Página 71 - Dimensiones éticas de las regulaciones en salud

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Moving forward
I think it is time for a frank assessment of the principles and practice of
research ethics oversight. The dysfunctions have been amply documented
and have been referred to by Fost and Levine as the “dysregulation of
human subjects research(20).” Fost and Levine argue that the regulatory
system for protecting human subjects in research in the United States is
increasingly dysfunctional. There is increasing concern that the system is
over-regulated, that more time and expense are devoted to activities of
marginal utility in protecting human research participants. Indeed, there
is some concern that the activities of research ethics is actually reducing
protections for human subjects and diverting energy that could be spent
on more fruitful tasks and actually creating disincentives for individuals
to participate or submit their work to research ethics boards. This was
brought to the forefront by an editorial published in the New York Times
by Atul Gawande, a noted writer in The New Yorker(21) . There, he writes
about the actions of a research ethics review process thwarted the imple-
mentation of a potentially life saving checklist for quality improvement
and reduction of mortality.
I think it is important that moving forward that the era of defaulting ev-
ery issue of research oversight to research ethics board mechanisms stop.
Increasingly research ethics boards have become the dumping ground for
a heterogenous set of concerns, many not related to the protection of
human subjects. Increasingly, as Fost and Levine note, requirements are
becoming inflexible and interpretations of regulations have become quite
narrow. As well, systems and policies have led to a concern more with
institutional protection than human subject protection. Secondly they
note that the cost of the system increases without evidence of a return on
investment with regard to protection of patients or facilitating research
boards. Finally, they argue that the burdens of IRB review “discourage
young investigators.” This is actually an important dimension of revitaliz-
ing concern for research governance. There is a need to see that preparing