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

被引:1
作者
Nguyen, Yen Hong Thi [1 ]
Dang, Thuan Trong [1 ]
Lam, Ngoc Bao Hong [1 ]
Le, Phuong Thanh [2 ]
Nguyen, Phu Hoan [1 ,5 ]
Bull, Susan [3 ,4 ]
Kestelyn, Evelyne [1 ,6 ]
Van Nuil, Jennifer Ilo [1 ,6 ]
机构
[1] Univ Oxford, Clin Res Unit, 764 Vo Kiet,Ward 1,Dist 5, Ho Chi Minh City, Vietnam
[2] Hosp Trop Dis, Ho Chi Minh City, Vietnam
[3] Univ Oxford, Ethox Ctr, Nuffield Dept Populat Hlth, Oxford, England
[4] Univ Auckland, Fac Med & Hlth Sci, Dept Psychol Med, Auckland, New Zealand
[5] Vietnam Natl Univ, Sch Med, Ho Chi Minh City, Vietnam
[6] Univ Oxford, Ctr Trop Med & Global Hlth, Nuffield Dept Med, Oxford, England
关键词
Informed consent; Clinical trial; Understanding; Motivations; Socio-cultural context; Inequality; Vietnam; RESEARCH CONTEXTS; COMPREHENSION; QUALITY; TRUST;
D O I
10.1186/s12910-023-00884-2
中图分类号
B82 [伦理学(道德学)];
学科分类号
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.
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页数:13
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