Beyond the protocol: integrating trauma-informed principles in clinical research with Intensive Care Unit survivors.

Trauma-informed care (TIC) is an important and influential construct being increasingly used in clinical contexts. The principles of TIC shape the way physicians, nurses, social workers, and other healthcare providers interact with patients, leading to better outcomes, yet TIC constructs are rarely used to shape and influence the conduct of clinical research-whether in medicine generally or, more specially, with intensive care unit (ICU) patients and survivors, an often heavily traumatized group who are the focus of this review. Relying on case studies and relevant patient vignettes, this paper argues for the broad implementation of TIC principles in ICU outcomes research to uphold principles such as beneficence, to minimize potential trauma, and to better honor the unique challenges of a large, growing, and often vulnerable population. ICU experiences often involve fear, terror, loss of control, and vulnerability, which can lead to lasting psychological impacts. For ICU survivors, the process of participating in research may inadvertently re-traumatize them through various pathways, including the informed consent process, potentially distressing questions, and the environment in which patients are seen, to name a few. This paper emphasizes critical factors such as safety, trust, and privacy in shaping patients' research participation, while outlining six key TIC principles: safety, trustworthiness and transparency, peer support, collaboration and mutuality, cultural considerations, and empowerment. By integrating these principles into clinical research practices, investigators can enhance participant welfare, reduce attrition, and improve data quality leading to better and more accurate outcomes and, most importantly, honor the humanity of participants.