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Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

The art of explaining the consent form to patients?

Hello everyone, it's me Phuong from Vietnam group. I hope that everyone is doing well with your projects. I would like to update some news from my site..

 

Firstly, I want to clarify some changes toward my project. As you know, my original aim was to evaluate the cost effectiveness of different health interventions in  treating patients with HIV and dengue at Hospital of Tropical disease in Ho Chi Minh city. However, after few months I decided to narrow down my project to investigate only the patients with HIV.

 My project now will look at and compare the effectiveness of routine treatment versus new treatment, in treating patients who are at acute phase of HIV and get penicilliosis. My project is part of the large project  which is running at the Oxford university clinical research unit (OUCRU) in Vietnam.

 The project is implemented in 5 hospital sites in Vietnam ranging from North to South. I am based in Hospital for Tropical Diseases in Ho Chi Minh city, and so far I have interviewed 18 HIV patients from this Hospital and have obtained their hospitalized expenses, their answers for cost survey and EQ 5D survey. Because of the interview with the patients I gained some of experiences and went back to reformat the questionnaire. The Project was subsequently altered to incorporate the EQ 5D to measure the patient’s quality of life.

 The progress of project is quite in line with my original expectations .   However, the project took up quite a lot of time in waiting for permission from Ministry of Health. Furthermore, we also encountered some problems when taking the consent form from the patients.  I found it hard when I tried to explain clearly what the research about. For example if we said to the patient that we are going to randomise the patients into 2 group which received different interventions. We almost received the answer " no"  and patient felt that they are being experimented.  Therefore, it's even more difficult if we advance further and explain clearly the risk factors or the benefits of the trial..

Furthermore patient really watched out the word “ research.”  As a matter of fact. we might have to begin the conversation like " this is the program which provide free treatment and is sponsorred by the foreign organisation". however it really twisted the the value of consent form.

I have also managed to collect their cost and quality of life when they are hospitalised.  Normally patients are happy to share their information about cost and their perceptions toward their current health but there is one patient who refused to let the nurse take blood as he felt that taking his blood every day affect his quality of life. Therefore, we opt to his decision and accept some missing values eventhough he has agreed to join the research initially.

My question that I hope could get your advice is how to explain the consent form toward the patients that make them feel that they want to join??

Merry christmas and Happy new year, everyone!

Best,

Phuong

Views: 46

Comment by Dina Rippon on December 20, 2012 at 9:48

Dear Phuong,

Thank you so much for this update. It's so interesting to read about your recent activities, and hear about patient reactions. It's interesting that the word 'research' may be so off-putting to people you're trying to recruit. I guess the fear of being 'experimented' on is understandable, but I see how this can make recruitment difficult. I think you pose a great question and would love to hear from others who've carried out empirical research about how they explained consent forms and research to study populations.

Comment by Michael Parker on February 3, 2013 at 17:55

Thanks Phuong. This is really interesting. It sounds like a bit of a dilemma. Ideally for good ethical practice you want to use the accurate words to describe what you are planning - to obtain consent that is valid - but when you use the word 'research' participants get very worried and assume the project is much more risky than it is. So you are having to choose between consent that is valid in terms of information but invalid in terms of anxiety or consent which is valid in terms of anxiety but invalid in terms of information. Interesting,

It sounds from your description like you are aiming to get consent for both the medical research and for the health economics research at the same time. Am I right about that? Is the worry that the participants are somehow associating the blood sample with your health economics project? Is there any possibility that you could separate out the two consents?

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