[Speech]

. t

that parents assume that their child will benefit. This could pose a problem when children
face life threatening diseases.
If the research does not offer the prospect of direct benefit, it must be likely to yield
generalizable knowledge about the subject's disorder. This tends to limit research to issues
directly related to children. In addition to the usual requirement for parental permission
(which is based on the parent's own assessment of benefit and risk), the IRB must make its
own assessment based on the following features.
First, the "generalizable knowledge must be of vital importance to understanding
the child's disease." While "vital" is not defined, it suggests the IRB must make a judgment
regarding the scientific merit of a proposed study.
Second, "the intervention presents experiences to subjects that are reasonably
commensurate with those inherent in their actual or expected medical situation." This is an
attempt at insuring that permission and assent are truly informed.
Third, the intervention can only represent a minor increase over minimal risk. The
regulations don't specify what counts as a minor increase over minimal risk. Thus it is up
to the IRB to decide whether interventions, such as placebo injections, sedation, and
bronchoscopies are greater than a minor increase over minimal risk.
IRBs accept the challenge of interpreting the regulations. However, it has been.
twenty years since the Belmont Report and the problems with interpretation need more
attention. While NBAC may be a good place to start, a more permanent forum would be
useful to address the evolving conceptual challenges.
Procedural Issues. More important than the problems of conceptual vagueness,
there are a number of procedural issues facing IRBs that pose greater risks-to children, for
which an improved centralized mechanism of oversight of research and IRBs is necessary.
The premise of the IRB approach is that local regulation, and in essence, self
regulation, is adequate. While I believe that the IRB concept should be continued, there are
significant modifications that should be made to keep up with the research landscape of the
twenty first century:
1. A better mechanism for oversight and monitoring of multicenter trials is
needed.
2. There needs to be more organized local oversight of community investigators
practicing outside of academic institutions.
3. Research that falls outside of NI or FDA purview should still be reviewed
4. There needs to a be a singular mechanism for oversight of IRBs.

3