This article is an introduction to cluster randomised trials.
Towards a more pragmatic approach to trial regulation
by The EditorsThe border between Thailand and Burma (Myanmar) is at the forefront of the global battle against malaria, and is an important site for research.
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.
Health Researchers’ Ancillary Care Obligations in Low-Resource Settings: How Can We Tell What Is Morally Required?
by Maria W. MerrittHealth researchers working in low-resource settings often encounter serious unmet health needs among participants. What is the nature and extent of researchers’ obligations to respond to such needs? Competing accounts have been proposed, but there is no independent standard by which to assess them or to guide future inquiry. I propose an independent standard and demonstrate its use.
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.
Aligning Community Engagement With Traditional Authority Structures in Global Health Research: A Case Study From Northern Ghana
by Paulina O. Tindana, Linda Rozmovits, Renaud F. Boulanger, Sunita V. S. Bandewar, Raymond A. Aborigo, Abraham V. O. Hodgson, Pamela Kolopack, James V. LaveryStandards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
by EditorsThis article explains the process of data management operations within clinical trials from start to finish.
2010 WHO Technical Report Series on the control of the leishmaniases.
Report from the sixth EDCTP forum in Ethiopia - Clinical trials in practice: how to achieve the best protection of the study subjects?
by Raffaella RavinettoThe report from the Satellite Event at the Sixth EDCTP1 Forum, Addis Ababa, Ethiopia United Nations Conference Centre, 11th October 2011: Clinical trials in practice: how to achieve the best protection of the study subjects?
Article and slide sets about Global Health Trials, which can be used by anyone who may be interested in running seminars in their local institutions, or even organising workshops to further expand on the concept of sharing methods and knowledge to support clinical trials across disease areas.
This editorial describes the work of the WOMAN trial about post partum bleeding, and invites the participation of obstetricians, midwives and nurses from around the world to join an international collaborative effort to identify safe and effective treatments for post partum haemorrhage.
The Critical Path to TB Drug Regimens (CPTR) Initiative is seeking new trial sites for collaboration in planned phase I and II trials. Also available in French - click on the link and scroll down for French version.
The Draft Statement/Guidelines for Disaster Research
by Arthula Sumathipala, Aamir Jafarey, Leonardo de Castro, Aasim Ahmad, Darryl Marcer, Sandya Srinivasan, Nandini K. Kumar, Slemen Sutaryo, Anant Bhan, Dananyaja Wadeyaratne, Sriyakanthi Beneragama, Chandrani Jayasekera, Sarath Edirisingha, Chesmal Siriwardhana, Sisira SiribaddanaThese guidelines were developed following a Working Group on Disaster Research and Ethics (WGDRE) meeting in 2007 with the aim of developing ethical guidelines which would be applicable to post-disaster research, partiuclarly that performed in the developing world. We welcome any feedback from members.
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.
We present this clinical trial as a gold standard example. This study addressed a key question in the management of severely ill children. It was conducted to a very high standard across 3 African countries. This article links to a short film that explains how this trial can be an example to all researchers in resource-limited settings and shows that research can and should be done.
Templates from an investigator-led trial in Cameroon: the CAMPS trial (also available in French)
by Lawrence MbuagbawDuring the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.