Página 222 - Dimensiones éticas de las regulaciones en salud

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Health priorities, conflict of interest and
vulnerable populations: how ethics precedes
law in the protection of human subjects1
Kenneth W. Goodman
Introduction
Good-faith efforts to protect human subjects have, perhaps unavoidably,
led to a “culture of compliance” that sometimes promotes regulatory algo-
rithms instead of ethics. Originally a phenomenon in North America and
Europe, there are reasons to believe this regulatory response to legitimate
concerns is spreading to Latin America, Africa and elsewhere – where its
effects might have the unhappy effect of impeding the research needed
for improved health of the populations the regulations are intended to
protect.
Make no mistake: robust and comprehensive human subject protection
laws and policies are essential to high-quality research. Investigators in
both resource-rich and resource-poor countries must ensure that people
enjoy adequate protection when they consent to research and when, with-
out explicit consent, their information is used for public health.
1 Preparation of this chapter was supported in part by a grant from theU.S. National Institutes
of Health’s Fogarty International Center (grants R25TW008186 and 5R25TW006056 –
06, for the Pan American Bioethics Initiative); Bioethics Program PAHO; a Meetings,
Planning and Dissemination Grant from the Canadian Institutes of Health Research to the
Joint Bioethics Centre at the University of Toronto; and the Jay Weiss Center for Social
Medicine and Health Equity at the University of Miami Miller School of Medicine.