Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia
by Meseret Molla, Henok Negussie, Moses Ngari, Esther Kivaya, Patricia Njuguna, Fikre Enqueselassie, James A. Berkley, Gail DaveyWe use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials.
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.
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 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.
Sponsorship in non-commercial clinical trials
by Raffaella Ravinetto , Katelijne De Nys, Marleen Boelaert, Ermias Diro, Graeme Meintjes, Yeka Adoke, Harry Tagbor, Minne CasteelsNon-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.
New guidelines help researchers undertaking systematic reviews and IPD meta-analyses to report their findings in a full and transparent manner.
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 countries
by Sarah Hawkes, Bhupinder K Aulakh, Nidhee Jadeja, Michelle Jimenez, Kent Buse, Iqbal Anwar, Sandhya Barge, M. Oladoyin Odubanjo, Abhay Shukla, Abdul Ghaffar, Jimmy WhitworthLittle 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!
Database of References for Intellectual Property Rights and Ethics
by Emma WeisbordIs 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 alThe 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.
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.
Introduction to INTERGROWTH-21st Methodology
by INTERGROWTH-21stZulfiqar Bhutta, Chair of the INTERGROWTH-21st Steering Committee, introduces the rationale for the INTERGROWTH-21st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12032/abstract
Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya (Trials Article)
by Vibian Angwenyi, Dorcas Kamuya - Expert Committee, Dorothy Mwachiro, Betty Kalama, vicki marsh, Patricia Njuguna, Sassy MolyneuxIn this Trials paper, the authors share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya.
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.
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.
Participant retention refers to keeping enrolled participants in a trial for the duration of the study. This article explains the concept of participant retention, and provides a template retention plan.
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.
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
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.
Physician-researchers’ experiences of the consent process in the socio-cultural context of a developing country
by Aisha Y. MalikThis 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.
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.
Report from the sixth EDCTP forum in Ethiopia - Clinical trials in practice: how to achieve the best protection of the study subjects?
by Raffaella RavinettoThe report from the Satellite Event at the Sixth EDCTP1 Forum, Addis Ababa, Ethiopia United Nations Conference Centre, 11th October 2011: Clinical trials in practice: how to achieve the best protection of the study subjects?
The Draft Statement/Guidelines for Disaster Research
by Arthula Sumathipala, Aamir Jafarey, Leonardo de Castro, Aasim Ahmad, Darryl Marcer, Sandya Srinivasan, Nandini K. Kumar, Slemen Sutaryo, Anant Bhan, Dananyaja Wadeyaratne, Sriyakanthi Beneragama, Chandrani Jayasekera, Sarath Edirisingha, Chesmal Siriwardhana, Sisira SiribaddanaThese guidelines were developed following a Working Group on Disaster Research and Ethics (WGDRE) meeting in 2007 with the aim of developing ethical guidelines which would be applicable to post-disaster research, partiuclarly that performed in the developing world. We welcome any feedback from members.
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.
It is a recommendation of some IRB/ECs that back translation is included as a necessary step for the translation of some clinical trial documentation, including informed consent documents. This article explains the reasons for back translation, and takes you through how to effectively perform this step, including explaining how to find a suitable translator for the task.
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.
Health research: the challenges related to ethical review and informed consent in developing countries
by Raffaella RavinettoAn article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings
The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.
This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview
What is the definition of clinical trial monitoring? Who can be a monitor? What are the monitor's roles and responsibilities? Read on for some answers.
An overview of different types of clinical trial oversight committees, including steering committees and data safety monitoring committees.
Clinical trial governance encompasses sponsorship, contracts, finance, confidentiality, trial insurance and professional indemnity and scientific and ethical review. You can find guidance and template documents relating to all of these topics throughout GlobalHealthTrials.org or you can contribute your own material to help others.
Reciprocal or in-house monitoring schemes could be an alternative to expensive out-sourcing. Read on to find out more.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.
The effort invested in pre-trial planning and preparation more than pays off in terms of smooth operations, happy staff, happy participants, good recruitment and ultimately high quality data.
Community sensitisation is a fundamental aspect of clinical trial operations anywhere in the world but is of particular relevance in the developing world. Share your experiences with other developing country researchers.
Clinical trial regulations can be confusing and unwieldy to researchers. The intention of this section is to explain what regulations exist, where they apply and how to work through them in a sensible and pragmatic way to determine what is applicable to any given trial.
The informed consent process is fundamental to ensuring that clinical trials are conducted ethically. This article outlines some issues to consider.