Safety, quality & education

The Performance of the Surrogate Informed Consent Process for Critical Care Research: A Multi-Modal Study of Investigators, Coordinators, Surrogates, and Patients

ChestPublished Mixed-methods study

Authors' conclusion

This study identified several strategies that could enhance the surrogate informed consent process for critical care research.

Study context

Population
Principal investigators (PIs), research coordinators (RCs), surrogate decision makers approached about a critical care research clinical trial and, when possible, patients who had been critically ill, at US academic medical centers61 in focus groups/interviews
Participants
230 participants
Comparison
Surrogate decision makers (SDMs) and/or patients vs PIs/RCs
  • RCn = 105
  • PIn = 90
  • Surrogatesn = 27
  • Patientsn = 8
Outcome
Best practices for the surrogate informed consent process
Methodological detailsmulticentre, surveys, focus groups, semi-structured interviews
  • Multicentre
  • Surveys
  • Focus groups
  • Semi-structured interviews

Main finding

As reported in the abstract

  • All groups believed RCs (not PIs) should conduct consent: not authority figures, fewer perceived conflicts of interest
  • Surrogates appreciated waiting for an optimal time to initiate contact, physical space and a defined period to decide
  • Telephone/electronic consent felt less effective than in-person, but could include SDMs living far away
  • SDMs and/or patients vs PI/RCs: P < 0.0001
  • SDMs and/or patients vs PI/RCs: P = 0.0016
  • SDMs vs PI/RCs: P = 0.001
  • SDMs vs PI/RCs: P < 0.0001

Original publication

The Performance of the Surrogate Informed Consent Process for Critical Care Research: A Multi-Modal Study of Investigators, Coordinators, Surrogates, and Patients. Chest. Published 6 June 2025. doi:10.1016/j.chest.2025.05.038

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