Balancing altruism, risk and ethics: Vietnamese students' views on human challenge studies.

Abstract

Human challenge studies (HCS) have been proposed to accelerate the development of health interventions and strengthen research capacity in low- and middle-income countries. However, implementation in settings such as Vietnam, where clinical care facilities and research capacity are limited and no specific regulatory framework for HCS exists, raises special ethical, social, and practical concerns. This study examined healthcare professional students' perceptions of and attitudes toward HCS, focusing on ethical considerations and factors associated with willingness to participate. A mixed-methods study was conducted as part of a longitudinal project, named SEED (2020-2024) among students at the University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam. Quantitative data was collected using a structured survey administered after engagement activities on HCS (n = 242). Qualitative data were obtained through focus group discussions (n = 54) and in-depth interviews (n = 14). Findings were integrated using an explanatory mixed-methods approach. Participants reported moderate familiarity with HCS and expressed cautious support. Acceptability of HCS was lower than that of clinical trials or observational studies, reflecting concerns related to intentional infection. Motivations for participation included altruism, perceived social value, and potential national benefits, particularly for endemic diseases. Willingness to participate was positively associated with assurances of participant safety, access to rescue treatment, long-term compensation for research-related harm, transparent informed consent processes, and trust in research institutions and regulatory oversight. Concerns about potential health risks, psychological burden, time commitment, fairness of compensation, stigma, and family influence were significantly highlighted. Medical and public health students in Vietnam expressed conditional support for HCS, while balancing perceived benefits against ethical and practical concerns. Establishing clear governance mechanisms, risk mitigation strategies, and appropriate compensation frameworks will be critical for ensuring the ethical conduct and acceptability of HCS in similar settings.