11th November 2016 • comment

This study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts.

23rd March 2016 • comment

Field trials of interventions against disease in low and middle income countries (LMICs) may be complex and expensive undertakings. This 3rd edition of the Field Trials Toolbox has been compiled by over 30 contributors with extensive direct experience in the design, conduct, and analysis of field trials in LMICs, and it attempts to document their accumulated experience for the guidance of those who might undertake field trials of health interventions. It can be read in its entirety as an introduction to the field and/or can serve as a reference volume during each of the different stages of planning, conducting, and analysing a field trial.

13th July 2015 • comment

We share a brief on the MCL shared at at the Women Deliver Conference 2013.

4th June 2013 • comment

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.

3rd April 2013 • comment

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.

1st January 2013 • comment

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 Sewankambo

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.

6th September 2012 • comment

This article is an introduction to cluster randomised trials.

23rd July 2012 • comment
19th July 2012 • comment

A Comparison of Online versus On-site Training in Health Research Methodology: A Randomized Study

by Rakesh Aggarwal, Nikhil Gupte, Nancy Kass, Holly Taylor, Joseph Ali, Anant Bhan, Amita Aggarwal, Stephen D Sisson, Sukon Kanchanaraksa, Jane McKenzie-White, John McGready, Paolo Miotti, Robert C Bollinger

Abstract   Background: Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses.Methods: Subjects: Volunteer Indian scientists were randomly assigned to one of two arms. Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical.Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion,compared to baseline. Results: Baseline characteristics were similar in both arms (n = 29 each). Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p < 0.001) 3 months after the on-site course, and from 48% to 63%(p = 0.009) after the on-line course. For the on-site Research Ethics course, median score increased from 69% to 83% (p = 0.005), and for the on-line Research Ethics course from 62% to 80% (p < 0.001). Three months after the course, median gains in knowledge scores remained similar for the on-site and on-line platforms for both Biostatistics (16% vs. 12%; p = 0.59) and Research Ethics (17% vs. 13%; p = 0.14).Conclusion: On-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.

19th July 2011 • comment

Ethics in global health research

by M. Parker, S. Bull

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.

11th February 2011 • comment