The PP states that the interests of the individual research subject should prevail over the interests of science and society. How should this imperative be understood? Joel Feinberg, albeit in entirely different context, suggested three ways in which this sentence may be interpreted (Feinberg 1984, 39). In the first, the subject’s interests prevail if and only if all interests of the subject are promoted by her participation in research, either equally or unequally. According to the second interpretation, in order to be consistent with the PP, it suffices for a research project to promote one or a set of particular interests of the subject, without endangering or impairing any of her other interests. Under the third interpretation, the research respects the PP when it promotes some of the participant’s interests while threatening others, “but the ones promoted are superior in some relevant way to those that are impaired, so the result is a net gain for … [the subject] on the whole” (Feinberg 1984, 39).
The first and the second way of interpretation seems difficult to apply in the context of research. As already explained, every research project exposes participants to risks which are inherent to tested drugs, devices, or procedures. It also involves risks associated with standard medical interventions (e.g. injections, biopsies, or ultrasound) performed for scientific reasons only in order to—among others—better identify, measure, or document the study results. Thus, some of the subject’s interests are always put in danger for the sake of developing socially valuable, scientific knowledge.
The third interpretation of the PP, inspired by Feinberg, seems more promising, as it accepts trade-offs between the subject’s interests. This understanding fits well into the standard justification for allowing competent individuals to enter non-beneficial studies, since those individuals are regarded as exclusively entitled to makes trade-offs between their own different interests as well as between their interests and the interests of science and society. If a competent person gives valid informed consent for participation in non-beneficial research, it is assumed that, in her best judgment, the participation is in her interest—it en bloc promotes her interests. Thus, the standard requirement to obtain informed consent from competent subjects makes such research compliant with the PP.
The third interpretation of the PP has been implicitly adopted by those numerous ethicists who try to justify the involvement of children in non-beneficial studies by arguing that while participation in this type of research puts some of the child’s interests at risk without any compensating clinical benefits, it furthers other important non-clinical interests of the subject. At least two different versions of this argument have been advocated in the literature. The first concentrates on potential benefits for children’s interests in moral and/or intellectual growth (developmental benefits argument); the second version assumes that contribution to a valuable non-beneficial paediatric study is en bloc beneficial to children as it makes their lives overall better. In what follows, I discuss each of these non-clinical benefit arguments in the context of the PP.
Risky for Health Interests but Developmentally Beneficial
The developmental benefits argument as described above assumes that the participation in non-beneficial research may promote the minor-subject’s interests, taken as a whole, since participation can contribute to the child’s interests by developing certain moral and/or intellectual capacities and these potential developmental benefits may outweigh the risks to the child’s health interests associated with the non-beneficial research.
The developmental benefits argument has been used by several authors in various guises (Bartholome 1976, 1977; Ackerman 1980; Gaylin 1982; Redmon 1986; Williams 2012). All proponents of this argument share the general conviction that participation in non-beneficial research has the potential to teach children lessons regarding the importance of helping others or altruism.Footnote 1 They, however, differ in their individual descriptions of the expected developmental benefits. For instance, Bartholome argues that participation in research may help children to “become sensitive to moral obligations and develop a disposition towards choosing that which is good” as it gives them an opportunity for actually experiencing situations in which that sensitivity is required and this disposition promoted (Bartholome 1976, 44). Ackerman agrees and adds that a child’s involvement in research may help “inculcating interests and dispositions of character in him which will allow him to become a morally good, well-adjusted and self-fulfilled adult—a ‘right kind of person’” (Ackerman 1979, qtd in Binik 2018, 3), i.e., a person having “acknowledgment of the publicly recognized moral code” (Ackerman 1980, 101). Redmon extends this argument to other benefits, such as a sense of pride in contribution to a valuable scientific project and to better understanding of how scientific research practice works (1986). For Williams, central is the potential of non-beneficial research to teach children lessons on the value and conditions of successful collaboration (2012).
Importantly, all proponents of the developmental benefits argument agree in principle that the potential developmental benefits can override risks stemming from the participation in non-beneficial research. Thus, they assume that these particular benefits may be—in a morally relevant sense—superior to potential research-related harms. Redmon explicitly stresses this fact by claiming that developmental benefits have a different nature from the majority of others good, such as money, health, or prestige. “To aid in the development of intellectual and, especially, moral abilities (or sensitivities) is to aid in the development of the individual’s autonomy” (Redmon 1986, 81). Moreover, all advocates of the argument assume that potential developmental benefits may offset only very low risks for their health interests. Thus, only such trade-offs between the minor subject’s interests are—in their view—morally acceptable.
At first glance, the developmental benefits argument seems to provide a plausible solution for the conflict between the PP and non-beneficial studies involving children. However, as shown below, the argument is vulnerable to several serious objections which make it of (at least) limited use.
The first and the most significant problem with the argument regards its scope. Both its advocates and critics note that the assumed developmental benefits may accrue only to children who already possess a certain level of cognitive capacities necessary to understand and appreciate the expected moral and/or intellectual lessons stemming from the participation in non-beneficial research (Bartholome 1976, 1977; Ackerman 1980; Redmon 1986; Williams 2012, Wendler 2010, 2012, Broström and Johansson 2014; Binik 2018). Obviously, enrolment in such research will not contribute to the moral or personal development of infants and young children who are unable to understand the concept and value of benevolence or altruism or have no capacity to comprehend scientific goals and the collaborative nature of research practice. This means that participation in non-beneficial research does not offer those children developmental benefits which could overweigh research-related risks. Ergo, it cannot result in a net gain for their interests. Consequently, non-beneficial studies on younger children do not meet the requirements of the PP and, therefore, should not be performed. This conclusion is, however, difficult to accept for both pragmatic and ethical reasons.
The second objection stems from the insufficient empirical evidence supporting the claim that non-beneficial research indeed has a potential to contribute to the moral and/or intellectual education of participating children (mature enough to learn the lesson). Some data suggest that children may derive some developmental benefits from participation in non-beneficial research. However, this data is very limited and does not allow for generalizable conclusions (Wendler et al. 2012; Luchtenberg et al. 2015; Staphorst and van de Vathorst 2015; Staphorst, Hunfeld, and van de Vathorst 2017). Additionally, as David Wendler has rightly noted, many non-beneficial studies are actually very ill suited for teaching children about altruism or the value of self-sacrifice for the benefit of others (2010, 94). This is because the risks and burdens experienced by subjects do not always contribute to the expected social benefits—some research bring insignificant or negative results; and even when they do generate positive results, subjects’ sacrifices and efforts do not directly and immediately translate into “visible” social benefits. It usually takes years for the social benefits of research to be realized and implemented. Moreover, it is almost certain that children’s abilities to appreciate the lesson involved in participation differ depending on their age, maturity, personality traits, individual history, clinical status, medical experience, and the quality of their relationships with significant others, especially parents. Thus, at present it seems reasonable to claim only that some non-beneficial research projects may offer developmental benefits to some minor subjects.
The third problem with the developmental benefits argument lies in the fact that neither proponents of the argument nor current research practice seem to actually pay attention to the realization of developmental benefits. As Linus Broström and Mats Johansson (2014) rightly point out, if children’s moral and/or intellectual development were indeed critical for the compliance with the PP, these developmental benefits should be among the reasons for children’s involvement in non-beneficial research, instead of being “a mere welcome byproduct” of their participation. Moreover, the expected benefits should be clearly articulated, promoted, and maximized and they should be realistic, not just likely to occur. In other words, a true concern for supporting children’s development through participation in non-beneficial research should have led to the creation of regulatory framework aimed at controlling factors likely to affect the realization of intended developmental goals. Clearly, depending on the exact nature of the expected benefit “some kind of research participation may be conducive to it, while other kinds will have little or no prospects of furthering the relevant development” (Broström and Johansson 2014, 57). For example, if the expected benefit is to make children more altruistic, it cannot be achieved without offering them extensive, understandable, and empathy-invoking information about the social value and scientific necessity of the research and without asking them for their assent for participating in the project. Whereas, when the goal is to develop in children an acceptance for the fact that interests of other are sometimes more important than their own, enrolling them into research without asking their assent might seem—at least in some cases—to serve better to fulfil this goal. Unfortunately, in reality neither proponents of the discussed argument, nor members of research community, including research ethics committees, nor public policymakers dealing with biomedical research are actually concerned by these issues. This fact adds strength to the conclusion that the mere fact that some non-beneficial studies may result in moral and/or intellectual growth of some children taking part in it, is not sufficient to make the practice of non-beneficial paediatric research consistent with the PP.
Risky for Health Interests But Leading to an Overall Better Life
David Wendler conceived the second strategy for reconciling the PP with the practice of non-beneficial research on children (2010, 2012). His approach builds upon the developmental benefits argument, but—in the author’s own opinion—it is superior to the latter as it does not exclude infant and very young children from non-beneficial studies. Wendler argues that participation in non-beneficial paediatric research can en bloc promote subjects’ interests, no matter their age, cognitive competences, or emotional sensitivity because it gives children an opportunity to physically contribute to a valuable project. The sole fact of making such a contribution is the source of non-clinical benefit for children, independently from their mental state or preference towards the participation. And “this is so, because having a life that includes more valuable achievements makes for a better life overall, and one of the things that is in our interests is to have a better life overall in this sense” (Wendler 2010, 133). Wendler argues further that contribution to a valuable research project can be beneficial for children in two more ways. Firstly, individuals, who contributed to valuable projects as children, may later embrace those contributions and regard them as important parts of their lives. “Moreover, the fact of having made those contributions may lead the individuals to go on to make other valuable contributions and thereby lead better lives than they would have otherwise” (Wendler 2012, 29). All these potential non-clinical benefits can outweigh some risks associated with research, though only very low ones. Consequently, the introduction of these novel benefits provides an explanation of how the conduct of paediatric non-beneficial studies can satisfy the PP.
In order to fully understand Wendler’s argument it is crucial to note that the argument is based on a specific account of human well-being (welfare, as he prefers to say) comprising of five categories of interests: (i) interests in satisficing one’s biological needs; (ii) interests in having certain experiences or states of mind while avoiding others; (iii) interests in having meaningful relationships with other persons, animals, the environment, activities, or with specific projects; (iv) interests in achieving one’s worthwhile goals (preferences, dreams, desires, plans or projects); and finally (v) interests in “human achievements, accomplishments and contributions that are valuable for us given the kinds of being we are” (Wendler 2010, 133). This last category of interests “make for a better life, all things considered” and it contains “certain things that qualify as valuable achievements” (Wendler 2010, 133), even when the individual, whose life it is, does not experience the realization of these achievements and even when these achievements do neither satisfy nor realize her personal preferences or goals. This category of objective human interests provides foundations for Wendler’s position, but—as this paper shows—it is also the main source of its weakness.
Wendler’s argument is often discussed in the literature (Singer 2011; Kopelman 2012; Spriggs 2012; Wachbroit 2012; Piasecki, Waligora, and Dranseika 2015; Binik 2018). Surprisingly enough, critics rarely focus on his assumptions regarding human nature and human interests. Instead, they stress that the argument is non-intuitive, empirically unsupported, or normatively uninteresting. For example, Ariella Binik (2018) claims that the idea that a physical, non-autonomous contribution to a valuable research makes a person’s life better, goes against commonly held moral intuitions regarding things which have any bearing on the value of human life for the individual whose life it is. This non-intuitiveness is even more evident—she adds—when the contribution to research with insignificant or negative results is considered (also Wachbroit 2012). Especially since Wendler himself stresses that the value of the contribution, for life of a person concerned, “can depend on their ultimate consequences” (2010, 193).
Loretta Kopelman (2012) challenges Wendler’s argument by pointing out unavoidable uncertainty over whether individuals will come to embrace a contribution made as children. She recognizes that Wendler allows the possibility that former participants of non-beneficial paediatric research may be ignorant, indifferent, or even regretful about their participation. Nevertheless, she rightly notes that the force of this part of his argument, which pertains to benefits coming from embracing valuable contributions done in the past, depends upon facts on how often former subjects indeed benefit it this way. The relevant data is, however, missing.
Merle Spriggs accurately notes that by limiting a priori his focus to socially valuable studies posing only low risk and involving children who cannot give consent but do not dissent either, Wendler’s argument “does not amount to anything of significance” (2012, 43).
Although these are all valid concerns, they do not touch upon the essential problem of Wendler’s position, which derives from the concept of interests in realizing “human achievements, accomplishments and contributions that are valuable for us given the kinds of being we are” (Wendler 2010, 133). This concept presupposes a substantive—though barely sketched—vision of human nature with its goods. Wendler does not deny it. He acknowledges that his account of human interests “follows from our nature” as determined by the long process of evolution; from “the kinds of being we are, the kind of mind we have” (Wendler 2010, 113). Certain things are in our interest, even when they do not affect our experiences or fulfil our preferences or even if we are unaware of their occurrence—he claims—“because of the way in which they fit into our lives, into lives that are human and good for us” (2010, 123). Wendler further suggests that affecting others and the world as whole in a positive way—i.e. “making a world a better place” (2010, 138)—is one of the human ends. On the most basic level, human beings are part of the physical world. They are influenced by the world and others and they have an influence on all things which surround them. The better they affect the world (autonomously or non-autonomously; actively or passively), the more valuable, human achievements occur in their lives, and the better their overall lives are.
These are the basic philosophical assumptions behind Wendler’s argument. I believe they cannot be accepted, at least, for the two following reasons.
Firstly, the account of human nature proposed by Wendler is far from being conceptually and normatively correct. There is nothing more controversial in philosophy than “the nature of our lives” (Wendler 2010, 136), even if it is considered as determined by the evolutionary history of our species. The mere fact that humans have certain biologically driven needs, capacities, or dispositions, does not have any significant implications for how humans ought to live and what is good for a person qua member of the species and qua an individual, whose life it is. Wendler claims that being narrow-minded, holding false beliefs (such as racism), “missing out on the richness of experience that can be gained from interactions with and understanding of a broad range of groups, cultures, ways of life, and individuals” (2010, 200), or causally contributing to a wrong cause or harming others does not fit to the nature of human life. Lives of such persons are overall worse than lives of those who are open-minded, educated, have many rich experiences, and who contribute to making the world a better place. But how do all these claims follow from our nature and our evolutionary history? Wendler seems to forget that human biology has no direct implications for normative goals of our lives. What makes human life valuable, in a morally significant sense of the word, is not set by evolution but rather by moral reflection (FitzPatrick 2021).
The second objection concerns the fifth category of human interests distinguished by Wendler—“human achievements, accomplishments and contributions that are valuable to us.” The realization of these interests—when entirely separated from individuals’ experiences, preferences, or goals—cannot be part of a plausible theory of human well-being or welfare, because the fulfilment of such “interests” does not affect an individual whose well-being is at stake. The contribution to a valuable project makes the life of a purely causal contributor (more) valuable, not because it makes the life of the contributor better for her, but because of making the lives of others, who have benefited from the project, better for them. Wendler admits that his fifth category of human interests “extends the present account beyond an account of human welfare strictly understood” (Wendler 2010, 136) and that it presupposes the existence of “an independent normative evaluation of our contributions and the impact they have on our overall lives that is independent of the contributor’s own normative evaluation of them” (Wendler 2010, 201). But why should we consider causal contributions, which neither affect the contributor nor have been embraced by the contributor, to constitute her well-being? Wendler tries to answer the latter question by arguing that the fifth category of interests is a part of our interests because we have an interest in our lives going better overall. “To have a valuable overall life is itself a significant human achievement and is realized by achieving specific human achievements that contribute to a better life overall” (Wendler 2010, 139). It is needless to say that his replay only adds on to the confusion. It raises the same question about how “an interest in our lives going better overall” can be constitutive of our well-being, when it falls into the fifth category of objectively valuable human achievements.
To summarize, Wendler’s claim that purely causal (physical) contribution to a valuable non-beneficial paediatric study makes life of a participating individual overall better for this individual, rests on shaky philosophical grounds and insufficient empirical evidence. Thus, it does not provide a valid explanation on how this category of research can be in line with the PP.