Optimizing the Performance of the Surrogate Informed Consent Process for Critical Care Research

Optimizing the Performance of the Surrogate Informed Consent Process for Critical Care Research
Avallone Mantelli, C. Glaros, C. Tietbohl, K. Torres, D.C. Files, M.F. Mart, M.A. Matthay, K.E.A. Burns, D. Matlock, M. Wynia, M. Moss
American Journal of Respiratory and Critical Care Medicine, May 2025
Abstract
Rationale
Research in intensive care units (ICUs) is essential to improving care for critically ill patients; however, patients are often unable to consent for themselves. Surrogates are often required to participate in the informed consent process for critical care research, though how to best engage surrogates in this process remains unclear. This study seeks to identify best practices for conducting surrogate consent for critical care research.
Methods
We conducted a mixed-methods study including quantitative surveys with open-ended questions, focus groups, and semi-structured interviews with principal investigators (PIs), research coordinators (RCs), surrogate decision makers who had been approached about a critical care research clinical trial, and when possible, the patient who had been critically ill.
Results
In total, 230 individuals (105 RC, 90 PI, 27 surrogates, 8 patients) completed surveys, and 61 participated in focus groups or interviews. In both surveys and focus groups/interviews, participants across all groups believed that RCs (as opposed to PIs) should conduct the consent process, as RCs are not considered to be authority figures and have fewer perceived conflicts of interest that could influence surrogates decision-making. Surrogates appreciated it when research staff waited until an optimal time to initiate contact and were given physical space and a defined period to consider their decision before follow up with them. When compared to PI/RCs, surrogates and/or patients attributed more importance to seeing the research team as an additional resource in explaining the progress of the patient’s care and were appreciated having additional team members whom they perceived as advocating for adherence to clinical protocols for their loved ones (p<0.0001 and p=0.0016). Compared to PI/RCs, surrogates thought the written consent was more important and were less concerned with its length, (p=0.001 and p<0.0001). In general, all participants felt that phone and electronic consent was less effective than in-person consent, though these modalities could facilitate the process for distant surrogates. Consent timing, respect for surrogate decision-making autonomy, and clear communication of the patient’s presumed wishes were additional significant themes.
Conclusions
Our study highlights the need for better guidance for carrying out the surrogate consent process in ICU research and identifies several themes that could serve to develop recommendations including designating trained RCs as primary facilitators, improving consent timing and setting, and for implementing accessible consent documentation. This study supports developing standardized training and guidelines for the surrogate informed consent process that could be consistently applied by ethics review boards in reviewing consent processes for clinical care research.