Página 64 - Dimensiones éticas de las regulaciones en salud

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principles, providing a framework for the assessment of clinical research.
In a subsequent paper Emmanuel et al. extended the benchmarks to in-
clude respect for communities as they recognized that research conducted
in developing world contexts entailed a slightly differential set of consid-
erations(1). Nonetheless, the requirements represent a comprehensive and
generally agreed upon set of concerns that must be adhered to and evalu-
ated in the conduct of research.
In Canada, Canadian researchers are bound to the Tri-Council Policy
Statement. In this case, the Tri-Council refers to the three major re-
search funding bodies in Canada – the Canadian Institutes of Health Re-
search (CIHR), the National Science and Engineering Research Council
(NSERC), and the Social Sciences and Humanities Research Council
(SSHRC). All institutions and individuals receiving funding from these
sources are expected to be adherent to the Tri-Council Policy Statement.
This statement was first articulated and approved in 1998. However, as
we speak, there has been an extensive community engagement to update
and revise the Tri-Council Policy Statement. In fact, the oversight body
for maintaining the Tri-Council Policy Statement engaged in an extensive
exercise starting in the beginning of 2009, welcoming comments and in-
put into the revision. This process will end on the 30 June 2009.
In the Canadian context, guidelines are viewed as broad principles within
which research ethics boards would deliberate upon the ethicality of re-
search. It was expected then that the Tri-Council Policy Statement would
be a living document and reflect an evolving field of scholarship.
Ethics review: problems of calibration
Despite the well established role of ethics review mechanisms, be they
research ethics boards or institutional review boards, it has been increas-
ingly recognized that there are problems with the current way in which
ethics oversight operates. What I call the problem of calibration refers to
the increasing amount of oversight and bureaucratic processes required