Dina Bogecho on 9 Feb 2012
A report of the Nuffield Council on Bioethics’ 20th anniversary symposium ‘Global health: responsibility, ethics and policy’ has been published.
Download the report, a video showing highlights of the symposium, the programme, and speaker slides at: www.nuffieldbioethics.org/international/international-global-health-symposium
The Editorial Team on 14 Feb 2012
This site is primarily led by Charles Weijer at UWO.
Anant Bhan on 10 May 2012
Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage. Over the last few years, there has been continuing outrage on the issue of rising outsourcing of clinical trials to India, with concerns about little benefit or relevance to the public health needs of the country. While this dust has not even settled, allegations of unethical conduct in clinical trials have again brought a focus on the need for regulatory reform and stringent ethical safeguards.
India, as an emerging economy needs to continue to promote a strong culture of research and development, including in the health sector. However, attention needs to be paid to ensuring that stringent quality checks are built in, and that investigators conduct research in an impeccable manner. Failure to do so will dent the credibility of the research enterprise, affecting not just investigators or institutions conducting research, but also those planning to do so.
Re-Envisioning Member Checking and Communicating Results as Accountability Practice in Qualitative Research: A South African Community-Based Organization Exampleby Thirusha Naidu (University of KwaZulu-Natal), Neil Prose (Duke University)
Gendered negotiations for research participation in community-based studies: implications for health research policy and practiceby DM Kamuya, CS Molyneux, S Theobald
Enhancing quality and integrity in biomedical research in Africa: an international call for greater focus, investment and standardisation in capacity strengthening for frontline staffby Francis Kombe et al.
Experiencing everyday ethics in context: frontline data collectors perspectives and practices of bioethicsby Patricia Kingori et al.
Community Members Employed on Research Projects Face Crucial, Often Under-Recognized, Ethical Dilemmasby Sassy Molyneux et al.
Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopiaby Henok Negussie, Thomas Addissie, Adamu Addissie, Gail Davey
This study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts.
The practicality and sustainability of a community advisory board at a large medical research unit on the Thai-Myanmar borderby Khin Maung Lwin, Thomas J Peto, Nicholas J White, Nicholas P.J. Day, Francois Nosten, mparker, phaikyeong
Community engagement is increasingly promoted to strengthen the ethics of medical research in low-income countries. One strategy is to use community advisory boards (CABs): semi-independent groups that can potentially safeguard the rights of study participants and help improve research. However, there is little published on the experience of operating and sustaining CABs.
“…..Noncommunicable diseases pose an increasingly high burden of disease that threatens economic and social development, yet cost-effective health interventions exist."
These 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.
Genome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS are taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.
This is a bibliography of articles on the topic of the theory and methodology of empirical ethics. This bibliography was last updated in June 2009, but is nonetheless included here as a potentially useful resource. We would like to keep this bibliography updated. Please let us know if we are missing any references - especially from the last two years.
This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview
Clinical trial governance encompasses sponsorship, contracts, finance, confidentiality, trial insurance and professional indemnity and scientific and ethical review. You can find guidance and template documents relating to all of these topics throughout GlobalHealthTrials.org or you can contribute your own material to help others.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.
Clinical trial regulations can be confusing and unwieldy to researchers. The intention of this section is to explain what regulations exist, where they apply and how to work through them in a sensible and pragmatic way to determine what is applicable to any given trial.