Component analysis provides resolutions to some of the problems complicating research with children. But it does not provide an adequate analysis of the concept of minimal risk, which is central to the justification of non-therapeutic procedures with children. That is, the concept of minimal risk is not adequately justified or explicated. The idea that the risks of non-therapeutic research procedures on vulnerable populations should be
constrained is persuasive. Children are vulnerable; they cannot protect their own interests and are dependent on adults for the satisfaction of their basic needs and wants.
Accordingly, they require more protections in research. While it may be permissible to expose them to some risk in the interest of others, restricting the permissible degree of risk helps to ensure that children’s interests will not be sacrificed for the benefit of others.
Further, it seems reasonably uncontroversial that the permissible degree of non- therapeutic risk to which they may be exposed should be low. Undertaking a high degree of risk purely in the interest of others requires an understanding of the nature of this risk and autonomous decision to take it on. Thus, restricting the risks of non-therapeutic procedures on children to a low degree helps to ensure that they will be respected as persons and not exploited for the sake of society. One way of operationalizing the ‘low’ or defensible degree of risk requirement is by measuring risks according to the concept of ‘minimal risk’. The concept of minimal risk offers a threshold according to which to assess the permissibility of non-therapeutic risks. That is, it provides a measure by which to determine the kinds of risks that are low enough to protect children’s interests in research. But what degree of risk is low enough to prevent exploitation? What should minimal risk mean? And how should we determine when it is surpassed?
Commentators endorsing a minimal risk threshold sometimes suggest that it is reasonable to measure non-therapeutic research risks according to the risks of daily life because these risks replace or are sufficiently similar to the risks a child would otherwise undergo in the pursuit of her normal risky daily life (Freedman, Fuks, & Weijer, 1993). But how can we know when the risks of research actually replace and do not add to the
risks a child would otherwise face? In addition, what makes the risks of daily life morally relevant or permissible? And how do we ensure that these risks are “sufficiently similar” to the risks of daily life? Further, if minimal risk should be defined according to the risks of daily life, then whose daily life should be used as the reference point? That is, who should be the referent for minimal risk? Without convincing answers to these questions, the minimal risk concept remains unclear. Moreover, without an adequate analysis of the concept of minimal risk, Ramsey’s challenge remains unanswered. That is, it is not clear whether, and if so under what conditions, children can justifiably be included in research. Thus, the next chapters aim to explicate and justify the concept of minimal risk.
In this chapter, I have argued that the justification for research with children depends on several important insights. First, it depends on an argument about social utility. Research with children is permissible, in part, because it is the source of a critical public health benefit: it improves medical practice on the basis of scientific evidence. Consequently, it is justifiable because of its ability to improve the medical care of
children. But this justification is insufficient. It does not provide a persuasive reason why it is permissible to expose particular children, who cannot consent for themselves, to research risks for the benefit of others. Second, commentators argue that at times, it may be permissible to expose children to risk purely for the sake of others. This argument successfully establishes that it might be permissible to expose children to harm, but it leaves other important questions unanswered. It does not explain why it is permissible to enroll children who cannot consent to a trial and it does not explain the degree of risk to which a child can be exposed in the interest of others.
Two additional arguments provide partial answers to these questions. One claims that the requirement to obtain informed consent applies only to people who can make autonomous choices. Given that children are not autonomous, respecting their moral worth in research is not subject to the requirement to obtain informed consent. Instead, parents or guardians can provide surrogate consent for children’s participation in research. This argument successfully establishes that children can participate in some research but it does not explain when a parent can, consistent with her parental duty to respect and protect her child, enroll that child in a clinical trial.
One promising way of establishing the conditions under which it is permissible to enroll a child in a trial is to derive insights from the conditions that legitimize the
inclusion of adults in research. Adults can enrol in research when an ethics review committee has determined that a research protocol is ethically permissible. Requiring independent review by an ethics committee helps to ensure that a group of experts finds a particular research protocol valuable and permissible, which helps to ensure that parents are given the option to consent on behalf of their children only when enrollment in the trial is a reasonable option. Further, the justification for research with children depends on ethics review committees making reasonable determinations about whether a trial is permissible. Component analysis is a useful mechanism that helps to guide ethics review committees in their harm benefit determinations. Component analysis provides a
convincing explanation of when it is permissible to expose children to therapeutic research procedures. But it does not provide a sufficient explanation of the conditions under which non-therapeutic procedures are permissible for children. It relies on—but does not adequately explicate and justify—the concept of minimal risk. It follows that a successful justification for research with children depends on a more persuasive
justification for minimal risk. As noted above, the remaining chapters of my thesis will analyze this concept.