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Planning, Monitoring and Evaluation Framework for Capacity Strengthening in Health Research - ESSENCE Good Practice

The ESSENCE on Health Research initiative has created a good practice document on Planning, Monitoring and Evaluation Framework for Capacity Strengthening in Health Research.

Five keys to improving research costing in low- and middle-income countries

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. 

Implementation Research in Health: A Practical Guide from the WHO

This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.

Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice

Challenges of non-commercial multi-centre North-South collaborative clinical trials

The last decade has witnessed a substantial increase of multi-centre, public health-oriented clinical trials in poor countries. However, non-commercial research groups have less staff and financial resources than traditional commercial sponsors, so the trial teams have to be creative to comply with Good Clinical Practices (GCP) requirements. This article hopes to feed the reflection on the methodological and ethical aspects of clinical trials carried out in developing countries by North-South collaborative research groups.

Reviewing Clinical Trials: A Guide For The Ethics Committee

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.

Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon

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.

Downloadable Templates and Tools for Clinical Research

A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.

Towards a more pragmatic approach to trial regulation

Research and Development to Meet Health Needs in Developing Countries

The evolving threat of antimicrobial resistance- Options for Action

Data Management - an overview

This article explains the process of data management operations within clinical trials from start to finish.

Ethical issues in human genomics research in developing countries

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.

A gold standard example of running a trial in Africa

We present this clinical trial as a gold standard example. This study addressed a key question in the management of severely ill children. It was conducted to a very high standard across 3 African countries. This article links to a short film that explains how this trial can be an example to all researchers in resource-limited settings and shows that research can and should be done.

Templates from an investigator-led trial in Cameroon: the CAMPS trial (also available in French)

During the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.

Setting up a Regional Faculty

Regional faculties provide opportunity for increased professional networking and clinical trial skill sharing at a local level. The Global Health Regional Faculties are being set up to facilitate activities that will increase and support clinical research in specific regions this is achieved by sharing skills, knowledge and experience between disease areas, job roles and research sites. Examples are opening up spaces on training courses or for meetings, supporting exchange or observational site visits. This article explains how interested groups could set up a faculty in their region

Health research: the challenges related to ethical review and informed consent in developing countries

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

Informed Consent Templates

A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.

Reciprocal Monitoring Scheme Guidance

This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.

Guidelines for Clinical Trial Registration

An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.