Often, patients do not have capacity to consent for themselves to take part in research. Researchers may have to seek consent from a patient’s family members instead. If family members are not available, a doctor not involved in the research, can give approval for a patient to take part in a study.
Little is known about what patients, family members, and staff think about how consent and recruitment for research is carried out in the ICU. So, we set up the Perspectives Study to explore their views.
Our overall aim was to produce good practice guidance for future medical studies taking place in the ICU.
Who carried out the study?
This study was organised by researchers at the University of Liverpool and funded by the Economic and Social Research Council. The study was supported by the National Institute for Health Research and adopted onto the Clinical Research Network portfolio.
An Advisory Group of people who have experience of ICUs as patients, their family members, doctors, nurses, and researchers have helped the research team with the study.
What did we do in the study?
We surveyed over 1400 ICU patients, family members, and staff across 14 hospitals in England. This included 333 patients, 488 family members and 588 members of ICU staff.
In this survey, we asked patients and family members about their experiences of being approached to take part in medical research while in the ICU, and their wider views on research in the ICU. We also asked staff about their experiences of approaching patients and family members about studies, and their wider views on ICU research.
We then interviewed 60 patients, family members and staff to explore their views in more depth.
What were the findings?
For a summary of some of the key findings, please see our plain language leaflet.
How are the findings being used?
We have used the Perspectives study findings to produce the Good Practice Guidance on recruitment and consent to medical studies in the ICU. The guidance development meeting in October 2019 was a key step in producing the guidance.
We also used the findings to produce a short video animation to help people understand about consent to research in the ICU http://shorturl.at/mrK26
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