Página 65 - Dimensiones éticas de las regulaciones en salud

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for institutional review board/research ethics board function relative to
the evidence of its value in enhancing the research process or protecting
human subjects. In recent years this has become a subject of research in its
own right. Examples of this are studies that document international and
local variation in ethics committee requirements. For example, Goodyear-
Smith and colleagues, studied research ethics approval for a multi-centre
study conducted in five countries (New Zealand, United Kingdom, Is-
rael, Canada, and the United States)(2) . They found that ethics require-
ments from ethics oversight committees ranged from zero to considerable
amendments designed to minimize participant harm in New Zealand.
They contend that assessment of minimal risk is a complex and difficult
function. They argue that ethics oversight processes currently in place ac-
tually create impediments to researchers doing their work.
Similarly Maskell and colleagues examined investigators experience in
obtaining local ethical approval for participation in a multi-centre study
in the U.K.(3). In trying to set up a multi-centre study of intrapleural
streptokinaise they determined that the local investigators spent 62 hours
photocopying to produce the 25,296 pieces of paper need to satisfy 51
local research ethics committees. As well, they found considerable varia-
tion in the time it took for approval and the number of meetings required
to get the research approved. They found that 33% of investigators felt
deterred from participating in future trials given the amount of work it
took to achieve approval.
Christopher Martyn in an accompanying editorial argued that there are
problems with current research ethics standards and the future of the
“ethical bureaucracy” requires prompt attention. This has led to studies
that document the concern that researchers are finding ways to sidestep
or avoid the process of ethics review entirely(4). Jim Giles, in a report in
Nature, documented that human subjects studies are going ahead without
official approval, commenting on a survey which indicated that research-
ers were increasingly frustrated with the delays involved in institutional
review boards and many researchers commenced data collection in the