e-MOPs

Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

Hello everyone,

I hope you are doing well after the Global Health Bioethics Summer School. The workshop was great and unforgettable.

I would like to start a discussion on how the Informed consent project should be done in Vietnam and would like to get your experience and materials. Does any one did the similar project before or currently on the progress? Any piece of papers/materials/advices is much appreciate!

Thanks and have a nice weekend!

Thuy

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Hi Thuy

Thanks for this. Please let us know what your primary research question is - why are you conducting this study?

In the meantime, here are some resources that might be useful and our colleagues from Kilifi can no doubt suggest more from their own work.

A couple of recent papers that I've been involved in that might be useful are listed below - please let me know if you have difficulty getting hold of them and I'll email them through.

Seeking consent to genomic research in a rural Ghanaian African set...
Tindana, P, Bull, S, Amengo-Etego, L, de Vries, J, Aborigo, R, Koram, K, Kwiatkowski, D, and Parker, M
(2012) BMC Medical Ethics, 13(15).
Tailoring information provision and consent processes to research c...
Bull, S, Farsides, B, and Tekola, F
 (2012) J Empir Res Hum Res Ethics, 7(1):37-52.
We also have a bibliography of empirical research on consent (and commuity engagement) which is available at http://globalhealthbioethics.tghn.org/articles/consent-and-communit...
This can provide some useful insights into types of studies people are conducting on consent to research and the methods they are using to do so.
Finally, Phaik Yeong and I are developing a protocol for studying consent to Malaria research in Bangladesh and we'll check if our co-researchers are happy for us to make this available to you.
I hope this is a useful start
Bw Susi

Dear Susan,

Thanks for sending me the useful papers and update on the protocol development from Thai MOP and look forward to receive the protocol details.

I would like to answer to your questions related to our project: we planed to create a policy or an useful guidance for EC/IRBs or researchers on informed consent for non-RCT studies; they can use it as a suggested template or write a SOPs. Data will be pooled from EC/IRBs members and/or MoH (Ministry of Health representative) and/or patients through interviews depending on the time and budget limits. And the research question: "What is essential information should be included in informed consent form for clinical research (non-RCT) according to opinions of researchers and IRB’s members/ (MoH's/patients)?"

I m waiting for further discussion or comment on this.


Best,

Thuy

P/S: I could not get  the 2nd paper  "Tailoring information provision and consent processes to research c....." ; the 1st one I can be able to obtain it by google. Could you please email it to me? Thx

Dear Thuy

Thanks for reminding me of your research question - the protocol we'll be using for the Malaria Study could easily be adapted to answer that question. I think Phaik Yeong might email it to you directly and I'll see about posting it here as well.

I will email you the second paper - thanks for letting me know you couldn't get it - we did pay for it to be open access so I will chase that up!


If you want to take our Malaria protocol and put together a draft for your own study I'd be very happy to comment on it and I'm sure others on the eMOP site would be as well.


Best wishes

Susan

Dear Susi,

I got the paper! Actually I expected to receive them directly when I click to the link that you sent me. But I just received one by google, so maybe you want to check on the other too if you did pay for it.

It's nice of having you and Phaik Yeong are working on the similar thing; it can save resources and we can draft a protocol base on something does exist. Your comment on it is much appreciate and I m looking for that. Another resources that I m waiting for is from Kilifi group as I heard I did something similar: I would like to learn from the initiation, process and results.

Thanks,
Thuy



Nguyen Thi Thanh Thuy said:

Dear Susi,

I got the paper! Actually I expected to receive them directly when I click to the link that you sent me. But I just received one by google, so maybe you want to check on the other too if you did pay for it.

It's nice of having you and Phaik Yeong are working on the similar thing; it can save resources and we can draft a protocol base on something does exist. Your comment on it is much appreciate and I m looking for that. Another resources that I m waiting for is from Kilifi group as I heard I did something similar: I would like to learn from the initiation, process and results.

Thanks,
Thuy



Vicki Marsh said:

Dear Thuy

We have done quite a lot of work on informed consent in Kilifi, particularly in trying to strengthen processes given - as you say - the sometimes quite long formats that are around. We have a local committee, called the Consent and Communication Committee, in the research programme which has representatives from many different departments (wards, labs, community etc). This committee routinely reviews all information and consent forms/processes for new proposals and makes recommendations on how to strengthen, including looking at the process used as well as the forms. I'm emphasizing the process because we found that the way that the consent process is undertaken is at least as important as the form. The process includes, for example, how the people who will undertake informed consent are trained and monitored, and what extra information - not central to study but essential to people understanding of the study (e.g. about the disease being studied, or the difference between treatment and research) - should be included as part of the communication process.

We based the process and forms we use as guidance in Kilifi on two kinds of inputs: i) looking at the requirements from relevant guidelines e.g. the Kenya National Council for Science & Technology, CIOMS and GCP and ii) taking into account local social science research on people's understanding/concerns about research. We've been using these for a few years now, and periodically we update them.

The 'forms' we've developed are templates that researchers use to guide the development of their own materials. These are i) an 'SOP' template to describe the process for informed consent in a study and ii) 5 different informed consent templates, which cover 5 different types of research. These are: clinical trials; studies involving sample taking only (facility-based); studies involving sample taking only (household based); ward-based observations only; and interviews only. This probably seems a lot of templates but the selection was based on the types of study that the committee were regularly seeing and where different types of information/emphasis were needed. All of the ICF templates are available on a href="http://globalhealthtrials.tghn.org/articles/informed-consent-templates/>" target="_blank">http://globalhealthtrials.tghn.org/articles/informed-consent-templa...; and I'm also sending you the SOP template that we are currently working with.

We also published a short report on this process in PLoS Medicine, which I will try to send you but you could also get directly from PLoS Medicine website:

Boga M, Davies A, Kamuya D.M, Kinyanjui S.M,  Kivaya E, Kombe F.K, Lang T, Marsh V, Mbete B, Mlamba A,  Molyneux C.S,  Mulupi  S and Mwalukore S (Consent and Communication Committee, KEMRI Wellcome Trust Research Programme, Kilifi) (2011) Strengthening the Informed Consent Process in International Health Research through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experience. PLos Medicine, 8 (9) e1001089

Good luck with this and let us know if we can help more,

Vicki

Nguyen Thi Thanh Thuy said:

Dear Susi,

I got the paper! Actually I expected to receive them directly when I click to the link that you sent me. But I just received one by google, so maybe you want to check on the other too if you did pay for it.

It's nice of having you and Phaik Yeong are working on the similar thing; it can save resources and we can draft a protocol base on something does exist. Your comment on it is much appreciate and I m looking for that. Another resources that I m waiting for is from Kilifi group as I heard I did something similar: I would like to learn from the initiation, process and results.

Thanks,
Thuy

Hi Thuy. It is nice to hear from you. I think your idea of trying to develop a model of good practice for informed consent forms in Vietnam is a great idea. I once did some work on this issue as part of the MalariaGEN project. This was an international project rather than a national initiative but I expect it raised some of the same issues. One thing that came up in discussion a lot was how best to develop an approach to consent forms which was sensitive to the variation between contexts and also recognised the importance of agreed high standards of consent across the project as a whole. I suppose the equivalent question for your project might be, how can we make sure that consent forms across the country are of a high standard whilst at the same time allowing researchers and research ethics committees to take account of the differences between research projects and settings. After much discussion across the MalariaGEN network we adopted a solution which was as follows. Through discussion we developed a consent 'template' which contained all of the key elements that every consent form must include in every setting. This was agreed through a series of meetings and consultations. The was this was used in practice was that each project site developed their own consent form in the light of local contextual factors but each of these forms had to be built upon the shared template. Perhaps your project could do something similar i.e. get some agreement at the national level about the key essential elements of the informed consent process and agreement about which elements could be  modified or developed by local RECs or researchers. In case you are interested I am attaching a copy of a paper we wrote on this - a long time ago.

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