Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

Exploring informed consent: practices and perceptions of the informed consent process in a clinical trials setting in Vietnam

Nguyen Thi Hong Yen is a 2018 GHBN Bursary Fellow


Yen is currently a Social Science Research Assistant in the Oxford University Clinical Research Unit (OUCRU) in Ho Chi Minh City, Vietnam. She is based in the Clinical Trials Unit, conducting a study on the consent process in on-going clinical trials. Yen has a Master’s Degree in Social and Cultural Anthropology from KU Leuven, Belgium. Her research interests include ethical challenges in health research in multiple settings and cultural contexts.

Project outline:

Informed consent is one of the important elements in good clinical practice guidelines to prevent exploitation in research. Despite the growing number of clinical trials in Vietnam, there is little knowledge about the consent process and participant and healthcare providers’ perceptions of it. We conducted a social science study alongside two on-going clinical trials at the Hospital of Tropical Diseases in Ho Chi Minh City to explore perceptions and practices of consent within clinical trials. We used a variety of qualitative methods including document review of consent forms used onsite for the past ten years, direct observations, surveys, in-depth interviews, and participant observation.

Selected Findings
Based on findings, research participants held three levels of understanding regarding the consent process, which we term “broken understanding”. First, some participants had no understanding of the information included during the informed consent process. Second, participants had partially correct understanding about the clinical trial, which demonstrates that a certain level of information is essential to provide. Third, participants only understood information emphasized by study doctors during the consent process, such as study procedure and their responsibilities, but had no understanding of the rest.

The researchers also spoke about communication challenges during the consent process due to older age, low literacy, and the health conditions of research participants. Participants’ previous healthcare experiences as well as the patient-doctor relationship, more broadly, prevented participants from asking questions when they did not understand the given information.

Finally, we found that one of the main motivations for the patients to enroll in a clinical trial was their hope for a cure and these decisions about joining were made in the context of unequal access to healthcare more broadly.


The “broken understanding” form a shattered reflection of the fundamental elements of informed consent as information was selectively explained and understood. We argue that it was not just the result of communication faults, but of structural deficiencies. Poverty, trust in healthcare workers, and the limitations of healthcare systems left participants an “empty choice” (Kingori 2015). With this argument, we would like to emphasize the importance of structural faults in the current issues of informed consent in a resource-poor context and to move away from the conventional blame of a specific individual or study.

Add a Comment

You need to be a member of e-MOPs to add comments!

Join e-MOPs

© 2022   Created by Dina Rippon.   Powered by

Badges  |  Report an Issue  |  Terms of Service