The Perspectives Study: From Evidence to Guidance on Patient Recruitment to Clinical Research in Intensive Care Units, 2016-2019

Young, Bridget ORCID:, Woolfall, Kerry, Frith, Lucy, Gamble, Carrol, Welters, Ingeborg and Paddock, Katie (2021) The Perspectives Study: From Evidence to Guidance on Patient Recruitment to Clinical Research in Intensive Care Units, 2016-2019. [Data Collection]

External DOI: 10.5255/UKDA-SN-854286


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. ICU studies frequently take place within a narrow time window and patients will often be unconscious and unable to consent. Consent must, therefore, be sought from representatives or proxies of a patient, usually the patient's relatives. Conversations about research participation in this setting will be difficult, as relatives are often overwhelmed and some will feel uneasy about making decisions on behalf of their loved ones. In some circumstances, legislation allows doctors act as representatives so patients can be enrolled in research. Despite these and other distinctive practices in recruitment and consent to ICU research, prior to the Perspectives study there was little good quality evidence and guidance on stakeholders’ perspectives to inform how recruitment and consent is carried out in ICU studies. Knowledge of stakeholder perspectives was needed to avoid basing recruitment and consent processes on presumptions about peoples’ experience of ICU research. The Perspectives study explored the views of stakeholders with recent first-hand experience of ICU treatment and research to inform approaches to recruitment and consent. Established social science methods and empirical ethics were employed to balance the interests of the various stakeholders and justify recommendations. The findings were used to inform good practice guidance on recruitment and consent to future ICU studies. Researchers and an expert Advisory Group of key stakeholders (including patients, relatives, ICU doctors, nurses and research regulators) contributed throughout the process of developing the guidance bringing different viewpoints to interpreting the evidence and informing the guidance.

Keywords: Psychology, Sociology, Ethics, Consent, Stakeholder, ICU, Trial recruitment.
Divisions: Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Judith Carr
Date Deposited: 09 Nov 2021 15:36
Last Modified: 09 Nov 2021 15:36
DOI: 10.5255/UKDA-SN-854286
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