Guidance to inform research recruitment processes for studies involving critically ill patients



Woolfall, Kerry ORCID: 0000-0002-5726-5304, Paddock, Katie, Watkins, Megan, Kearney, Anna ORCID: 0000-0003-1404-3370, Neville, Katie, Frith, Lucy ORCID: 0000-0002-8506-0699, Welters, Ingeborg ORCID: 0000-0001-8734-994X, Gamble, Carrol ORCID: 0000-0002-3021-1955, Trinder, John, Pattison, Natalie
et al (show 10 more authors) (2023) Guidance to inform research recruitment processes for studies involving critically ill patients. JOURNAL OF THE INTENSIVE CARE SOCIETY, 25 (1). pp. 95-101.

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Abstract

<jats:p> Clinical research in intensive care units (ICUs) is essential for improving treatments for critically ill patients. However, invitations to participate in clinical research in this situation pose numerous challenges. Studies are frequently initiated within a narrow time window when patients are often unconscious and unable to consent. Consultations or consent discussions must therefore be held with consultees or representatives, usually the patient’s relatives. Conversations about research participation in this setting may be difficult, as relatives are often overwhelmed and may feel uneasy about making decisions on behalf of their relatives. In some circumstances, legislation allows doctors to act as consultees or representatives to enrol patients in research. However, there is little good quality evidence on UK stakeholders’ perspectives to inform how recruitment is carried out in ICU studies. The Perspectives Study collected evidence on the views of over 1400 stakeholders, including patients, relatives and healthcare practitioners, many of whom had first-hand experience of ICU treatment and research. This evidence was used to inform good practice guidance on recruitment of critically ill patients to research. Established social science methods and empirical ethics were employed to reflect the interests of stakeholders and justify recommendations. This guidance aims to bridge the gap between the legal frameworks and the realities of ICU studies and to ensure that research recruitment processes reflect the views of patients and families. Researchers and an expert Advisory Group brought different perspectives to interpreting the evidence to develop the guidance. In this article we present guidance for future ICU studies. </jats:p>

Item Type: Article
Uncontrolled Keywords: Guidance, clinical research, recruitment, consent, critical care
Divisions: Faculty of Health and Life Sciences
Faculty of Humanities and Social Sciences > School of the Arts
Faculty of Humanities and Social Sciences > School of Law and Social Justice
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 25 Sep 2023 08:18
Last Modified: 11 Mar 2024 18:47
DOI: 10.1177/17511437231197293
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3172996