Strengthening the Informed Consent Process in International Health Research...

Link to online article about improving the informed consent through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experience.
Samson Muchina Kinyanjui and colleagues from the KEMRI-Wellcome Trust Research Programme discuss how they modified their informed consent processes by taking into account local social, cultural, and economic contexts in the design and administration of consent forms.

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Bookmarked by The Editorial Team on 9 Nov 2011

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Update on the successful Consent and Community Engagement workshop held in Kilifi, Kenya in February 2011

By dbogecho

The Workshop on Consent to and Community Engagement in Health Research, Reviewing and Developing Research and Practice, was held in ...

Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study

by Ronald Kiguba, Paul Kutyabami, Stephen Kiwuwa, Elly Katabira, Nelson K Sewankambo

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.

6th September 2012 • comment

This bibliography is a work in progress and is regularly revised. We are currently updating it to link to any listed papers that are available via open access. If there are papers we're missing, or if you have other comments, please let us know by writing to

2nd April 2012 • comment

Abstract Guidance requires that consent processes for research be appropriately tailored to their cultural context. This paper discusses the use of rapid assessments to identify cultural and ethical issues arising when explaining research in studies in The Gambia and Ethiopia.

28th February 2012 • comment

This paper draws on empirical data obtained from interviews with physician-researchers in teaching hospitals of Lahore, Pakistan. The data identify social and cultural factors that affect the consent process for participants in research.

21st February 2012 • comment

One fundamental ethical principle underpinning research ethics is that of respect for persons. It requires that researchers respect research participants’ autonomy, interests, and wishes, and act on the presumption that participants are the best judges of what their interests are (Nuffield Council on Bioethics 2002). This presumption obliges us to design consent processes for research that facilitate prospective participants’ free and informed decisions as to whether or not to participate in a study.

21st February 2012 • comment

Five seed documents are provided here for use in clinical research, which can be adapted and altered for each study. Here we provide a template concept protocol, a study protocol, a CRF, an informed consent form, and a generic SOP.

30th November 2011 • comment

UPDATED: August 2011. This bibliography primarily lists references for papers published on the topic of informed consent (especially as it relates to empirical studies carried out in developing countries), and the topic of community engagement (again, focusing on studies carried out in developing countries). We would like to keep this bibliography comprehensive and updated. Please let us know if we are missing any papers on these topics.

8th August 2011 • comment

This is the Report from the "Consent to and Community Engagement in Health Research" workshop, which took place between 28 Feb - 03 Mar 2011 in Kilifi, Kenya. The workshop built upon an emerging collaboration between the Ethox Centre in Oxford, the Social and Behavioural Research Group at the Wellcome-KEMRI Unit in Kilifi, the Liverpool School of Tropical Medicine and the Mahidol - Oxford Tropical Medicine Research Unit in Thailand.

1st August 2011 • comment

It is a recommendation of some IRB/ECs that back translation is included as a necessary step for the translation of some clinical trial documentation, including informed consent documents. This article explains the reasons for back translation, and takes you through how to effectively perform this step, including explaining how to find a suitable translator for the task.

9th June 2011 • comment

Community sensitisation is a fundamental aspect of clinical trial operations anywhere in the world but is of particular relevance in the developing world. Share your experiences with other developing country researchers.

21st November 2009 • comment