Vulnerable person investigation plan (VIP) to optimise inclusion in clinical trials

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...
Source: Journal of Medical Ethics - Category: Medical Ethics Authors: Tags: Commentary Source Type: research