Guidance to inform communication with bereaved relatives about patient participation in emergency and critical care trials before death

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Abstract
Background Research in emergency and critical care is essential to improve outcomes for critically ill patients, yet many patients lack capacity to provide informed consent at the point of enrolment. Alternative consent models, including research without prior consent, are therefore commonly used. When a patient dies before research participation can be discussed or consent sought, bereaved relatives may be unaware of research involvement. Despite this, few emergency and intensive care trial protocols include a process for informing bereaved families about research involvement before death, creating ethical and practical challenges for clinicians and researchers. Methods The ENHANCing Communication with bEreaved relatives about emergency and critical care trials (ENHANCE) study, collected evidence on the perspectives of bereaved relatives, clinical and research staff and medical examiners with relevant experience. Sixty-five participants took part between June 2023 and May 2024. This evidence was used to develop good practice guidance which is presented in this paper to support clinical and research staff in communicating with bereaved relatives, when a patient dies following enrolment in emergency or critical care research without prior consent. Results Research and/or clinical teams, with knowledge of the study, should discuss emergency or critical care research involvement with bereaved relatives as soon as appropriate after enrolment. We present recommendations for researchers to consider when designing emergency or critical trials including: 1) What should the research team consider at the study design stage? 2) Who should notify families and what information should they provide? 3) Could this communication form part of bereavement information materials? and 4) What should I consider when discussing research without prior consent with bereaved relatives? Conclusions The ENHANCE guidance addresses an important gap in current trial practice and supports transparent, compassionate communication aligned with the professional duty of candour.
Funding Information
  • Research for Patient Benefit Programme (23/YH/0052)

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