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 info@globalhealthbioethics.org.

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

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

Many of the scandals that surround modern medicine involve research conducted on human subjects. Consequently when discussion turns to the ethics of research, such atrocities as the Nazi hypothermia experiments at Dachau conentration camp during World War Two (Berger 1990) or the Tuskegee Syphilis Study in Alabama beginning in the 1930s (Pence 2000) are never far from the surface...The reaction to these atrocities has, justifiably, been extreme. In this paper, Sheehan considers the consequences of these reactions - the exclusion of particular groups from participation in research.

21st June 2011 • comment