ENHANCing Communication with bEreaved relatives about emergency and critical care trials (ENHANCE)
ENHANCE was the first study to assess and explore potential communication strategies with bereaved families when their relative has died following enrolment into an emergency/critical care trial, without prior informed consent.
Our research
Clinical research in emergency or critical care settings is vital, yet the process of recruitment and consent is practically and ethically complex, particularly as only around 10% of ICU patients can provide informed consent for research and there is a high risk of mortality amongst severely ill patients.
Many emergency and critical care trials do not inform bereaved relatives of their family member’s enrolment in research, possibly due to a belief that disclosure would add to distress for bereaved relatives. However, decisions not to inform families have often been driven by the views of researchers and practitioners rather than the wishes of bereaved families themselves.
Between June 2023 and May 2024, 63 participants took part in either a survey and/or interview and 38 took part in a guidance development workshop. This included bereaved relatives, doctors, bereavement nurses, research nurses and medical examiners. The study was led by Professor Kerry Woolfall (University of Liverpool) and Dr Joanne Euden (Cardiff University).
ENHANCE findings suggest that most, but not all families wish to be informed about their relative’s trial participation. It is important to respect the wishes of families who do not wish to be informed and find a solution that accommodates all perspectives. ENHANCE guidance has been developed to inform future research in these settings.
Who is this guidance for?
The ENHANCE guidance is for all those with a direct or indirect role in the funding, design, conduct, governance, and ethical review of emergency and critical care studies involving adults.
Download guidance
Reference: Woolfall, K., E. Deja., H. Doughty., B. Young., I. Welters., V. Shepherd., S. Milosevic; K. Pool; J. Carman., V. Sankar., E. Thomas-Jones; J. Euden (2024). Guidance to inform communication with bereaved families about their relatives' participation in emergency or critical care research without prior informed consent. ENHANCE Study Guidance Version 1.0. Liverpool, UK: https://www.liverpool.ac.uk/population-health/research/enhance
Funding
The ENHANCE study was funded by the National Institute for Health and Care Research: Research for Patient Benefit - Ref NIHR204067.
