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.

Conducting good, ethical global health research is now more important than ever. Increased global mobility and connectivity mean that in today’s world there is no such thing as ‘local health’. As a collection, these stories offer a flexible resource for training across a variety of contexts, such as medical research organizations, universities, collaborative sites, and NGOs. 

12th November 2017 • comment

This 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. 

23rd November 2016 • comment

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).

17th November 2016 • comment
11th November 2016 • comment

Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.

24th October 2016 • comment

Today,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.

20th September 2016 • comment

Informed consent is vital in clinical research. Achieving adequate comprehension in low literacy settings however is a significant challenge.

26th July 2016 • comment

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.

14th April 2016 • comment

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

23rd March 2016 • comment

Recent calls have been made for rapid and responsible sharing of research data in public health emergencies and outbreaks.

8th February 2016 • comment

Sponsorship in non-commercial clinical trials

by Raffaella Ravinetto , Katelijne De Nys, Marleen Boelaert, Ermias Diro, Graeme Meintjes, Yeka Adoke, Harry Tagbor, Minne Casteels

Non-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.

8th January 2016 • comment

New guidelines help researchers undertaking systematic reviews and IPD meta-analyses to report their findings in a full and transparent manner.

13th July 2015 • comment

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.

8th May 2015 • comment

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 Whitworth

Little 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!

8th May 2015 • comment
21st December 2014 • comment

The 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.

18th August 2014 • comment

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.

2nd June 2014 • comment

Zulfiqar 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

15th May 2014 • comment

Research ethics is strictly interrelated to scientific and methodological standards: a research project involving human participants is never ethical, if it is not scientifically and methodologically sound in the first place.

17th March 2014 • comment

In 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.

13th March 2014 • comment

This article, published in AIDS & Clinical Research, reports on a project aiming at building the capacity of regulatory agencies in Nigeria.

22nd January 2014 • 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

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.

25th March 2013 • comment

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.

12th March 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

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

9th August 2012 • comment

Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage.

25th May 2012 • comment

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.

2nd April 2012 • comment

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.

21st February 2012 • comment

The 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?

29th November 2011 • comment

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 Siribaddana

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.

24th October 2011 • comment

This 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.

1st August 2011 • comment

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.

9th June 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

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

24th January 2011 • comment

The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

5th January 2011 • comment

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

29th November 2010 • comment

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

26th October 2010 • comment

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.

2nd February 2010 • comment

An overview of different types of clinical trial oversight committees, including steering committees and data safety monitoring committees.

21st November 2009 • comment

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.

21st November 2009 • comment

Reciprocal or in-house monitoring schemes could be an alternative to expensive out-sourcing. Read on to find out more.

21st November 2009 • comment

The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.

21st November 2009 • comment

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.

21st November 2009 • comment

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.

21st November 2009 • comment

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.

21st November 2009 • comment

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

21st November 2009 • comment