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Vulnerable person investigation plan (VIP) to optimise inclusion in clinical trials
  1. Ilana C Raburn1,
  2. Eline M Bunnik2,
  3. Antonia J Cronin3
  1. 1Philosophy, King's College London, London, UK
  2. 2Medical Ethics, Philosophy and History of Medicine, Erasmus MC, Rotterdam, The Netherlands
  3. 3MRC Centre for Transplantation, Kings College London, London, UK
  1. Correspondence to Dr Ilana C Raburn, Philosophy, King's College London, London, WC2B 4BG, UK; ilana.raburn{at}kcl.ac.uk

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Smajdor addresses the problem of inferior clinical outcomes among adults with impairments of capacity to give informed consent (AWIC). She notes that AWIC are generally excluded from clinical trials to protect them against harms and avoid exploitation and claims there is a causal link between involvement in clinical trials and favourable outcomes. She argues, given this link, that we should increase AWIC representation in clinical trials and can justifiably do so by recognising the capacity of AWIC to assent.

AWIC form a diverse group, with multiple aetiologies, including, for example, Down syndrome, traumatic brain injury and dementia. In some cases, the inability to consent may fluctuate so that the same person could be AWIC only at certain times. Yet despite these differences, the group has a shared unmet need. We agree with Smajdor that AWIC outcomes should be improved, but question whether simply increasing representation in clinical trials is sufficient to achieve this. We identify the following points:

1. AWIC are under-represented in clinical trials.

There is evidence of widespread exclusion of AWIC in clinical trials within the UK and abroad and it is often a specific exclusion criterion.1

2. AWIC have worse clinical outcomes and a lower life expectancy.

The life expectancy …

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Footnotes

  • Twitter @IlanaRaburn

  • Contributors ICR: first author, performed literature review and writing of the manuscript EMB: participated in defining the research area and manuscript direction and editing of manuscript. AJC: last author, supervision of research, participated in defining the research area and manuscript direction and writing and editing the 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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