Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam

BMC Medical Ethics

Research

Phuong Thanh Le¹  Ngoc Bao Hong Lam²  Yen Hong Thi Nguyen²  Thuan Trong Dang²  Evelyne Kestelyn³  Jennifer Ilo Van Nuil³  Phu Hoan Nguyen⁴  Susan Bull⁵ 

[1] Hospital of Tropical Diseases, Ho Chi Minh City, Vietnam;Oxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam;Oxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam;Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK;Oxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam;School of Medicine, Vietnam National University, Ho Chi Minh City, Vietnam;The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK;Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand;

关键词: Informed consent;    Clinical trial;    Understanding;    Motivations;    Socio-cultural context;    Inequality;    Vietnam;   

DOI  :  10.1186/s12910-023-00884-2

 received in 2022-09-30, accepted in 2023-01-09,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.ObjectivesThis study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.MethodsWe used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.ResultsWe use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.ConclusionsOur findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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