According to the capacity-based model, only the objection of a decision-making-capacitated child is meaningful and has a moral value. Therefore, in this model, when a child is considered unable to give meaningful objection, the child’s opposition does not have strong moral significance and does not have to be taken into serious consideration by the researchers or parents. It is our view that the regulatory requirement to respect a child’s objection to research should be interpreted as also encompassing the distress-based objection.
We argue that children’s participation in research that has no potential to produce results of direct benefit to their health is a supererogatory act. If the act is supererogatory, then the refusal to participate in it does not need to be rational, informed and justified.
The current paradigm of research ethics and law is founded on the assumption of the supererogatory nature of research. Commentators agree that participation in biomedical research is a moral good. However, this is only one good among many. This moral good provides a reason to participate in research. Since one does not have a duty to do all possible moral good, one also is not obliged to choose this particular one, participation in research (Brassington 2011). The moral duty to participate in biomedical research can appear only in some rare, emergency situations (Shapshay and Pimple 2007). Therefore, the following analysis rejects the obligation model in research ethics and refers to the notion of supererogation. The obligation model is alien to the dominant regulatory framework in research that stresses the voluntariness of the subject’s decision to participate in a study and his/her right to withdraw consent at any stage, without any justification.
Accepting David Heyd’s model of supererogation, we state that participation in non-beneficial research might be described as a supererogatory act. The burden of proof that it is otherwise remains on the opponents of this view—they have to give an argument showing that a given act is a moral obligation. However, it seems that to date, all arguments supporting the obligatory nature of participation in research remain unconvincing (Brassington 2011, 2013; Shapshay and Pimple 2007; Lyons 2011; Rennie 2011). An act is supererogatory, according to Heyds, when “(1) It is neither obligatory nor forbidden. (2) Its omission is not wrong, and does not deserve sanction or criticism—either formal or informal. (3) It is morally good, both by virtue of its (intended) consequences and by virtue of its intrinsic value (being beyond duty). (4) It is done voluntarily for the sake of someone else’s good, and is thus meritorious”(Heyd 2012).
Participation in non-beneficial research seems to meet all these criteria. For instance, donation of blood samples or nasal swabs for research by healthy volunteers is not forbidden, but also not obligatory. Most members of the world human population will never participate in such a procedure; many decline participation when asked. The ethics and law regulating biomedical research support the view that this omission is not wrong, and does not deserve sanction. Any type of formal or informal criticism toward refusal to participate could be classified as an undue inducement. On the other hand, participation in this kind of minimal risk research, which potentially helps in developing new drugs or procedures (morally good intentions), is good in a moral sense. This is a meritorious act: it could be done voluntarily for the good of future patients.
The supererogatory nature of non-beneficial research provides justification for the voluntary character of participation in such research. Informed consent is a necessary condition of participation of a capacitated individual. However, while consent to participate in research must be informed, lack of consent or refusal does not have to be. Lack of consent can be based only on non-informed distress. If a researcher invites a 31-year-old competent woman to take part in non-beneficial research based on a blood sample or nasal swab donation, she can refuse before being informed about the nature of the research. No one can force her to become familiar with the information sheet or to discuss the research proposal with an investigator. Her ignorant refusal to participate in this supererogatory procedure must be accepted because she has no obligation to participate in this research, and no obligation to listen and talk to the researcher. She is also not obliged to base her own refusal on knowledge about this research. Since the current approach to research ethics accepts ignorant refusals of adults, we do not find any arguments for not accepting ignorant, even only distressed-based refusals of incompetent minors. In both cases, the subjects’ objections are just an expression of their preferences. Both groups know almost nothing about the proposed research, but they decline to participate, and their decisions should be respected.
Furthermore, participation in the decision-making process of significant events in a child’s life has an important role in the child’s development (Giesbertz et al. 2014a, b; Sibley et al. 2012). Giving the child an opportunity to object to participation or continuation in research may be considered a lesson in making an autonomous choice. Engaging even incapacitated children can have an immense impact on their developing autonomy and can strengthen their abilities to make responsible choices and behave autonomously in the health context (Alderson et al. 2006).
Both medicine and research are a joint venture; thus cooperation with a young patient and research subject is a necessary condition. Giving information and making a real agreement that objection would be respected is not only beneficial from a psychological point of view, but also helps to preserve trust in healthcare professionals, physicians, and parents (Spriggs 2010). In a healthcare setting, cooperation even with a very young child is possible. Therefore, the respect for distressed-based objections is one of the elements building a relationship between the researcher, child and parents that is professional and founded on trust. The quality of these relations may have a strong impact on the child’s willingness to cooperate with the physician and participate in future research.