Engagement with Human Infection Studies: Panel Discussion at 2018 Wellcome International Engagement Workshopby Noni Mumba, Amrita Sekhar, Mary Chambers, Mesh Editorial Team
Webinar: Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response, 5 March 2019by The Editorial Team
Several of Global Health Trials' Regional Faculties have implemented exceptional, cost-effective blended learning schemes, using a computer room and the Global Health Network's free eLearning courses to create a novel way of building their research teams' skills and knowledge. The Nigerian faculty explain their experiences here, and you can download their "how to" document on the right hand side of the screen, to use at your own site!
Development of an online resource for recruitment research in clinical trials to organise and map current literatureby Anna Kearney, Nicola Harman, Anna Rosala-Hallas, Claire Beecher, Jane Blazeby, Peter Bower, Mike Clarke, William Cragg, Sinead Dune, Heidi Gardner, Patricia Healy, Lisa Maguire, Nicola Mills, Leila Rooshenas, Ceri Rowlands, Shaun Treweek, Akke Vellinga, Paula Williamson, Carrol Gamble
Transparency in the conduct and reporting of clinical trials is supported by the guidance produced on the content of clinical trial protocols and reporting standards for clinical trials. While the principle features of the statistical analysis are required within this guidance it is generally accepted that a separate Statistical Analysis Plan is also developed as the level of detail appropriate for a SAP is excessive for a protocol. However, there is no detailed guidance on the content of a SAP and consequently, there is marked variation in practice.
Summary of two-day international workshop on new challenges in research ethics in Lima, Peru, August 2018by REDe
Abstract Importance While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility. Objective To develop recommendations for a minimum set of items that should be addressed in SAPs for clinical trials, developed with input from statisticians, previous guideline authors, journal editors, regulators, and funders.
Banks, S. et al (2014). Using co-inquiry to study co-inquiry: community-university perspectives on research collaboration. Journal of Community Engagement and Scholarship 7(1).
Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.
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).
Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.
Please see this Sky News interview where we were asked by Sky News to comment on the announcement about this bold vision to tackle all diseases.
Launch of Mesh: a new online platform co-created by its users and aiming to improve Community Engagementby The Editorial Team
Today,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.
How the war in Syria is decimating human resources for health and health systems.
This paper proposes an ethical framework for Community Engagement. The framework is grounded in the insight that relationships between the researcher and the community extend beyond the normal bounds of the researcher-research participant encounter and are the foundation of meaningful engagement.
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.
Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
Strategies for expanding access to quality malaria diagnosis in south-central Asia where malaria incidence is lowby ACTConsortium
Scientific title: An examination of ACT strategy in south-central Asia on P. falciparum malaria in a context where P. vivax is the major species. With the exception of Sub-Saharan Africa, most areas that are endemic for malaria have a combination of two species: Plasmodium falciparum and P. vivax. P. vivax is often the dominant species, accounting for a greater proportion of malaria cases.
The SWAT and SWAR programme is identifying issues about the methods of trials and systematic reviews about which there is sufficient uncertainty to justify research to support well-informed decision making about future designs and choices.
New guidelines help researchers undertaking systematic reviews and IPD meta-analyses to report their findings in a full and transparent manner.
Consulting research stakeholders in Kenya on fair practice in research data sharing: Findings and Policy Implications - Dr Vicki Marsh
Dr Nat Segaren - Medical Director of the Caris Foundation, presents on 'The Haiti National Early Infant Diagnosis of HIV Program'
Notes on How to Survive a GCP Audit forum discussion based on the GCP Inspection Course (Global Health Network eLearning course)by A. Nair, C. Ovenstone, B. Wright, E. Allen, C. Reddy
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.
Ebola PPE guidelines - urgent need to revise WHO and CDC guidelines. This video shows an excerpt from keynote address 'The fuss about face masks', Professor Raina MacIntyre from the School of Public Health and Community Medicine, UNSW Australia.
On the 8th of July 2014 The Global Health Network launched the Global Health Research Process Map, the first digital toolkit designed to enable researchers anywhere in the world to conduct rigorous global health research.
Seven principles for strengthening research capacity in low- and middle-income countries: simple ideas in a complex worldby ESSENCE on Health Research Initiative
This good practice document of the ESSENCE on Health Research initiative is designed to provide broad guidance on how best to strengthen research capacity with the maximum possible benefit.
We 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.
The current difficulties in keeping systematic reviews up to date leads to considerable inaccuracy, hampering the translation of knowledge into action. Incremental advances in conventional review updating are unlikely to lead to substantial improvements in review currency. A new approach is needed. The authors propose living systematic review as a contribution to evidence synthesis that combines currency with rigour to enhance the accuracy and utility of health evidence.
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.
Often, morbidity management in NTDs is overlooked, due to its complexity and expensiveness.
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.
ESSENCE on Health Research have created a good practice document on research costing. It includes a review of the funding practices related to the definition and funding of direct and indirect costs.
This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.
Health data include many gaps, particularly relating to poorer areas of the world, so complex estimation techniques are needed to get overall global pictures. Estimates of population health, however, carry their own uncertainties and may be flawed in some instances. Here we present a range of reflections on the Global Burden of Disease 2010 estimates, highlighting their strengths as well as challenges for potential users. In the long term, there can be no substitute for properly counting and accounting for all the world's citizens, so that complex estimation techniques are not needed.
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, 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.
Repository on maternal child health: Health portal to improve access to information on maternal child health in Indiaby Jai K Das
This article describes a health portal developed in India aimed at providing one-stop access to efficiently search, organize and share maternal child health information relevant from public health perspective in the country.
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.
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.
This article is an introduction to cluster randomised trials.
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 email@example.com.
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."
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.
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, 2011by Consent to and Community Engagement in Health Research Steering Committee
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.
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.
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 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.
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.
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.