Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: a decade in review

Shepherd, Victoria ORCID: https://orcid.org/0000-0002-7687-0817 2020. Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: a decade in review. Contemporary Clinical Trials 95 , 106054. 10.1016/j.cct.2020.106054

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Abstract

Informed consent is an essential requirement prior to clinical trial participation, however some ‘vulnerable’ groups, such as people with cognitive impairments and those in medical emergency situations, may lack decisional capacity to consent. This raises ethical and practical challenges when designing and conducting clinical trials involving these populations, who are frequently excluded as a result. Despite recent advances in improving informed consent processes, there has been far less attention paid to the enrolment of adults lacking capacity. Exclusion criteria are an important determinant of the external validity of clinical trial results. The exclusion of these populations, and consent-based recruitment biases which arise from the challenges of identifying and involving surrogate decision-makers, leads to trials which are not representative of the clinical population. This article discusses the involvement of adults who lack decisional capacity to consent in clinical trials and presents the advances over the previous decade and the remaining ethical challenges for the inclusion of this under-represented population in research.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine Centre for Trials Research (CNTRR)
Publisher:	Elsevier
ISSN:	1551-7144
Date of First Compliant Deposit:	16 June 2020
Date of Acceptance:	3 June 2020
Last Modified:	07 Nov 2023 04:49
URI:	https://orca.cardiff.ac.uk/id/eprint/132543

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