Title: From evidence to guidance on patient recruitment to clinical research in intensive care units
Funder: Economic and Social Research Council

Abstract: Clinical research in intensive care units (ICUs) is essential for improving treatments for critically ill patients. However, being invited to consider research participation in this situation is far from straightforward. 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, usually the patient's relatives. However, conversations about research particiation may seem peripheral to relatives, who, overwhelmed and struggling to absorb information, will want the focus to be on the clinical care of the patient. Relatives may also feel uneasy about making decisions on behalf of their loved ones. Given that a quarter of ICU patients do not survive and many others will experience long-term health problems, there is also the possibility that a patient's poor outcome may be associated with their participation (or non participation) in research, bringing the risk of blame and regret. Further challenges arise in studies of emergency treatments for ICU patients, where any delay in seeking consent before enroling the patient (and implementing the treatment being studied) could have serious consequences for the patient, and potentially invalidate the study. In such circumstances, legislation allows doctors to give the treatment that is under investigation and seek consent later, a process known as 'deferred consent'. Unfortunately some patients will die after being entered into a study but before the research has been discussed with relatives. For grieving relatives, learning that a deceased loved one has received treatment as part of a research study could be intensely distressing. For the doctors and nurses who have the responsibility for explaining the research to bereaved relatives, such encounters will be daunting, yet there is little systematic knowledge for them to drawn on in approaching bereaved relatives about research in these circumstances. The recruitment of patients to ICU studies therefore poses numerous and intense challenges. Despite these challenges, there is little good quality evidence and guidance on patient and other stakeholder perspectives to inform how recruitment and consent is carried out in ICU studies. Among the many questions facing those who design and conduct ICU studies are: what are the most appropriate methods and timing for seeking consent; which staff members should be involved and how should they be trained; what information should be provided to patients/relatives and how should health practitioners support their decisions? For these and other questions, knowledge of stakeholder perspectives is needed if we are to avoid continuing to base recruitment and consent processes on presumptions about how people experience ICU research. Our project will use established social science research methods to investigate the perspectives of stakeholders who have recent first-hand experience of ICU treatment and research. We will explore their views of research, the different methods for recruiting patients and seeking consent, and examine how their perspectives can inform approaches to the challenges outlined above. Once we have collected and analysed this information we will use it to inform good practice guidance on recruitment and consent to future ICU studies. We will draw on methods, called empirical ethics, to ensure that this guidance is well justified and balances the interests of the various stakeholders. However, there are questions about how knowledge of stakeholder perspectives should be used to inform guidance. To address these we will involve a team of researchers and an expert Advisory Group of key stakeholders (to include patients, relatives, and other stakeholders) who bring different perspectives to interpreting the evidence and carefully document how the different perspectives inform the guidance.


Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: GENERIC HEALTH RELEVANCE