ENHANCE

• Research type

  Research Study

• Full title

  Enhancing communication with bereaved relatives about emergency and critical care trials

• IRAS ID

  324927

• Contact name

  Kerry Woolfall

• Contact email

  k.woolfall@liverpool.ac.uk

• Sponsor organisation

  University of Liverpool

• Duration of Study in the UK

  1 years, 3 months, 31 days

• Research summary

  Involving critically ill patients in research is important to help find treatments that save lives. Critically ill patients may be entered into a study without prior consent when there is no time to discuss research with relatives. A patient enrolled in a study may sadly die, and sometimes bereaved families do not know that their relative was part of a study. If information about patients who die is not included in research, the results may be unreliable, as it would be unclear if study participation leads to higher rates of death.

  Doctors can struggle to know when, or whether it is appropriate to disclose a deceased patient’s research involvement to grieving family members.

  The purpose of the study:
  We aim to find out if bereaved families wish to be informed about their relatives’ participation in research and if so, when and how they would prefer to be told. We also want to find out if it is possible and appropriate for doctors to add information about research participation into their discussions with bereaved families as part of the medical examiner system.

  What we will do:
  Medical Examiners (MEs) will identify patients who were involved in a trial and ask their family members if they were aware of the patient’s study involvement and if they would like more information about this. The ENHANCE researcher will conduct interviews with bereaved families, with MEs and with research staff to find out the best way to communicate with families after the death of a patient involved in a trial. Findings will be used to develop recommendations for future emergency and critical care studies. Importantly, this work will help improve experiences for bereaved families as their thoughts and experiences will have been considered. Study findings will be published, including a summary for patients and health professionals.

  Lay Summary of Results:

  Background to the research
  Involving critically ill patients in research is important to help find treatments that save lives. Patients can be entered into a study without prior consent when there is no time to discuss research with relatives. A patient enrolled in a study may sadly die, and sometimes bereaved families may not be aware that their relative was part of a study. Doctors can struggle to know when, or whether it is appropriate to disclose a deceased patient’s research involvement to grieving family members.

  The purpose of the study
  We wished to find out if bereaved families want to be informed about their relatives’ participation in research and if so, when and how they would prefer to be told.

  What we did
  Medical examiners identified patients involved in research (as part of their usual contact with relatives) and asked their family members if they were aware of the patient's study involvement and if they would like more information. Researchers conducted interviews with bereaved families, and medical and research staff to find out their views on communicating with families after the death. Recommendations were written for future research.

  Public involvement
  Bereaved families helped ensure this sensitive research was conducted appropriately.

  Key Findings
  Our findings suggest that most, but not all families wish to be informed about their relative’s trial participation. We provide guidance to inform future research in these settings.

  Dissemination, outputs and impact

  The ENHANCE guidance is available on the Health Research Authority website and has been disseminated to national NHS Research Ethics Committees as best practice. A plain English summary of the findings will be available at: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.liverpool.ac.uk%252Fpopulation-health%252Fresearch%252Fenhance%2FNBTI%2F9_zFAQ%2FAQ%2Fe591450f-17ec-46e6-bff4-6239c94cb970%2F1%2FR277babJYM&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7Cfa08cf17c3df4a1884ef08dec63eea7f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639166170736487366%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=zqNl3fD6MF7u6rnY89aqBWqFQ869jKRIVb2YFUFINI0%3D&reserved=0

  The results paper is available at: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fbmjopen.bmj.com%252Fcontent%252Fbmjopen%252F16%252F2%252Fe106677.full.pdf%2FNBTI%2F9_zFAQ%2FAQ%2Fe591450f-17ec-46e6-bff4-6239c94cb970%2F2%2FRzzarfsQJ2&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7Cfa08cf17c3df4a1884ef08dec63eea7f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639166170736534647%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=vTx7ETBi1Go3txnATDYHxrGOveHvppHXpF0qnJS%2FZOU%3D&reserved=0

  Conclusions and Future Plans
  We plan to communicate the ENHANCE guidance to all relevant groups so that future research studies include options for notifying bereaved families about research involvement if they should wish to find out.

  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: Not Applicable

  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: Presented at: The international Clinical Trials Methodology Conference, September 2024 and the UK Critical care research group, September 2025

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  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fbmjopen.bmj.com%252Fcontent%252Fbmjopen%252F16%252F2%252Fe106677.full.pdf%2FNBTI%2F9_zFAQ%2FAQ%2Fe591450f-17ec-46e6-bff4-6239c94cb970%2F2%2FRzzarfsQJ2&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7Cfa08cf17c3df4a1884ef08dec63eea7f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639166170736589658%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=fVOJP8VcuBguuSz9Cxzp1amfIedMTVXPpM0fi2%2FN1EY%3D&reserved=0
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Pending
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected: 12/07/2026
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: No data are available. The datasets generated are not publicly available as consent was not sought for data sharing.
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: N/A
  Captcha: 0cAFcWeA7G_Hmif2RI2l_lQeeRM5GMjUIVJztOaPF0lEKhkmSOUXKLnEsJfhds46eRQx2T0OlA6WTjNfE8jEwjozzZ8nihehDvdUocNd414Diawfy83VhHlTMDLmtMrAXLCIMqCT2j-zLj_6IHGxdTIWwlfouMs-r0ETdraYuvK3Aj_Exg77PmFw0mBCSIPy4X27HfNKOP0bskiDn2H6hecB_XxysOCbDeSV8uHmp4eQY1mELDbaYnW49MW2O8nac9uzBuUG1NSjFUn1d-5jIlzpGsmPFseCMXtMgn15T8FHMN39kKH-D4h8WeEnBEPnsr-NmTDze_CMKAL4jOKO8XFsfMqyAWNuv7gaWdCb2juKCltmCckN7a0Zl0uygL_qoVoZUK8H-46zL_Vg3qLoBNFCXiW-yaV20wqKPJO7sn2Y1kGeJt0Ue1qx67GuWftBMzdiI-wm7uEBZzL61AvJnEHwr5c6osPK5NLlOouhBmQis_CNKxCtI4Kx3E3BR_teDrNPWVjG2r17SCaTGiCH2Fz-MIZokTvEOyyXLcENgCw1bK24oyVHynkswyICf9lZwhvDdKYBD3tF9noEpQVDn-W4l9MY0Ta7YgyZRJUqSavBpBI5CHii0PdeAKtagJYw7_Q0IbljzwR3QhAHez6k4N9IiKs07PZKZrO8GS52POg9dd--vHD1H_TuJKTG3YU02lLY7W0d-cUkbhlvkyttoa_4UfeSoOKnkjCDQcBgBESj2YQqj4dz9ccYMuv3gsrnfzb8jeSGcDUH1qp4dH3cen-1J6_lM5q9sBGnyQQaYpsPpdk66zCJYU1WrrdFjc9SjE4kFUg6iP5GK6zgcD-Wo7ZBIOOdOKUaoTh0G1l5zyiQ1zLDWh654I4ve4FJR-dPqAt19bSBm3wvgdaQg-1tZMybQS7WV5GRutkGAQSn9P0ryImFAmomJ3lN86tFVwBjarmUS9r4O8UvMSEO8vXjsUcPqQ7Du5HhRw4aKLxT-5Zu-1xFdTSwzg_WbC1l6FL552RaDT8rys0ox5i-uCW1MjaYBD9ui0MVycxA
  

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  23/YH/0052

• Date of REC Opinion

  17 Mar 2023

• REC opinion

  Favourable Opinion