To the Editor: Dr Woodward1
notes that there are efforts under way to alter US federal regulations that
govern medical research, and she expresses concern that these changes may
be influenced by pressures that "subordinate the interests of the subject
to those of science and society." Her fears may be justified and should be
heeded. However, I take issue with her argument that the concept of "minimal
risk" is a prime victim in this scenario and that it is critical to the health
of the current system for protecting human subjects. I would like to propose
that it is, instead, one of the causes of the illness.
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