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 …. (shrink)

In February 2022, the Court of Protection was faced with the question of whether a kidney transplant was in the best interests of William Verden. The case highlighted the legal, ethical and clinical complexities of treating potential kidney transplant patients with impaired decision-making. Above all, it exposed the potential risk of discrimination on the basis of disability when treatment decisions in relation to potential kidney recipients with impaired capacity are being made. In this paper, we draw on the Verden case (...) to (1) examine the role of the Court of Protection in cases relating to patients with impaired decision-making capacity who require a transplant, (2) to highlight the lack of empirical data on patients who have faced inequitable access to transplant and (3) highlight the shortcomings of the existing legal and regulatory framework in England and Wales guiding clinical decision making for patients in William’s position. We consequently argue that there is a clear need for action to ensure equitable access to transplant for those in William’s position. Furthermore, we suggest that there is a responsibility incumbent on policy makers and clinicians alike to develop a meaningful, and meaningfully operational, framework centred on preventing discrimination against potential organ recipients based on their decision-making capacity. (shrink)

Progress in transplantation outcomes depends on continuing research into both donor and recipient factors that may enhance graft and patient survival. A system of licencing for transplantation research, introduced by the Human Tissue Act 2004, which separates it from the transplantation process (then exempt from licencing), has damaged this vital activity by a combination of inflexible interpretation of the 2004 Act and fear of criminal liability on the part of researchers. Now, following the European Union (EU) Directive (2010) on standards (...) of quality and safety of human organs intended for transplantation, new UK Regulations have been drafted, which are intended to implement it. These Regulations impose a compulsory licencing system, similar to that for research, on the whole transplantation process. This goes beyond what is required by the Directive and may even have an inhibitory effect similar to that already seen in research. Initial draft Regulations went further, imposing criminal sanctions for breaches. However, following a public consultation process, the Department of Health (DH) has recently stated that, as a result of the overwhelming view of respondents that the proposed licencing system was unnecessary, all sanctions under the final Regulations are now decriminalised, with the sole exception of operating without a licence. While this does not eliminate the negative effect of licencing, it does suggest an awareness of the DH that excessive regulation unnecessarily harms the transplantation process. An opportunity thus arises for the Human Tissue Authority (the regulatory body for both the new licences and research licences under the 2004 Act) to end the current illogical and harmful separation of transplantation and transplantation research by ensuring that all centres licenced for organ donation, retrieval and transplantation are also fully licenced for related research. (shrink)