members
must familiarize themselves.
The reason for such a claim is this: Even if there were a national law, say,
requiring of research that it reduce (or at least not increase) health dispari-
ties, for instance, then it should surely be within the purview of a research
ethics committee to assess whether a protocol might in fact increase or