A ‘contextualized’ reply to Wendler’s new justification for pediatric research devoid of therapeutic benefits.

David Wendler, head of the Unit on Vulnerable Populations in the Department of Bioethics at the NIH Clinical Center, just published a target article on AJOB where he presents new arguments for pediatric clinical research that offers no therapeutic benefits to the participating children. Some of these arguments were also presented in a more extended form in his 2010 book published by Oxford University Press and titled ‘The Ethics of Pediatric Research’. Wendler argues that research on children devoid on therapeutic benefits can be justified—provided that the risks for the participants are low—on the basis of two considerations: (i) Participating in clinical research is contributing to a valuable project and (ii) contributing to a valuable project is in any child’s broadly conceived interests.
In an open peer commentary published on the same January 2012 issue of AJOB, Mameli and I argue that Wendler’s argument is unsatisfactory in that it fails to consider the context of clinical research. By ‘context’ we refer the conditions in which participants find themselves and, more specifically, the kind of access to health care that they have. As a case study and an application of our arguments, we chose to analyse the recent COMPAS-Synflorix trial which represents an instance of a trial in which subjects were participating in research in exchange for access to health care resources that would otherwise not be available to them. We argue that under such a unique ‘context’ the fact that participants “contribute to a valuable project” -as put by Wendler – by participating in clinical research cannot by itself provide a sufficient justification for the ethical permissibility of the trial, notwithstanding the low risks involved in participation.
To note that the COMPAS-Synflorix trial represents also an instance of so-called off-shoring of clinical research to low- and middle-income countries that has been steadily increasing in the last couple of decades. More details on the COMPAS-Synflorix study can be found on this older post on this same blog. In addition, more open peer commentaries in reply to Wendler’s arguments can be found here.