These guidance articles are peer reviewed and provided to give research teams high quality and trustworthy information on how to conduct a task or resolve an issue in the design, conduct or reporting of a clinical trial. Articles are accompanied by resources, such as a template or example documents. These are free for you to download and adapt for your study. Please acknowledge www.globalhealthtrials.org if you use these.
This short film shows the impact of the CHAPAS trial on patient health and future possibilities of a small boy from Malawi.
This is a great video of a talk given at the Oxford Martin School by Professor Kevin Marsh.
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.
Join us in Oxford on the 25th of April to mark World Malaria Day 2016 at a series of talks and a panel discussion. The speakers will present their latest projects and help us to understand the unique and interconnected findings of their research.
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.
This glossary provides definitions of some common terms encountered in clinical research.
Recent calls have been made for rapid and responsible sharing of research data in public health emergencies and outbreaks.
Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period.
Could scientists make history and change the way we deal with outbreaks?
Video of Professor Peter Horby, the University of Oxford, on how he and his team set up clinical trials in the heart of the Ebola outbreak.
Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
Investigator initiated pragmatic clinical trials rather than explanatory clinical trials are needed. Collaborative trials should give something back to the community.
In celebration of Global Health Trials' fifth birthday (May 11th 2015) Professor Trudie Lang, Principal Investigator of the programme, talks to us about why Global Health Trials was started, why people should share their experience, and what the future holds.
Strengthening capacity to apply health research evidence in policy making: experience from four countriesby Sarah Hawkes, Bhupinder K Aulakh, Nidhee Jadeja, Michelle Jimenez, Kent Buse, Iqbal Anwar, Sandhya Barge, M. Oladoyin Odubanjo, Abhay Shukla, Abdul Ghaffar, Jimmy Whitworth
Little experience of strengthening the capacity of policy makers in low- and middle- income countries has been published to date. This article describe the experiences of five projects (in Bangladesh, Gambia, India and Nigeria) - author available to comment!
Pragmatic and ethical research in disease outbreak settings: A one-day skills sharing workshop in Ghanaby Abena Konadu Yawson, Dr. Daniel Ansong, Kwaku Poku Asante
Global Health Trials and Kintampo Health Research Centre collaborated to run the workshop 'Pragmatic and ethical research in disease outbreaks' in November 2014. Here we provide a summary of the workshop and the presentations from the day.
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.
The Ebola virus epidemic may well spread out of Africa. Dr Greg Martin takes a look at some of the variables that contribute to this risk and discusses some steps that should be taken.
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.
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.
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.
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.
Health Researchers’ Ancillary Care Obligations in Low-Resource Settings: How Can We Tell What Is Morally Required?by Maria W. Merritt
Health researchers working in low-resource settings often encounter serious unmet health needs among participants. What is the nature and extent of researchers’ obligations to respond to such needs? Competing accounts have been proposed, but there is no independent standard by which to assess them or to guide future inquiry. I propose an independent standard and demonstrate its use.
Physician-researchers’ experiences of the consent process in the socio-cultural context of a developing countryby Aisha Y. Malik
This paper draws on empirical data obtained from interviews with physician-researchers in teaching hospitals of Lahore, Pakistan. The data identify social and cultural factors that affect the consent process for participants in research.
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.
Aligning Community Engagement With Traditional Authority Structures in Global Health Research: A Case Study From Northern Ghanaby Paulina O. Tindana, Linda Rozmovits, Renaud F. Boulanger, Sunita V. S. Bandewar, Raymond A. Aborigo, Abraham V. O. Hodgson, Pamela Kolopack, James V. Lavery
Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participantsby Editors
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.