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Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

End of project updates: Practices and perceptions of the informed consent process in a clinical trials setting in Vietnam

Dear Colleagues,

Hope you all are doing well. I would like to give you an update of my project exploring the practices and perceptions of informed consent process in a clinical trial context in Vietnam.

We worked along side two on-going clinical trials including an out-patient clinical trial which was a non-randomised trial and an in-patient clinical trial which was a randomised controlled trial in OUCRU and the Hospital of Tropical Diseases in Ho Chi Minh City. We expected to see differences in the informed consent process between these two clinical trials. The study used qualitative methodology with different data collection tools including document review, direct observation, surveys, in-depth interviews and participant observation.

I would like to summarise major findings of the study in the following paragraphs.

Document review

In this study, we reviewed the clinical trial consent documents used by OUCRU Vietnam from 2009 until 2018 to provide a baseline of the content and form of the consent process. Overall, we found the forms have not changed much in the last ten years. Similarly, the guidelines did not have any major changes during the assessed period. The core information of clinical trials, such as study purpose, study design and procedure, risks and benefits, was consistently included in all forms over time. Challenges in translation and simplicity of content were observed during the review.

The practice of informed consent in clinical trials

The practice of informed consent was mainly documented through direct observation and in-depth interviews. We observed the consent processes which were done by four different healthcare workers and with twenty-two patients in two clinical trials. We found that each healthcare worker had different communication styles for explaining the information to their patients. However, all healthcare workers highlighted that all major information of the research including the study purpose, procedure, benefits and risks, interventions, and voluntariness were essential to inform their research participants. Twenty minutes was the average duration of the informed consent process. The time was also confirmed by the study doctors as the average time for consenting. They revealed that having a long consent process could either confuse their patients or fatigue them, especially when they were very sick. The patients had time to ask questions. After the patient had no questions about the clinical trial and agreed to join the study, both sides signed on the informed consent form and each kept one copy.

Broken understanding of clinical trial information

The concept “broken understanding” refers to the lack of full understanding of clinical trial information. Data from in-depth interviews and surveys indicate that research participants showed three levels of understanding of the disclosed information. First, some participants had no understanding of what was disclosed in the informed consent process. Second, research participants had partially correct understanding about the clinical trial. This level of understanding shows information that is essential to the research participants as well as the process of making sense of the information they received and their experiences in the clinical trials even though the reproduced knowledge might be incorrect. Third, research participants only understood information emphasized by study doctors in the consent process, such as study procedure and their responsibilities, but had no understanding of the rest. The three levels of understanding formed a broken reflection of the universal fundamental elements of informed consent.

Communication challenges

Communication skills have been emphasised as important for doctors, especially for those who obtain informed consent. However, how skillful a doctor was, the challenges were still there. Senior age, low literacy, and health conditions of research participants were reported as the most faced challenges affecting patients’ capacity to understand a complex clinical trial. The unbalanced patient-doctor relationship and previous negative healthcare experiences prevented the patients from asking questions when they did not comprehend the given information.  Using lay language and adapting the speaking style to each individual were common strategies to enhance the comprehension of information. In the randomised controlled clinical trial, we found creative strategies that study doctors employed in an effort to improve understanding of the research participants, such as inviting different family members to the informed consent process or suggesting the potential participants talk with current research participants about their experiences in the study.

Structural challenges

We will use the concept of “structural coercion” from Fisher (2013) and “empty choice” from Kingori (2015) to argue that “broken understanding” of clinical trial information in Vietnam is not just the result of communication faults, but of a structural deficiency. Our study found that the biggest motivation for the patients to sign up in a clinical trial despite of the lack of information was their hope for a cure. The structural coercion as explained by Fisher (2013) is the social and economic situation of the patients leaves them no choice but to join a clinical trial in order to access treatment or health examinations. Here, we refer to poverty, trust in healthcare workers and the limitations of healthcare systems as “structural coercion” that prevents the patient from making a meaningful choice. When patients are left a choice but actually no choice at all, Kingori (2015) called it an “empty choice”. With this argument, we would like to emphasize the importance of structural faults in the current issues of informed consent in a resource-poor context and to move away from the conventional blame of a specific individual or study.

Public Engagement

I received a Public Engagement Seed Award to work on interventions to improve the informed consent process in clinical trials in OUCRU. The study results suggest that research participants had broken understanding of the trial’s information. Therefore, in the PE project, we tried to disclose more information to the research participants by providing them a support document with frequently asked information about the disease and the clinical trial. Another major finding of the study was that the informed consent form was not friendly enough to readers who are in their senior age with bad eyesight. We created new design of the current informed consent form used in the two clinical trials. The new version had no change in content, but had larger font size, larger line spacing and included illustrating icons. We conducted two focus group discussions with clinical trial participants to hear their feedback about the proposed interventions, and received positive responses from them. We also discussed the study findings and interventions with the Clinical Trial Unit. I hope that the study findings and interventions will provide a useful baseline for further studies to improve ethical practices in our organisation.

I would like to express my gratitude to the GHBN for their funding and support during the project. I have learned and practiced new skills and knowledge, which I believe are fundamental for my future studies. Besides, I have met many great people from the Summer School and other workshops since I started the work. I am currently writing a manuscript, so any comments and ideas for improving it are welcome.

Thank you so much and best wishes.

References

Fisher, J. A. (2013). Expanding the Frame of “Voluntariness” in Informed Consent: Structural Coercion and the Power of Social and Economic Context. Kennedy Institute of Ethics Journal, 23(4), 355-379. doi:10.1353/ken.2013.0018

Kingori, P. (2015). The 'empty choice': A sociological examination of choosing medical research participation in resource-limited Sub-Saharan Africa. Curr Sociol, 63(5), 763-778. doi:10.1177/0011392115590093

Views: 83

Comment by Dina Rippon on January 27, 2020 at 13:14

Dear Yen, thank you so much for this comprehensive summary of your Bursary project! You certainly accomplished a lot! It is very interesting to read about the communication challenges and structural challenges that you came across. It's also interesting to hear about your success in improving the appearance of the informed consent forms for those with poor eyesight - amazing that just a couple of small changes can make such a big difference to participants' understanding. Congratulations on all your hard work! Please keep us updated on the progress of your manuscript! 

Comment by Alex Nginyo Hinga on January 27, 2020 at 13:44
Congratulations Yen! I find your linkage of data with concepts (structural coercion, empty choice) really interesting. I look forward to reading more about this project.
Comment by Michael Parker on January 28, 2020 at 10:55

Dear Yen,

This is a fantastic report and summary of your research. It is wonderful to see how much you have achieved. I love the concept of 'broken understanding' and the ways in which you have linked this to the literature on e.g. the 'empty choice'. It is a very valuable contribution. Thank you so much for sharing the findings.

Comment by Busisiwe Nkosi on April 23, 2020 at 19:54

Dear Yen,

Congratulations, the study has potential to improve consent process in clinical trials in OUCRU. Are you planning to do any additional/follow up work on this?

Best wishes

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