Articles

Cluster Randomised Trials: A primer

This article is an introduction to cluster randomised trials.

Towards a more pragmatic approach to trial regulation

Moral and scientific boundaries: research ethics on the Thai-Burma border

The border between Thailand and Burma (Myanmar) is at the forefront of the global battle against malaria, and is an important site for research.

Clinical trial ethics in India: One step forward, two steps back

Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage.

Improving Ethical Review of Research Involving Incentives for Health Promotion

We argue that some common concerns about using incentives to increase participation in research, such as that attractive incentives will undermine participant autonomy, are misplaced when incentives are used to overcome economic obstacles or a lack of effective motivation, and when recipients are incentivized to engage in health-related behaviors or practices with which they are already familiar and which they regard as beneficial or worthwhile.

Consent and Community Engagement – A Bibliography in Progress

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.

Bioethics in China: The Origins and State of the Field

This is an audio recording of a lecture given by Prof. Charlotte Ikels at Oxford University on 22nd February 2012. Professor Ikels is Professor of Anthropology Emerita at Case Western Reserve University and Lecturer in the Department of Global Health and Social Medicine at Harvard Medical School.

Tailoring Information Provision and Consent Processes to Research Contexts: The Value of Rapid Assessments

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.

Ensuring Consent to Research is Voluntary: How Far Do We Need to Go?

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.

Ethical tensions in dealing with noncommunicable diseases globally

“…..Noncommunicable diseases pose an increasingly high burden of disease that threatens economic and social development, yet cost-effective health interventions exist."

Study documents

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.

Consent and Community Engagement - A Draft Bibliography

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.

The use of race, ethnicity and ancestry in human genetic research

Abstract Post-Human Genome Project progress has enabled a new wave of population genetic research, and intensified controversy over the use of race/ethnicity in this work. At the same time, the development of methods for inferring genetic ancestry offers more empirical means of assigning group labels. Here, we provide a systematic analysis of the use of race/ethnicity and ancestry in current genetic research. We base our analysis on key published recommendations for the use and reporting of race/ethnicity which advise that researchers: explain why the terms/categories were used and how they were measured, carefully define them, and apply them consistently. We studied 170 population genetic research articles from high impact journals, published 2008–2009. A comparative perspective was obtained by aligning study metrics with similar research from articles published 2001–2004. Our analysis indicates a marked improvement in compliance with some of the recommendations/guidelines for the use of race/ethnicity over time, while showing that important shortfalls still remain: no article using ‘race’, ‘ethnicity’ or ‘ancestry’ defined or discussed the meaning of these concepts in context; a third of articles still do not provide a rationale for their use, with those using ‘ancestry’ being the least likely to do so. Further, no article discussed potential socio-ethical implications of the reported research. As such, there remains a clear imperative for highlighting the importance of consistent and comprehensive reporting on human populations to the genetics/genomics community globally, to generate explicit guidelines for the uses of ancestry and genetic ancestry, and importantly, to ensure that guidelines are followed.

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

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.

A Comparison of Online versus On-site Training in Health Research Methodology: A Randomized Study

Abstract   Background: Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses.Methods: Subjects: Volunteer Indian scientists were randomly assigned to one of two arms. Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical.Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion,compared to baseline. Results: Baseline characteristics were similar in both arms (n = 29 each). Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p < 0.001) 3 months after the on-site course, and from 48% to 63%(p = 0.009) after the on-line course. For the on-site Research Ethics course, median score increased from 69% to 83% (p = 0.005), and for the on-line Research Ethics course from 62% to 80% (p < 0.001). Three months after the course, median gains in knowledge scores remained similar for the on-site and on-line platforms for both Biostatistics (16% vs. 12%; p = 0.59) and Research Ethics (17% vs. 13%; p = 0.14).Conclusion: On-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.

Ethical issues in human genomics research in developing countries

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.

Book Review on Climate Change: Addressing the Ethical Dimension

Science 17 June 2011: 1382-1383.[DOI:10.1126/science.1205393]Describing how a convergence of factors has greatly expanded the challenges we face, Moss argues for the crucial importance of ethics in considerations of how to respond to anthropogenic climate change.A Perfect Moral Storm-  The Ethical Tragedy of Climate Changeby Stephen M. GardinerOxford University Press,New York, 2011. 507 pp. $35,£22.50. ISBN 9780195379440.

Vulnerability and Exclusion from Research

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.

Spotlight on Global Health Governance - National and Global Responsibilities for Health

This article is available for free from the Bulletin of the World Health Organization.Lawrence O. Gostin et al., National and Global Responsibilities for Health (Editorial), 88 Bulletin of the World Health Organization 719-20 (October, 2010), available at: http://www.who.int/bulletin/volumes/88/10/10-082636.pdf Preventable and treatable injuries and diseases are overwhelming sub-Saharan Africa, the Indian subcontinent and other impoverished areas of the world. Every year, 8 million children die before they reach the age of 5, more than 300 000 women die in pregnancy or childbirth, and more than 4 million people die of AIDS, malaria, or tuberculosis. By 2005, 80% of deaths from noncommunicable diseases were in developing countries. Healthy life expectancy in Africa is 45 years, a full quarter-century less than in high-income countries.

Spotlight on Global Health Inequality - The unconscionable health gap: a global plan for justice

This article is available online, free of charge from: The Lancet, Volume 375, Issue9725, Pages 1504 - 1505, 1 May 2010   See: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2960065-7/fulltext   Health has special meaning and importance to individuals and communities. WHO's Constitution states that “the enjoyment of the highest attainable standard of health” is a fundamental human right. International law, moreover, requires states to guarantee the right to health. The UN has specified the norms and obligations of the right to health, and appointed a Special Rapporteur.