دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam.
المؤلفون: Nguyen YHT; Oxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam. yen.nth@oucru.org., Dang TT; Oxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam., Lam NBH; Oxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam., Le PT; Hospital of Tropical Diseases, Ho Chi Minh City, Vietnam., Nguyen PH; 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., Bull S; 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., Kestelyn E; 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., Van Nuil JI; 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.
المصدر: BMC medical ethics [BMC Med Ethics] 2023 Jan 16; Vol. 24 (1), pp. 3. Date of Electronic Publication: 2023 Jan 16.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101088680 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6939 (Electronic) Linking ISSN: 14726939 NLM ISO Abbreviation: BMC Med Ethics Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2000-
مواضيع طبية MeSH: Informed Consent* , Physicians*, Humans ; Vietnam ; Family
مستخلص: Background: The 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.
Objectives: This 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.
Methods: We 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.
Results: We use the concept "fragmented understanding" to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.
Conclusions: Our 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.
(© 2023. The Author(s).)
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معلومات مُعتمدة: 096527 Wellcome
فهرسة مساهمة: Keywords: Clinical trial; Inequality; Informed consent; Motivations; Socio-cultural context; Understanding; Vietnam
تواريخ الأحداث: Date Created: 20230116 Date Completed: 20230118 Latest Revision: 20230207
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC9843952
DOI: 10.1186/s12910-023-00884-2
PMID: 36647039
قاعدة البيانات: MEDLINE
الوصف
تدمد:1472-6939
DOI:10.1186/s12910-023-00884-2