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.
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.
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, 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.
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 border between Thailand and Burma (Myanmar) is at the forefront of the global battle against malaria, and is an important site for research.
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.
These 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.
Health research: the challenges related to ethical review and informed consent in developing countriesby Raffaella Ravinetto
An 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
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
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.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.
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.