Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK

Trials
Victoria ShepherdKerenza Hood

Abstract

Around two million adults in the UK have significantly impaired decision-making capacity. However, there are concerns that this population is under-represented in research, due in part to the challenges around obtaining consent. Under-representation of populations denies those who would have wanted to participate the opportunity to make a contribution to society, but also fails to generate results that are applicable to them. Consequently, the evidence base for their care is poorer than for other populations. We recently published in this journal an analysis of Participant Information Sheets provided to consultees and legal representatives of adults who lack capacity and noted the small number of trials designed to include adults who lack capacity. In order to understand how many adults who lack capacity to consent are actually enrolled in clinical trials, we further explored how many of the participants lacked capacity, and who acted as a consultee or legal representative on their behalf. The ISRCTN registry was searched for UK clinical trials in conditions commonly associated with cognitive impairment that were designed to include (or not exclude) adults who lack capacity to consent. Details about participants and capacity st...Continue Reading

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Citations

Jan 30, 2021·BMC Medical Informatics and Decision Making·Victoria ShepherdKerenza Hood
Feb 10, 2021·Journal of the American Geriatrics Society·Julia A LoosenAmy J H Kind
Oct 17, 2021·Clinical Pharmacology and Therapeutics·Qi LiuRobert Temple

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