Research Involving Health Providers and Managers: Ethical Issues Faced by Researchers Conducting Diverse Health Policy and Systems Research in Kenya.by Sassy Molyneux, Benjamin Tsofa, Edwine Barasa, Mary Muyoka Nyikuri, Evelyn Wanjiku Waweru , Catherine Goodman, Lucy Gilson
The authors examine the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants.
Conducting good, ethical global health research is now more important than ever. Increased global mobility and connectivity mean that in today’s world there is no such thing as ‘local health’. As a collection, these stories offer a flexible resource for training across a variety of contexts, such as medical research organizations, universities, collaborative sites, and NGOs.
This book is a collection of fictionalised case studies of everyday ethical dilemmas and challenges, encountered in the process of conducting global health research in places where the effects of global, political and economic inequality are particularly evident.
It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North–South collaborative trialsby GHN Editors
The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs).
How the war in Syria is decimating human resources for health and health systems.
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.
Recent calls have been made for rapid and responsible sharing of research data in public health emergencies and outbreaks.
Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Maliby Karim Traore, Susan Bull, Alassane Niare, Salimata Konate, Mahamadou A. Thera, Dominic Kwiatkowski, Michael Parker, Ogobara K. Doumbo
Obtaining informed consent for participation in genomic research in low-income settings presents specific ethical issues requiring attention. These include the challenges that arise when providing information about unfamiliar and technical research methods, the implications of complicated infrastructure and data sharing requirements, and the potential consequences of future research with samples and data.
Investigator initiated pragmatic clinical trials rather than explanatory clinical trials are needed. Collaborative trials should give something back to the community.
Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailandby Pornpimon Adams et al
Professor Peter Piot, LSHTM, talks about Ebola and implications for Africa and understanding future epidemics at the Martin School, University of Oxford, 16th October 2014.
Preparing for HIV Vaccine Trials in Nigeria: Building the Capacity of the Community and National Coordinating, Regulatory and Ethical Bodiesby Okpokoro, E, Osawe, S, Datong, P, Yakubu, A, Morenike Ukpong - Senior Contributor, Regional Faculty Committee, Orhii, P, Dakum, P, Garber, G, Abimiku A
This article, published in AIDS & Clinical Research, reports on a project aiming at building the capacity of regulatory agencies in Nigeria.
Genome/exome data are likely to play an increasing role in clinical trials, and incidental findings are likely to be viewed as potential benefits for individuals of research participation.
Research misconduct is a global problem as research is a global activity. Wherever there is human activity there is misconduct, but we lack reliable data on the extent and distribution of research misconduct. This PLoS paper seeks to illustrate some examples of researsch misconduct in LMICs.
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, Michael Parker, Phaik Yeong Cheah
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.
This guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.
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.
Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist's potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics.
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 trials in India continue to be in the news, unfortunately a fair bit being negative coverage.
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.
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 firstname.lastname@example.org.
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 Assessmentsby Susan Bull, Bobbie Farsides, Fasil Tekola Ayele
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.
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.
“…..Noncommunicable diseases pose an increasingly high burden of disease that threatens economic and social development, yet cost-effective health interventions exist."
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.
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.
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.
This articles explores some of the ethical issues arising in the context of collaborative global health research networks involving partners in developing and developed countries.