DIFFICULTIES. Unfortunately, the risk–benefit solution leaves
key terms undefined or poorly defined, allowing different
interpretations concerning when risks of harm are warranted
and what constitutes a benefit (Freedman et al.; Kopelman,
2000, 2002; National Bioethics Advisory Commission
[NBAC]). For example, consider the pivotal concepts of a
“minimal risk” and a “minor increase over minimal risk.”
The federal rules state: “Minimal risk means that the probability
and magnitude of harm or discomfort anticipated in
the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance
of routine physical and psychological examinations or
tests” (“Protection of Human Subjects,” 1993, section 102i).
The first part of the definition focuses on everyday risks, and
the second on routine examinations. (Interestingly, the
National Bioethics Advisory Commision [2001] recommended
dropping the second part of the definition in favor
of the more permissive first part, whereas the Council for
International Organizations of Medical Science [CIOMS]
omits the first [Council for International Organizations of
Medical Science, 2002].)
Kopelman has argued that this definition is morally and
conceptually problematic, especially the part using “everyday
risk”: First, how should people establish thresholds for
the probability and magnitude of harm used to identify
everyday risks, and even if they solve this problem, why are
everyday risks morally relevant for determining acceptable
research risk? People’s daily casinos en ligne risks may include car accidents
and terriorist attacks. Is it possible to know the nature,
probability, and magnitude of these everyday hazards well
enough that they could serve as a baseline to estimate
morally acceptable research risks for children? It seems easier
to determine that a study asking children to stack blocks is a
morally acceptable, minimal-risk study than to estimate the
nature, probability, and magnitude of whatever risks of
harm people normally encounter.
Second, given the different hazards in different countries
and communities, what locale or locales should be used
to assess everyday risks in determining morally acceptable
research? Some favor a relative standard by which minimal
risk is judged against the background of the children’s
location, environment or condition. Others reject this “relativistic”
standard in favor of an absolute standard, saying
that all children should have the same standard; otherwise
one reaches morally abhorrent conclusions such as that more
risks can be taken with children in dangerous neighborhoods
than with children in safe and affluent neighborhoods.
Third, why should everyday risks of harm be regarded as
morally relevant for determining that research risks are
minimal when some everyday risks are great?
Fourth, if this is a useful and clear standard, why has
there been sustained disagreement over whether common
procedures should be viewed as having a minimal risk, a
minor increase over minimal risk, or greater risk? Since the
regulations appeared decades ago, there have been sustained
and substantive differences among pediatric experts in both
treatment and research settings about how to assess the risk
of procedures such as venipuncture, arterial puncture, and
gastric and intestinal intubation (Janofsky and Starfield).
Investigators and others concluded that better standards of
risk assessment in children’s research had to be formulated
(Janofsky and Starfield; Lascari; National Bioethics Advisory
Commission; Kopelman, 2002).
