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Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.
Shepherd, Victoria.
  • Shepherd V; Centre for Trials Research, 4th floor Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK. Electronic address: ShepherdVL1@cardiff.ac.uk.
Contemp Clin Trials ; 95: 106054, 2020 08.
Article in English | MEDLINE | ID: covidwho-617394
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Decision Making / Informed Consent Type of study: Experimental Studies / Prognostic study / Randomized controlled trials / Systematic review/Meta Analysis Limits: Adult / Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2020 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Decision Making / Informed Consent Type of study: Experimental Studies / Prognostic study / Randomized controlled trials / Systematic review/Meta Analysis Limits: Adult / Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2020 Document Type: Article