Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam
<p><strong>Background</strong> 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 grea...
| Main Authors: | , , , , , , , |
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| 格式: | Journal article |
| 语言: | English |
| 出版: |
BioMed Central
2023
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| _version_ | 1826311148589285376 |
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| author | Nguyen, YHT Dang, TT Lam, NBH Le, PT Nguyen, PH Bull, S Kestelyn, E Van Nuil, JI |
| author_facet | Nguyen, YHT Dang, TT Lam, NBH Le, PT Nguyen, PH Bull, S Kestelyn, E Van Nuil, JI |
| author_sort | Nguyen, YHT |
| collection | OXFORD |
| description | <p><strong>Background</strong> 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.</p>
<p><strong>Objectives</strong> 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.</p>
<p><strong>Methods</strong> 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.</p>
<p><strong>Results</strong> We use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.</p>
<p><strong>Conclusions</strong> 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.</p> |
| first_indexed | 2024-03-07T08:04:05Z |
| format | Journal article |
| id | oxford-uuid:beb0605f-1901-4ab4-aeff-0d2497a8b5b5 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T08:04:05Z |
| publishDate | 2023 |
| publisher | BioMed Central |
| record_format | dspace |
| spelling | oxford-uuid:beb0605f-1901-4ab4-aeff-0d2497a8b5b52023-10-16T15:13:21ZFragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, VietnamJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:beb0605f-1901-4ab4-aeff-0d2497a8b5b5EnglishSymplectic ElementsBioMed Central2023Nguyen, YHTDang, TTLam, NBHLe, PTNguyen, PHBull, SKestelyn, EVan Nuil, JI<p><strong>Background</strong> 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.</p> <p><strong>Objectives</strong> 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.</p> <p><strong>Methods</strong> 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.</p> <p><strong>Results</strong> We use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.</p> <p><strong>Conclusions</strong> 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.</p> |
| spellingShingle | Nguyen, YHT Dang, TT Lam, NBH Le, PT Nguyen, PH Bull, S Kestelyn, E Van Nuil, JI Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam |
| title | Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam |
| title_full | Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam |
| title_fullStr | Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam |
| title_full_unstemmed | Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam |
| title_short | Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam |
| title_sort | fragmented understanding exploring the practice and meaning of informed consent in clinical trials in ho chi minh city vietnam |
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