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Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

Updates from the Informed Consent study in Vietnam

Warm greetings from Vietnam.

I would like to you give you some updates about my GHBN bursary project which explores the perceptions and practices of informed consent in clinical trials in a hospital setting in Vietnam. The study is being conducted in OUCRU Vietnam and the Hospital of Tropical Diseases in Ho Chi Minh City. In the study, I work with study doctors and potential participants from three different clinical trials doing research on Hepatitis C and Tuberculosis meningitis. Data collection methods include observations, surveys, in-depth interviews and focus group discussions.

After nearly five months, I received ethics approval for my study. The process of obtaining ethics approval from the local IRB was quite challenging because the IRB members did not have much experience in reviewing qualitative research protocols. Although the process of obtaining ethical approval was quite long and challenging, it gave me important understanding of the local IRB’s perceptions of qualitative research.

As I am conducting the research within three different clinical trials and each has their own way of conducting research and recruiting participants, it is a challenge for me to find a suitable pathway to work with each of them. Therefore, I am still in the phase where I get to know people in the wards,  learn about my study participants and look for a friendly way for collaborating. I am trying to spend some time in the wards every day so that the healthcare staff can learn my face and be comfortable with me being around them. Engaging with the clinical trials teams and building relationships and rapport are crucial and part of our process of doing fieldwork. Until now, I have recruited seven healthcare workers and three patients into the study.

I will update again after having more interesting experiences during data collection.

Thank you and best wishes to all.

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Comment by Dina Rippon on April 11, 2019 at 17:17

Dear Yen, thank you for this great update! I'm sorry to hear about the challenging ethics approval process - several of our Bursary Fellows have had to deal with long and difficult ethical approval processes. I'm curious as to what the IRB members found difficult about your proposal - were there specific issues they highlighted which they didn't understand? How did you manage to resolve these difficulties? Having been through the ethical approval process, do you have any advice, or 'lessons learned' that you can share here that might be useful to future Bursary Fellows? Thanks again for the interesting summary!

Comment by Michael Parker on April 12, 2019 at 11:06

Dear Yen. Thank you so much for the update. It sounds like you learnt a lot from the ethics review process. I'm sorry to hear it took such a long time but, as you say, it provides a really interesting insight into the challenges of doing ethics and social scientific research. I am so happy to hear that you are now able to start the process of building relationships, getting to know the context etc. I'm really looking forward to seeing how the project progresses. Thank you very much once again for the update.

Comment by Nguyen Thi Hong Yen on April 17, 2019 at 11:53

Dear Dina and Mike,

Thank you so much for your kind support to the study.

In this study, I am using direct observation method meaning that I have to observe the consenting session of the clinical trial. In order to do that, I need to obtain consent from the patient and doctor before the clinical trial’s consent. The IRB members in HTD concerned that many consenting sessions may delay emergent treatments to severe patients in TB studies. Therefore, we amended our protocol by working with patients with mild conditions only.  

Besides, the IRB members also had questions about ethnographic and qualitative methodology such as participant observation, focus group discussion, sample size, and data generalization. I learned that the IRB members had not had many experiences with social science before. So, the clearer and more detailed explanations we give them, the better understanding of our study they may gain.

Another challenge that we faced was the use of term “perception” in the study title in Vietnamese language. The first translation was commented as “abstract”, so we had to change to another word that is more familiar to the IRB members.

These challenges were very specific to my study and the IRB at HTD. I think the best way overcome the challenges is gaining understanding from both sides through communication and engagement. Having good understanding of the local IRB might also help us to prepare a better submission.

Best wishes,

Yen

Comment by Dina Rippon on April 17, 2019 at 17:44

Dear Yen, 

Thank you so much for that detailed explanation. It really provides a clearer picture of the particular challenges you faced in your study. It also provides some insight into the thinking process that IRB members go through - very helpful! Thank you!

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