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Assent: going beyond acknowledgement for fair inclusion
  1. Alice Cavolo,
  2. Chris Gastmans
  1. Department of Public Health and Primary Care, Centre for Biomedical Ethics and Law, KU Leuven, Leuven, Belgium
  1. Correspondence to Alice Cavolo, Centre for Biomedical Ethics and Law, KU Leuven, Leuven 3000, Belgium; alice.cavolo{at}

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In her article Reification and assent in research involving those who lack capacity, Anna Smajdor shows how excluding adults with impairments of capacity (AWICs) to protect them from the risks of medical research has the paradoxical effect of harming them by reifying them.1 While the medical risks of excluding vulnerable populations in general from medical research are well known, the main risk being the creation of therapeutic orphans, the risk of reifying these populations is less discussed. Hence, we commend Smajdor for introducing an essential nuance in the debate on inclusion of AWICs in medical research. We also agree with her on the importance of acquiring assent from those who cannot legally consent rather than automatically excluding them from research, as we already do in paediatric research. However, we believe that she fails to acknowledge some practical challenges already observed in paediatric research that hinder the retrieval of assent from AWICs and, consequently, their inclusion in medical research. In this commentary, we will first introduce the main challenge to using assent to include AWICs in research, that is, the fact that individuals might oscillate within the capacity spectrum. We will then provide other examples of practical obstacles to the inclusion of AWICs …

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  • Contributors AC contributed to the design, wrote the first draft and revised the final manuscript. CG contributed to the design, provided feedback and revised the final manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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