Friedmann's good judgment comes through on all but one topic
covered by
this timely and important article. I take exception only to the following statement:
"The single most important mechanism for ensuring patient protection...is
accurate and full disclosure.. and a well-executed consent process."
Informed consent is a non-negotiable moral obligation in clinical
research,
but I do not agree that it is the "single-most important mechanism"
to protect patients. Historical experience shows two
other sources of protection that are more critical: (i) a vigilant
institutional review board's prior group review of risks, benefits, and the plan for the process
and content of seeking voluntary and informed consent, and (ii) clinical
investigators whose primary loyalty is to the larger social judgments that
ought to govern both medicine and clinical research. These are judgments
about respect for persons, maximizing the benefits and minimizing the
harms
of experiments, and being fair in the selection of patient-subjects.
Medicine and clinical research do not generate these judgments, it is the physicians
and investigators who work within the orbit or the society that give voice to
these judgments in morality and law. Wherever higher loyalty to these
norms
is compromised by conflicts of interest of a monetary or self-regarding
nature, research subjects and the integrity of biomedical research can and
do suffer.
My experience is that an adequate consent process and
understanding can almost always be achieved, but it can never equal the
degree of protection afforded by these other two sources. The order
of the degree of protections is 1) the integrity of the prior group
review
process, 2) the integrity of investigators, and 3) the adequacy of
voluntary informed consent.
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