The process of obtaining informed consent in clinical trials is intended to safeguard participants and support their autonomy. Nonetheless, implementing consent in a way that is truly meaningful remains a challenge in many settings, due to both practical difficulties and the influence of sociocultural dynamics. This study examined how informed consent is conducted and perceived in two clinical trials run by the Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam. A combination of qualitative approaches was used, including direct observation, interviews with physicians and participants, review of consent forms from 2009 to 2018, and engagement with patients’ family members. Seven physicians and twenty-five trial participants were recruited, with five physicians and thirteen participants completing in-depth interviews. Twenty-two observation sessions were also conducted. The concept of “fragmented understanding” emerged to describe participants’ varying comprehension of the consent process and to reveal the factors contributing to these differences. Findings highlight that both the conduct of consent and participants’ interpretations are shaped by individual characteristics and the broader sociocultural context in which clinical trials occur.
