Página 62 - Dimensiones éticas de las regulaciones en salud

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Overcoming the problem of calibration:
towards a scholarly agenda for research ethics
Ross Upshur
Introduction
In this paper I will discuss problems in the current oversight and gover-
nance mechanisms of research on humans. In particular I will discuss the
existence of poor calibration between the world of scientists and the re-
search ethics oversight mechanisms put into place to protect human sub-
jects. I will describe how they fail to achieve what they seek to achieve, and
conclude with some thoughts for a scholarly agenda in the 21st century.
Historical context
The origins of research ethics are well known to people familiar with re-
search ethics. They commence from a consideration of the abuses to hu-
man subjects in World War II, specifically the hypothermia experiments
conducted by Japanese scientists on prisoners of war and the atrocities
perpetrated on individuals in concentration camps in Nazi Germany. The
concern for the need for processes to protect humans from exploitation
in research has been reinforced in the decades since WWII with notable
examples occurring with the Tuskegee Syphilis Study conducted in the
United States as a natural history study on men with syphilis despite the
existence of penicillin to cure them; the Jewish Chronic Disease Hospital
Study; the Willowbrick Study; and the San Antonio Contraceptive Study.
Many of these cases have been discussed and analyzed in classic papers and
form the basis of most curricula in research ethics. Concerns persist in the
modern era, as exemplified in the Gelsinger Gene Therapy case.