Ethics & Engagement across the Wellcome Trust Major Overseas Programmes
Chi Phuong Le is a 2019 GHBN Bursary Fellow
Chi Phuong Le is a social research assistant in Oxford University Clinical Research Unit (OUCRU) Vietnam. She graduated with a Master’s degree in Public Health at Umea University, Sweden. She has been working on a project related to controlled human infection models with OUCRU Vietnam since December 2017. The aims of this project are to explore legal, ethical and social aspects related to human challenge studies, as well as the acceptability of different stakeholders for this type of clinical research. Additionally, she is very interested in gender issues in science, particularly in challenges that women must overcome to purse excellence in a science career.
My first application for Global Health Bioethics Network Bursary Fellowship Award was a feasibility study exploring the use of ethnographic methods in the Intensive Care Unit (ICU). We planned to conduct this study by using ethnographic methods to determine first, the acceptability of intrathecal injections among patients and their relatives in a clinical trial and second, the acceptability of a rehabilitation program among similar groups. We designed the acceptability study on intrathecal injections and submitted the protocol to the ethics committee in Hospital for Tropical Diseases in Ho Chi Minh in October 2018. Unfortunately, the project was not accepted due to following reasons:
1) Concerns regarding the trustworthiness of qualitative data, which might conflict with the research integrity of the clinical trial;
2) Safety considerations for severe patients;
3) Adding a consent process for the qualitative study prior to the trial intervention could delay treatment for patients.
This experience led us to design a new study on the experiences and perspectives of different stakeholders on integrating qualitative research into clinical settings. The aims of this study are to identify ethical and social challenges associated with qualitative research methods in healthcare settings, from multiple stakeholders’ perspectives and throughout the research process. We expect that the study outcomes could inform future National Guidelines for Ethics in Biomedical Research and other country and/or hospital level regulations related to qualitative research methods, including a checklist with required sections for qualitative research protocols, as well as guidance and criteria for qualitative research to take place in healthcare settings. The study protocol was submitted to National Ethics Committee on February 2020.
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