Even the most plausible readings of the uniform and relative interpretation generate problems for the identification of a justified referent for minimal risk. (1) The uniform and relative interpretations misconstrue the most fundamental difference between
6Other arguments that endorse the relative interpretation without endorsing the inclusion
of children in dangerous environments in higher risk research include Freeman, 1994, p.1-5; Noel & Birnie, 2010, p.18-22; Snyder, Gray, & Miller, 2011, p.5-13.
proposals for who should be the referent for minimal risk and (2) the uniform
interpretation does not identify a clear and consistent group of children as the referent for minimal risk; it follows that it does not identify a justifiable referent for minimal risk.
The main difference concerning the identification of a referent for minimal risk is not about uniformity and relativity. Some commentators who endorse a uniform
interpretation think that unequal treatment between children in research is, at times, legitimate and necessary. For example, Wendler points out that the fact that the degree of risk children face daily varies according to age suggests that researchers and IRBs should implement two different minimal risk thresholds, one for research with younger children and a second for research with older children (Wendler, 2009). Kopelman also explains this point well: she argues that justice does not require equal treatment for all children in research, it requires that “similarly situated individuals be treated similarly, different situated people differently, and that the differences and similarities are relevant” (Kopelman, 2004c, p.752). Thus, the disagreement does not seem to be over whether there should be any differences in the ways that different children are treated in research but instead about which kinds of differences justify a departure from equal treatment between children in research.
The main question concerning the identification of a referent for minimal risk is: which property should justify unequal treatment between children in research? Only the relative interpretation permits determinations about what should count as minimal risk to change based on a child’s health status.7
The uniform interpretation, on the other hand, does not permit a child’s health to play a role in determining what kinds of risks count as minimal for her. To put it another way, the main difference seems to be that only one interpretation understands health as being a morally relevant property that justifies unequal treatment between children in research. This difference is important; it addresses a fundamental question about what is just in research with children, that is, can it be permissible to expose sick children to higher degrees of non-therapeutic research risks than would be permissible with healthy children? But this point is not well captured by the distinction between uniformity and relativity. Describing the debate over minimal risk
7As mentioned above, all commentators agree, and for good reasons, that unequal
as a disagreement about whether a uniform or relative interpretation is appropriate
suggests that the morally relevant question concerning research with children is whether a uniform or relative standard is morally permissible. But this obscures the idea that one might be able to consistently endorse a uniform interpretation and allow for some justified departures from equal treatment.
Describing the two competing interpretations as uniform or relative suggests that each interpretation involves either a distinctly uniform determination or a distinctly relative determination. But each interpretation seems to involve both a relativistic and a uniform judgment. The uniform interpretation of minimal risk—like the relative
interpretation—requires a kind of relativistic judgment. Above, I explained that the main insight motivating a uniform interpretation is that some degree of risk should not be assessed as minimal risk for some children but not for others. That is, no matter what kinds of differences children face in their respective daily lives, minimal risk must be measured according to one fixed level of risk, faced by some particular group of children. For example, the group “healthy adolescents in Canada” may be chosen as the referent for minimal risk. In this case, minimal risk would be defined as the risks healthy
Canadian adolescents face in daily life and this degree of risk would be applied uniformly to children worldwide as the risk threshold for research involving children that does not aim to offer direct benefit. But to choose one group of children (e.g. healthy Canadian adolescents) as the morally relevant group is to make a relativistic determination. That is, if a relativistic determination is understood as a judgment that permits differential
treatment between children in research, then it seems that any attempt to choose a particular group of children as the referent is relativistic. It identifies one group of
children’s daily lives as morally relevant and requires non-therapeutic research risks to be assessed relative to this group of children’s daily experiences. To put it another way, the relative judgment is that the risks of a study’s non-therapeutic procedures may be measured against the daily experiences of some—but not all—children. It follows that a uniform interpretation does not seem to exclude all relativistic judgments.
Another example further illustrates this point. One might endorse an interpretation in which the referent for minimal risk is an average child. This interpretation is uniform; it measures minimal risk according to the daily experiences of average children. But it
also permits differences between what counts as minimal risk for different children. Average infants have different daily experiences than average 8 year olds. As a result, what counts as minimal risk for an average infant will differ from what counts as a minimal risk for the older child. There is a difference in the way we understand minimal risk for children of different ages, but it is a justified difference within a uniform
standard.
Further, a relative interpretation does not preclude a uniform one. On a relative interpretation of minimal risk, the degree of risk that can be considered minimal varies according to the levels of risk experienced in the daily lives of different children. But a variable standard does not preclude a uniform determination. Relativity and uniformity are not mutually exclusive concepts. For example, the phenomenon of sunset can be understood as both relative and uniform. The timing of sunset may vary according to an observer’s position on the earth. But the timing of sunset can also be understood as uniform; the sun sets when the sun disappears below the western horizon. Thus, sunset can be understood as having both properties. Similarly, the relative interpretation can be understood as involving a uniform determination. It involves a consistent, non-fluctuating standard: the minimal risk standard. Minimal risk is the unchanging rule that limits the degree of permissible risk. That is, a relative interpretation of minimal risk could be understood as involving a uniform application of the minimal risk standard (in addition to a variable determination about the degrees of risk that should count as minimal).
There is an important difference in the way each of these interpretations treats children in research. But the distinction between uniformity and relativity does not capture the morally relevant difference between these competitors. Describing the debate over minimal risk as a disagreement between a uniform and relative interpretation suggests that the morally relevant difference between the two is a difference about which standard (i.e. uniform or relative) is morally appropriate. But both interpretations involve relativistic and uniform aspects. Thus, this description impedes progress on the debate over minimal risk by obscuring the main point of contention between the competing interpretations. What seems to be important is not whether or not a relativistic or uniform judgment is made (it is made in both cases) but instead, whether or not the meaning of minimal risk should be permitted to vary on the basis of a child’s health status. Focusing
on uniform and relative standards obscures the central point of disagreement, which is about whether health is the morally relevant property justifying differential treatment between children in research. Thus, focusing on the uniform and relative interpretations obscure the fundamental difference between proposals for who should be the referent for minimal risk.
(2) The first objection identifies a problem with the distinction drawn between the two competing interpretations of minimal risk. A second objection concerns the uniform interpretation specifically. The uniform interpretation fails to identify one clear and consistent group of children as the referent for minimal risk. In the traditional formulation of the debate, commentators identify the uniform and relative interpretation as the two central competing interpretations of minimal risk. They then ask: “which kind of standard is morally appropriate?” These discussions aim to determine which, if either, of the two interpretations is consistent with the moral requirements of justice in research with children. This is an important question. However, it is different from the central question generated by the minimal risk standard. Minimal risk is defined according to daily life, but it is not clear whose daily life is morally relevant. Accordingly, we must determine “who should be the referent for minimal risk?”
The uniform interpretation does not focus uniquely on identifying the referent for minimal risk; it is also unclear about which group of children should be the referent. The uniform interpretation is attributed to a variety of commentators (Kopelman, 2004b; Fisher, Kornetsky, & Prentice, 2007; Wendler, 2010; Davidson & O’Brien, 2009; Diekima, 2006; Flotte et al., 2006; Glantz, 1998; Tauer, 2002) as well as committees commissioned to explore the ethics of research with children (National Commission, 1977; IOM, 2004; NBAC, 2001; NHRPAC, 2001). However, a close examination of the language in these documents reveals that there is less consensus than is often recognized. The position called the uniform interpretation can be divided into four positions that identify unique groups as the referent for minimal risk. These descriptions give rise to different and, at times, conflicting standards for minimal risk. Thus, proponents of the uniform interpretation do not all seem to support the same interpretation of minimal risk.
What is, at times, taken to be one position (the uniform interpretation), is more accurately described as four positions. The first identifies the referent for minimal risk as
“healthy children” (National Commission, 1977). The second identifies the referent for minimal risk as “normal, healthy, average children” (IOM, 2004; NHRPAC, 2001; AAP, 2003). The third identifies the referent for minimal risk as “normal, average, healthy children living in a stable society” (SACHRP, 2005) and the fourth identifies the referent for minimal risk as “the general population” (NBAC, 2001).