Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study

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.

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.

Cluster Randomised Trials: A primer

This article is an introduction to cluster randomised trials.

Ensuring Consent to Research is Voluntary: How Far Do We Need to Go?

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.

Postpartum haemorrhage and the WOMAN Trial

This editorial describes the work of the WOMAN trial about post partum bleeding, and invites the participation of obstetricians, midwives and nurses from around the world to join an international collaborative effort to identify safe and effective treatments for post partum haemorrhage.

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.

Informed Consent Templates

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

A general introduction to Biomedical Research Ethics

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

Safety Reporting

Considerations for pharmacovigilance and safety reporting.

What is a Clinical Trial?

What is the definition of a clinical trial? Is there an international consensus? Read on to find out.

Community Engagement

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.

Informed Consent

The informed consent process is fundamental to ensuring that clinical trials are conducted ethically. This article outlines some issues to consider.