Approaches for Establishing Trust and Alleviating Stress During the Surrogate Informed Consent Process for Critical...

Trust with researchers is a consideration among surrogate decision makers (SDMs) who are approached to provide consent for research participation on behalf of critically ill patients. However, little is known about strategies that researchers can use to build trust with SDMs and alleviate stress when making these decisions.

What are the best approaches to building trust and alleviating stress that can be used in the surrogate informed consent process?

This convergent parallel mixed-methods study included surveys, focus groups, and semi-structured interviews with principal investigators (PIs), research coordinators (RCs), SDMs, and critically ill patients who were approached for participation in a critical care research clinical trial. Surveys captured opinions regarding trust and stress in the surrogate consent process, and qualitative findings described factors that influenced the trust and stress of the SDMs in this context.

Overall, 230 individuals (90 PIs, 105 RCs, 27 SDMs, and 8 patients) completed surveys, and 61 (24 PIs, 23 RCs, 11 SDMs, and 3 patients) participated in focus groups/interviews. Three approaches were identified that participants described across data sources as significant for establishing trust and reducing stress among SDMs: (1) humanizing research participation; (2) tailoring approaches to patient/SDM background (eg, race, location, prior research experience); and (3) transparent communication about study details. Participants felt that researchers first needed to show that they were considering the patient as "a person," not as a study participant. Taking time to learn about and address aspects of the patient's or SDM's background was important, as was the manner in which study details were communicated. Although all participant groups largely agreed about the relevance of these factors, some differences between groups were noted.

Three strategies were identified that PIs, RCs, SDMs, and patients viewed as effective for building trust and alleviating stress in the surrogate informed consent process. Incorporating these approaches could enhance trust and participation in critical care research.