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 SewankamboThe 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.
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.
Physician-researchers’ experiences of the consent process in the socio-cultural context of a developing country
by Aisha Y. MalikThis 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.
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.
Report from Workshop on Consent and Community Engagment in Health Research: Reviewing and Developing Research and Practice, Kilifi, Kenya Monday 28th February – Thursday 3rd March, 2011
by Consent to and Community Engagement in Health Research Steering CommitteeThis 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.
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.
Health research: the challenges related to ethical review and informed consent in developing countries
by Raffaella RavinettoAn article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings
A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.
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.
The informed consent process is fundamental to ensuring that clinical trials are conducted ethically. This article outlines some issues to consider.