Global Code of Conduct for Research in Resource-Poor Settings​

Learning Materials

Existing guidelines

Existing guidelines have played an important role in formulating the code. While we are not quoting any article directly, we have taken substantial inspiration from the ethics guidelines listed below:

Canadian Coalition for Global Health Research: Principles for Global Health Research. Available at CCGHR Principles for Global Health Research

CIOMS and WHO: International Ethical Guidelines for Health-related Research Involving Humans. Available at CIOMS 2016

Convention on Biodiversity: Nagoya Protocol. Available at Nagoya Protocol 2014

Council on Health Research for Development: Research Fairness Initiative. Available at COHRED RFI

European Code of Conduct for Research Integrity. Available at

GlaxoSmithKline: Clinical Trials in the Developing World. Available at GSK Public Policy Statement 2014

Indian Council of Medical Research: National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. Available at ICMR 2017

International Society of Ethnobiology: ISE Code of Ethics. Available at ISE 2006

Research Councils UK: RCUK Common Principles on Data Policy. Available at RCUK Common Principles on Data Policy 2011

Roche: Animal Research − Roche Principles of Care and Use. Available at Roche Animal Care 2013

Sanofi: Corporate Social Responsibility Factsheet on Biodiversity and Biopiracy. Available at Sanofi Biodiversity and Biopiracy 2013

South African Medical Research Council. Use of Animals in Research and Training. Available at SA MRC Ethics Booklet 2004

South African San Institute, South African San Council and TRUST project: San Code of Research Ethics. Available at San Code of Research Ethics 2017

Swiss Academy of Sciences, Commission for Research Partnerships with Developing Countries: 11 Principles & 7 Questions. KFPE’s Guide for Transboundary Research Partnerships. Available at 11 principles & 7 questions

3rd World Conference on Research Integrity: Montreal Statement on Research Integrity in Cross-boundary Research Collaborations. Available at Montreal Statement 2013

UNESCO: Universal Declaration on Bioethics and Human Rights 2005. Available at UDBHR

World Medical Association: Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Available at Declaration of Helsinki 2013

Case Studies

D. Schroeder, J. Cook, F. Hirsch, S. Fenet, V. Muthuswamy (eds.). 2018. Ethics Dumping. Case Studies from North-South Research Collaborations, Springer Briefs in Research and Innovation Governance. Available at Springer Link

Ethics Dumping: Introduction

Abstract Achieving equity in international research is a pressing concern. Exploitation in any scenario, whether of human research participants, institutions, local communities, animals or the environment, raises the overarching question of how to avoid such exploitation. Agreed principles can be universally applied to research in any discipline or geographical area, whatever methodologies are employed. This chapter introduces a collection of case studies, presenting a range of up-to-date examples of exploitation in North-South research collaborations, in order to raise awareness of ethics dumping. [PDF

Social Science Research in a Humanitarian Emergency Context  

Abstract This case study about research in an emergency setting depicts how unexpected findings created conflicts of conscience for non-governmental organi- zation (NGO) workers and exposed research participants and their community to retribution and compromised the local social structure. The community felt betrayed when unexpected findings from research about health seeking behaviours revealing illegal female genital mutilation were shared publicly and contributed to stigma- tizing their culture. In addition, the NGO involved performed a dual role – that of assistance provider as well as researcher – which endangered the neutrality of the data collection and, in the end, the acceptability of the NGO as assistance provider. [PDF]

International Genomics Research Involving the San People

Abstract In 2010 an international genomic research project entitled “Complete Khoisan and Bantu genomes from southern Africa” was published in Nature amidst wide publicity (Schuster et al 2010). The research aimed to examine the genetic structure of “indigenous hunter-gatherer peoples” selected from Namibia, and to compare the results with “Bantu from southern Africa” , including Nobel peace prize winner Archbishop Desmond Tutu. Four San individuals, the eldest in their respective communities, were chosen for genome sequencing, and the pub- lished article analysed many aspects of the correlations, differences and relation- ships found in the single-nucleotide polymorphisms (SNPs) (A single-nucleotide polymorphism is a variation in a single nucleotide that occurs at a specific position in a genome, where each variation is present to some appreciable degree within a population) within the sequenced genomes. … [PDF]

Sex Workers Involved in HIV/AIDS Research

Abstract This case study is written as a personal story by an outside support worker starting to engage with sex workers, a vulnerable and stigmatized population in a Nairobi slum. We hope the shared experiences will give better insight into the difficulties faced by members of this key population as they eke out a living. It is also a positive case study, not one of exploitation, despite sex work being illegal in Kenya. [PDF]

Cervical Cancer Screening in India

Abstract Three clinical trials took place in India between 1998 and 2015 in urban and rural areas of Mumbai, Osmanabad and Dindigul. The trials aimed to determine whether trained health care workers could conduct cervical cancer screening in a community using cheap methods of testing – primarily visual inspection with acetic acid – to reduce the incidence and mortality rate of cervical cancer. The clinical trials were conducted on approximately 374,000 women, of whom about 141,000 were placed in the control arm (no screening). Although the standard of care for testing of the disease in India has been cytology screening (or Pap smear) since the 1970s, screening for cervical cancer was not available universally under a government programme, and for the study purposes the standard of care was therefore misconstrued to be no screening. … [PDF]

Ebola Vaccine Trials

Abstract The Ebola epidemic that broke out in West Africa towards the end of 2013 had been brought under reasonable control by 2015. The epidemic had severely affected three countries. This case study is about a phase I/II clinical trial (testing for safety and immunogenicity) of a candidate Ebola virus vaccine in 2015 in a sub-Saharan African country which had not registered any cases of the Ebola virus disease. The study was designed as a randomized double-blinded trial. It was sponsored and funded by one of the biggest Northern multinational pharmaceutical companies. The protocol received ethics clearance from the relevant national ethics committee. The study was coordinated and managed at the local branch of a big Northern diagnostic laboratory and a laboratory of a local regional hospital. … [PDF]

Hepatitis B Study with Gender Inequities

Abstract This case study is about a study entitled “Comparable randomized double-blind investigation of safety and immunogenicity of vaccine against Hepatitis B in healthy adult subjects” proposed in Russia with an international sponsor. There were indications of elements of exploitation, which consisted of inadequacies in the study’s design compared with its announced purpose, and the indirect inclusion of women research subjects in the clinical trial without their in- formed consent. On the basis of noncompliance with the applicable regulatory and ethical requirements the study was not approved by the local ethics committee (LEC). [PDF]

Healthy Volunteers in Clinical Studies

Abstract Patients participate in clinical trials for a variety of reasons, the first of which is often the prospect of direct health benefits for themselves. Healthy vol- unteers, by definition, cannot expect such benefits. In resource-limited settings, healthy volunteers are most often poor people with low literacy levels who might not understand the risks they may be taking and are in no position to refuse financial incentives. For many of them, participation in clinical trials is a critical source of income. An added complication is that some participants covertly enrol in several studies simultaneously, in order to increase their income. This exposes the volunteers to medical risks (e.g. drug-drug interactions), and also potentially biases study data. … [PDF]

An International Collaborative Genetic Research Project Conducted in China

Abstract In 1995, a research team from a renowned US university started col- lecting blood samples from villagers living in Anhui province, China, with the cooperation of local research institutes and the Chinese government. In 2000, the US university team was accused of violating research ethics principles by not adequately informing the participants about the research and not sharing benefits fairly. Subsequent investigations by American and Chinese media and authorities showed that the US research institute, its research personnel and a pharmaceutical company involved were benefiting substantially from the project, while the Chinese research participants and the government were not. Three levels of exploitation can be distinguished in this case … [PDF]

The Use of Non-human Primates in Research

Abstract The use of non-human primates in biomedical research is a contentious issue that raises serious ethical and practical concerns. In the European Union, where regulations on their use are very tight, the number of non-human primates used in research has been in decline over the past decade. However, this decline has been paralleled by an increase in numbers used elsewhere in the world, with less regard for some of the ethical issues (e.g. genetic manipulations). There is evidence that researchers from high-income countries (HICs), where regulations on the use of non-human primates are strict, may be tempted to conduct some of their experi- ments in countries where regulation is less strict, through new collaborative efforts. In collaborative ventures, equivalence in the application of ethical standards in animal research, regardless of location, is necessary to avoid this exploitation. [PDF]

Human Food Trial of a Transgenic Fruit

Abstract The research and development of any “new” agricultural crop created using genetic modification technologies, even if undertaken with the best of intentions, is accompanied by novel human health, environmental, social, economic and other risks. To date, much of the research that has accompanied the release of genetically modified (GM) crops has focused on the environmental and health impacts. Evidence has been inconclusive, however, with debates remaining highly divided and contested, and each “camp” presenting evidence to support its position. [PDF]

ICT and Mobile Data for Health Research

Abstract Mobile cellular subscriptions had reached 87% of the world’s population by 2011 (ITU 2011). Notably, Africa has “the fastest mobile phone growth rate in the world and … a proliferation of social media users” (Mutula in Information ethics in Africa: cross-cutting themes. African Centre of Excellence for Information Ethics, Pretoria, pp 29–42, 2013:31). Mobile phones that can run software applications (apps) are increasingly used in health settings, for example, to improve diagnosis and personalize health care (Mosa et al. in BMC Medical Informatics and Decision Making 12(1):67, 2012). This fast-paced development saw the number of “mHealth” apps reach 97,000 as of March 2013 (He et al. in AMIA Annual Symposium Proceedings, pp 645–654, 2014). [PDF]

Safety and Security Risks of CRISPR/Cas9

Abstract This case study looks into recent developments with regard to the CRISPR/Cas9 and other novel genome editing technologies that are becoming widely available thanks to their low costs and modest technological requirements. [PDF]

Seeking Retrospective Approval for a Study in Resource-Constrained Liberia

Abstract The increase in the volume of health-related research in Africa has not everywhere been accompanied by improvements in research oversight systems related to biomedical and health services research, including the strengthening of institutional review boards (IRBs) and national regulatory oversight institutions. Critical to such oversight are not only competencies in ethics for the review of clinical trials, but also competencies in diverse research methods, statistical anal- yses and project implementation. In Liberia, there are recognized weaknesses in the existing infrastructure and capacity to regulate and monitor clinical research based on ethical institutional regulations and guidance for the protection of human re- search participants. During the height of the Ebola virus disease (EVD) surge in Liberia in 2014, there was a fragile national regulatory framework to oversee research. Some researchers took undue advantage of this gap to conduct unethical research. [PDF]

Legal and Ethical Issues of Justice: Global and Local Perspectives on Compensation for Serious Adverse Events in Clinical Trials

Abstract A 78-year-old Chinese woman joined a clinical trial sponsored by a pharmaceutical company. Unfortunately a serious adverse event (SAE) occurred. The sponsor paid for the cost of the medical care arising from the SAE, but refused the family’s request for compensation. The family then sued the company and the hospital in Beijing. Although the SAE was related to a complication of lower extremity angiography and not the drug itself, it was a direct consequence of participating in the trial. According to Good Clinical Practice, a set of regulations promulgated under Chinese law, “the sponsor should provide insurance to those human subjects who participate in clinical trials, cover the cost of treatment and the corresponding economic compensation for the occurrence of the harm or death associated with the trial” (SFDA in Good clinical practice. State Food and Drug Administration,2003: art. 43). … [PDF]


R. Mathur, R.K. Hazam, K. Thakur (2017). When Patients Become Guinea Pigs – A fictitious case of ethics dumping based on real events. Case study for TRUST project. [PDF]

O. Kubar (2016). Compliance mechanisms available in Russia to ensure adherence to high ethical guidelines. TRUST Project. [PDF]

O. Kubar (2017). Medical Research involving Animals in Russia – an Overview. TRUST Project. [PDF]

J. Rath (2017). International Best Practices regarding Biosafety and Biosecurity. A report for TRUST Project. [PDF]

Z. Xinqing, Z. Wenxia, Z. Yandong (2017). The Chinese Ethical Review System and its Compliance Mechanisms. TRUST Project. [PDF]

Global Code of Conduct - The Book

An open access Springer book about the Code will be released here in Spring 2019. It will provide the in-depth story of the code development and provide further information on the following topics:

Introduction – The need for a Global Code of Conduct for Research in Resource-Poor Settings

Ethics Dumping is the practice of exporting unethical research practices to low-and-middle-income countries (LMICs). Research that would be prohibited or severely restricted in a high-income country (HIC) is then carried out in a setting with lower regulatory capacity. This introductory chapter will summarize Ethics Dumping cases published in a previous Springer Brief; relate the recorded cases to the need to formulate a Global Code of Conduct for Research in Resource-Poor Settings and briefly introduce all further chapters. 

A value-based Global Code of Conduct to avoid ethics dumping

This chapter reprints the Global Code of Conduct for Research in Resource-Poor Settings, which will be launched in May 2018. It is suitable as an awareness-raising tool and as guidance for new and established researchers of all disciplines and for funders concerned about Ethics Dumping. 

Fairness, Respect, Care and Honesty – A discussion

Values inspire, motivate and engage people to discharge obligations or duties. This chapter defines the four values chosen to structure the Global Code of Conduct for Research in Resource-Poor Settings after extensive engagement activities. The values are compared to the four principles by Beauchamp and Childress (non-maleficence, beneficence, autonomy and justice) and an argument is made for their use.  

Exploitation risks in international research

In order to build the code, an exploitation risk table was produced. Risks were categorized according to the points at which vulnerability occurred, and were grouped according to the four values of fairness, respect, care and honesty. Trustworthiness is achieved when all four values are realized for all stakeholders (Persons, Institutions, Local communities, Countries) as well as Animals and the Environment. This chapter explains the exploitation risk table. 

The story of how the code was built 

The code was developed through extensive engagement with highly vulnerable populations, researchers, research councils, policy advisors, industry representatives and research funders. In addition, it was built on existing codes, which were carefully analysed. This chapter describes the engagement activities that were undertaken and concludes on the analysis of existing codes to protect vulnerable populations in resource-poor settings from exploitation in research. 

The San Code of Research Ethics – four values in action 

The San Code of Research Ethics was launched in March 2017 and achieved instant attention by international journals such as Nature, Scientific American and Science. Like its sister code described in this book, the San code is built around the values of fairness, respect, care and honesty. This chapter will summarize developments over the last 20 years, which were necessary before the San community in the South African Kalahari were able to launch their code for partnerships with researchers. A first assessment will be made to see whether the code can reduce the exploitation of the San community in research. 

Good practice to counter Ethics Dumping 

A code is not enough to avoid ethics dumping. Even well-meaning researchers need good examples to build their equitable research partnerships. This chapter will introduce engagement techniques with local communities, a complaints procedure, which is accessible to highly vulnerable populations and summarize a resource built in parallel to the code, a fair research contracting tool. 

Equitable research partnerships – a conclusion

This chapter summarizes the main conclusions from the book and explains which further action is needed to reduce ethics dumping.

Fair Research Contracting

When research contracts are negotiated between teams from high-income and teams from low-and-middle income settings, significant imbalances of power may exist.
TRUST developed a toolkit to provide guidance and highlight key issues in this context.
The FRC website is hosted by COHRED. To access, please click here

Involving Vulnerable Populations in Research

In August 2018, a guide for Community Participation in Research will become available. To supplement the guide, a model Feedback Procedure will also be made available.

The development of the Global Code of Conduct for Research in Resource-Poor Settings has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 664771