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Body matters: rethinking the ethical acceptability of non-beneficial clinical research with children

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An Erratum to this article was published on 20 December 2014

Abstract

The involvement of children in non-beneficial clinical research is extremely important for improving pediatric care, but its ethical acceptability is still disputed. Therefore, various pro-research justifications have been proposed throughout the years. The present essay aims at contributing to the on-going discussion surrounding children’s participation in non-beneficial clinical research. Building on Wendler’s ‘contribution to a valuable project’ justification, but going beyond a risk/benefit analysis, it articulates a pro-research argument which appeals to a phenomenological view on the body and vulnerability. It is claimed that children’s bodies are not mere physical objects, but body-subjects due to which children, as persons, can contribute to research that may hold no direct clinical benefit to them even before they can give informed consent.

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Notes

  1. This principle is described as the secure child standard and clearly distinguished from the best interest standard which they think is incompatible with non-beneficial research.

  2. To a certain extent Ramsey’s position is more complex: he thinks that pediatric research for the benefit of others is unethical, but allowable if investigators “err bravely” (1976, p. 21). He believes that if researchers are critically aware of the fact that what they are doing is wrong then research will go on, but in a cautious way (Wendler 2010, p. 281).

  3. The aids epidemic presented the pharmaceutical industry with the opportunity to loosen regulations regarding drug evaluation as aids activists sought immediate approval of potential life-saving experimental drugs (Sharav 2003, p. 15).

  4. Although, it is widely held that children should not participate in research that poses greater than a minor increase over minimal risk and does not offer the prospect of direct benefit, U.S. regulations include a category for pediatric research (407/50.54 category) that does not include an explicit limit on risks, raising the question of whether current regulations provide sufficient protection for pediatric research subjects. Since this type of research is only permitted in extremely rare circumstance, we will not discuss it any further here. For a recent critical reflection see Wendler (2013, pp. 1–8).

  5. They develop this interesting critique in regard to the moral development argument, but in our opinion it can also be applied to Wendler’s analysis.

  6. That is not to deny that social research can be ethically problematic (e.g. research on domestic violence, neglect, abuse, pediatric disorders, etc.). The point is rather that children’s participation in social research is not ipso facto problematic. In fact, a great deal of social research (such as on nutrition, life style, school etc.) is often considered quite mainstream.

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Authors and Affiliations

  1. Institute for Biomedical Ethics, University of Basel, Bernoullistr 28, 4056, Basel, Switzerland

    Eva De Clercq, Domnita Oana Badarau, Katharina M. Ruhe & Tenzin Wangmo

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  1. Eva De Clercq
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Correspondence to Eva De Clercq.

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De Clercq, E., Badarau, D.O., Ruhe, K.M. et al. Body matters: rethinking the ethical acceptability of non-beneficial clinical research with children. Med Health Care and Philos 18, 421–431 (2015). https://doi.org/10.1007/s11019-014-9616-3

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