Global Health Research in an Unequal World: Ethics Case Studies from Africa
by Gemma Aellah, Tracey Chantler, P. Wenzel GeisslerThis 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.
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).
Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.
Launch of Mesh: a new online platform co-created by its users and aiming to improve Community Engagement
by The Editorial TeamToday,The Global Health Network launches Mesh: a new online platform co-created by its users and aiming to improve Community Engagement with health in low and middle income countries.
Informed consent is vital in clinical research. Achieving adequate comprehension in low literacy settings however is a significant challenge.
Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia
by Henok Negussie, Thomas Addissie, Adamu Addissie, Gail DaveyThis 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.
New guidelines help researchers undertaking systematic reviews and IPD meta-analyses to report their findings in a full and transparent manner.
Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali
by Karim Traore, Susan Bull, Alassane Niare, Salimata Konate, Mahamadou A. Thera, Dominic Kwiatkowski, mparker, Ogobara K. DoumboObtaining 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.
Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand
by Pornpimon Adams et alWe have recently obtained permission to share some very interesting videos on The Global Health Network. The videos are from Global Health Videos by Greg Martin. You can follow more videos from him at his YouTube channel. This series of videos deal with Glolbal Health and Ethics.
Preparing for HIV Vaccine Trials in Nigeria: Building the Capacity of the Community and National Coordinating, Regulatory and Ethical Bodies
by Okpokoro, E, Osawe, S, Datong, P, Yakubu, A, Morenike Ukpong - Senior Contributor, Regional Faculty Committee, Orhii, P, Dakum, P, Garber, G, Abimiku AThis article, published in AIDS & Clinical Research, reports on a project aiming at building the capacity of regulatory agencies in Nigeria.
Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the principle of justice
by Rafael Dal-Ré, Nicholas Katsanis, Sara Katsanis, Lisa S. Parker, Carmen AyusoGenome/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.
Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice
by The Editorial TeamResearch 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 border
by Khin Maung Lwin, Thomas J Peto, Nicholas J White, Nicholas P.J. Day, Francois Nosten, mparker, phaikyeongCommunity 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.
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.
Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon
by Nchangwi S Munung, Godfrey B Tangwa, Chi P Che, Laurent Vidal, Odile Ouwe-Missi-Oukem-BoyerUniversities 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.
Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage.
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.
Tailoring Information Provision and Consent Processes to Research Contexts: The Value of Rapid Assessments
by Susan Bull, Bobbie Farsides, Fasil Tekola AyeleAbstract 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?
by Susan Bull, Graham LindeggerOne 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.
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.
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.
Vulnerability and Exclusion from Research
by Mark P. SheehanMany 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.
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.