To the Editor: Dr Woodward's1
article draws incorrect conclusions from 2 reports2- 3
published by the National Bioethics Advisory Commission (NBAC).
We are puzzled by Woodward's comment that "NBAC has recently taken steps
both to strengthen and to weaken the consent requirement," referring to the
report on decision-making capacity2 as an
instance of the former and the report on human biological materials3 as an example of the latter. When advising the
president, NBAC does not presume that its role is always to recommend stricter
(or looser) protections. It is not, as Woodward claims, a "noteworthy departure"
for NBAC to have resolved as a matter of principle that "no person should
be enrolled in research without the twin protections of informed consent and
independent review of the research," nor to have recommended that federal
regulations be changed to allow IRBs to grant waivers of the consent process
even if it is practicable to obtain consent. Like any comprehensive ethical
analysis, NBAC's reports begin with no such presumptions; rather, we identify
the relevant issues, the context in which the issues occur, and the relevance
of particular ethical considerations and principles. Indeed, we consider it
a virtue of this commission that the deliberations on these 2 very different
topics—the involvement of persons with specific mental disorders and
the use (rather than involvement) of tissue specimens remaining from medical
and surgical procedures—could lead to different conclusions and recommendations
regarding the adequacy of existing federal protections.