Voluntary Informed Consent Is Not Risk Dependent

Morain and colleagues (Morain et al. 2019) rightly argue that several features of contemporary research demand a reassessment of dual-role consent. We have argued elsewhere, in line with the authors, that ethical reasons support the idea that the treating physician may be allowed under conditions to obtain informed consent for his or her own research (Dekking et al. 2014, 2016a; van der Graaf et al. 2018). In line with the authors, we have also argued that in contexts where care and research have become inextricably intertwined, such as in pediatric oncology, an escape from dual-role consent is virtually impossible. However, we disagree with Morain and colleagues that in situations where the risks, burdens, and benefits of research participation approximate those of clinical care, special concern about voluntariness in the research context is not warranted. In this commentary we set out that voluntariness can be compromised regardless of the risk–benefit profile of the research intervention. Moreover, whether dual-role consent is morally permissible cannot be determined solely by referring to the risks and benefits of clinical care. We take pediatric oncology as an example.

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