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Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

Ethics Committee's feedback on the acceptability study of integrating qualitative research into medical studies and clinical trials

Warm greeting from Vietnam,

I hope you all are staying safe and strong during this challenging time.

In this blog post, I would like to give you an update and share some interesting points during the process of obtaining ethics approval from National Ethics Committee for my project.

For those who are not familiar with my project, it is entitled “Acceptability of integrating qualitative research into medical studies and clinical trials within hospital settings in Ho Chi Minh City”. The study aims to explore the ethical and social challenges associated with qualitative research methods in healthcare settings, from multiple stakeholders’ perspectives and throughout the research process. The study outcomes are expected to inform the policy makers in Vietnam about regulations and requirements for studies using 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 reviewed by the National Ethics Committee of Vietnam in April 2020.

Generally, the Ethics Committee (EC) appreciated the importance of the study. They acknowledged the value of qualitative research methods within clinical research and the challenges that the local ECs might face due to the lack of guidelines and regulations during the review process for studies using qualitative research methods. In terms of the study design, the EC agreed that a mixed method approach is feasible and appropriate to collect data in Vietnam. Despite the positive feedback, the study protocol also received several comments related to the phrase “stakeholders”, the sampling strategy and sample size in the study protocol.

Clarification of the phrase “stakeholders” in the title and objectives of the study is the first main comment from the EC. The EC understood that the stakeholders of qualitative research study do not only include EC members and researchers but also research administration, coordinators and even, participants. However, they indicated that using the phrase “stakeholders” in the title and objectives of the study might not represent clearly the scope of the study. As such, we replaced the phrase “stakeholders” by “ethics committee members and researchers” and added an expanded explanation of who could potentially be enrolled as stakeholders in the protocol.

The second main comments were about sampling and sample size of the study. In the protocol, we proposed to conduct the sudy at study sites having independent IRB/EC functioning to review clinical trials and other types of research in healthcare settings in Vietnam, with the focus on hospitals at different levels. The EC suggested that we consider involving medical universities and institutes in the sample size because they also have independent IRB/EC to review biomedical research. To respond, we agreed that we would start by identifying whether the IRBs/ECs from medical and public health universities review studies with qualitative research methods integrated within clinical research, and then decide how to involve them in the study as appropriate. We would also use snowball sampling to identify potential participants within the IRBs/ECs that might not be enrolled as study sites. Additionally, the EC suggested that we should also add other stakeholders (e.g: healthcare providers, patients and their relatives) as study participants. As the study focus on the perspectives of ethics committees members and the participation of study subjects in the review process for health related studies in Vietnam is not regulated clearly, we decide to not include these additional stakeholders at this time. However, we will discuss the the roles of research participants in the ethical review process with EC members and researchers during data collection.

Despite the delays in the process of obtaining ethics approval due to the impacts of COVID-19 pandemic, the study received ethics approval on August, 2020. Currently, we are engaging and building relationships with hospitals to prepare for data collection. I will update again after starting data collection.

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Comment by Dina Rippon on November 20, 2020 at 12:28

Dear Chi, Thank you so much for this detailed update. It's really good to hear what the ethics committee wanted you to change. You can't always guess what an EC will pick up on, what will concern them, etc, so it's really interesting to hear their comments. Congratulations on getting the ethics approval, and I wish you good luck with the data collection. Have you had to change your data collection methods because of covid restrictions? For example, were you planning in-person interviews that now have to be done by phone? Or are you no longer hampered by covid restrictions and can proceed with your data collection as you originally planned it? 

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