TRUST project in London at the Wellcome Trust, June 2017 © Wellcome Trust
The Book about the Code
D. Schroeder, K. Chatfield, M. Singh, R. Chennells, P. Herissone-Kelly. 2019. Equitable Research Partnerships. A Global Code of Conduct to Counter Ethics Dumping. With a foreword by K. Leisinger. Springer Briefs in Research and Innovation Governance.
Available at Springer Link, DOI: 10.1007/978-3-030-15745-6 (open access publication).
Ethics Dumping and the Need for a Global Code of Conduct
Abstract: The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of humanity’s problems, how can the resulting gulf be bridged? This book describes one initiative to counter ethics dumping: the development and promotion of the Global Code of Conduct for Research in Resource-Poor Settings. [PDF]
A Value-Based Global Code of Conduct to Counter Ethics Dumping
Abstract: The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is designed to counter ethics dumping, i.e. the practice of moving research from a high-income setting to a lower-income setting to circumvent ethical barriers. The GCC is reprinted here. It was completed in May 2018 and adopted by the European Commission as a mandatory reference document for Horizon 2020 in August 2018. For more information on the GCC, please visit: https://www.globalcodeofconduct.org/ [PDF]
The Four Values Framework: Fairness, Respect, Care and Honesty
Abstract: Values inspire, motivate and engage people to discharge obligations or duties. This chapter defends the values approach in the context of guarding against ethics dumping, the practice of exporting unethical research from higher-income to lower-income settings. A number of essential questions will be answered: What are values? What is the meaning of the word “value”? Why does it make sense to choose values as an instrument to guide ethical action in preference to other possibilities? And what is meant by fairness, respect, care and honesty? It is concluded that values can provide excellent guidance and aspiration in the fight against ethics dumping, and are therefore a well-chosen structure for the Global Code of Conduct for Research in Resource-Poor Settings. [PDF]
Respect and a Global Code of Conduct?
Abstract: The Global Code of Conduct for Research in Resource-Poor Settings claims global applicability and promotes respect as one of its four values. Hence, the code anticipates potentially unresolvable differences between cultures, while maintaining it is globally valid. Examining, but discarding, several possibilities to deal with normative relativism, this chapter argues, with Beauchamp and Childress (2013, Principles of Biomedical Ethics, 7th edn. Oxford University Press, New York) that values can be internal to morality itself, allowing their global applicability. [PDF]
Exploitation Risks in Collaborative International Research
Abstract: Ethics dumping occurs in collaborative international research when people, communities, animals and/or environments are exploited by researchers. Exploitation is made possible by serious poverty and extreme power differentials between researchers from high-income countries and research stakeholders from low- and middle-income countries (LMICs). To prevent its occurrence, the risks of exploitation have to be tackled. This chapter describes 88 risks identified for collaborative international research, categorized according to four values: fairness, respect, care and honesty. The risks were identified in a broad-based consultative exercise, which included more than 30 members and chairs of ethics committees in LMICs, representatives from vulnerable populations in LMICs, and an open call for case studies of exploitation. The findings of the exercise contributed to the development of the Global Code of Conduct for Research in Resource-Poor Settings. [PDF]
How the Global Code of Conduct Was Built
Abstract: How can an ethics code achieve impact? The answer is twofold. First, through adoption by influential research funders, who then make it mandatory for their award recipients. This is the case with the Global Code of Conduct for Research in Resource-Poor Settings, which was adopted by both the European Commission and the European and Developing Countries Clinical Trials Partnership shortly after its launch in 2018. Second, an ethics code can achieve impact when researchers use it for guidance whether it is compulsory or not. This is most likely to happen with codes that were developed transparently with all research stakeholders involved. This chapter will outline how the GCC was developed, and in particular how external stakeholders were systematically engaged, how existing codes were carefully analysed and built upon, and who the early adopters were. [PDF]
The San Code of Research Ethics
Abstract: The San peoples of southern Africa have been the object of much academic research over centuries. In recent years, San leaders have become increasingly convinced that most academic research on their communities has been neither requested, nor useful, nor protected in any meaningful way. In many cases dissatisfaction, if not actual harm, has been the result. In 2017, the South African San finally published the San Code of Research Ethics, which requires all researchers intending to engage with San communities to commit to four central values, namely fairness, respect, care and honesty, as well as to comply with a simple process of community approval. The code is the first ethics code developed and launched by an indigenous population in Africa. Key to this achievement were: dedicated San leaders of integrity, supportive NGOs, legal assistance and long-term research collaborations with key individuals who undertook fund-raising and provided strategic support. [PDF]
Good Practice to Counter Ethics Dumping
Abstract: An ethics code is not enough to avoid ethics dumping. Ethics codes can inspire, guide and raise awareness of ethical issues, but they cannot, on their own, guarantee ethical outcomes; this requires a multifaceted approach. For research in resource-poor settings, engagement is crucial. Such engagement has been built into the Global Code of Conduct for Research in Resource-Poor Settings as a requirement, but how can it be put into practice? An approach for ethical community engagement is presented in this chapter, which also includes suggestions for an accessible complaints mechanism. At the institutional level, we tackle the question of concluding fair research contracts when access to legal advice is limited. Throughout, at a broader level, we show how the four values of fairness, respect, care and honesty can be used to help guide decision-making and the practical application of the code. [PDF]
Towards Equitable Research Partnership
Abstract: The world’s largest collection of professional ethics codes already holds more than 2,500 codes. What can the Global Code of Conduct for Research in Resource-Poor Settings (GCC) add? This brief chapter gives co-authors and supporters of the GCC the opportunity to show why a code with the single-minded aim of eradicating ethics dumping is needed. [PDF]
Existing guidelines have played an important role in formulating the Global Code. While it is not quoting any of the other guidelines directly, the authors have taken substantial inspiration from the ethics guidelines listed below (click arrow to unfold).
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 ec.europa.eu
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 2011
Roche: Animal Research − Roche Principles of Care and Use 2013
Sanofi: Corporate Social Responsibility Factsheet on 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
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, DOI: 10.1007/978-3-319-64731-9 (open access publication).
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]
Other Publications on Ethics Dumping
D. Schroeder (2017). ‘Ethics dumping’ – the dark side of international research. The Conversation, December 12, 2017.
Available from The Conversation.
Kate Chatfield, Doris Schroeder, Anastasia Guantai, Kirana Bhatt, Elizabeth Bukusi, Joyce Adhiambo Odhiambo, Julie Cook, Joshua Kimani. Research Ethics, first online: 24 May 2020. DOI: 10.1177/1747016120925064 (Open Access)
Available from Research Ethics
When research contracts are negotiated between teams from high-income and low-and-middle income settings, significant imbalances of power may exist. The TRUST project developed a toolkit to provide guidance and highlight key issues in this context. The Fair Research Contracting (FRC) website is hosted by COHRED and includes a self-assessment guide and roadmap to improve the research contracting capabilities of research and academic institutions, organisations and businesses.
The Research Fairness Initiative institutional partnership quality improvement tool is designed to tackle all kinds of research partnership challenges, especially in low- and middle-income countries (LMICs). Now, organizations & academic institutions can take key aspects of collaboration into consideration while promoting national & international partnerships in priority areas of scientific research and technological development for better research process efficiency, innovation and competitiveness. The RFI is directly relevant to the Global Code of Conduct as it promotes fair and equitable research partnerships. You can find out more at https://rfi.cohred.org
Involving Vulnerable Populations in Research
The TRUST guide for community participation in research,“Research with, not about, communities”, gives practical advice on community engagement, an ethical imperative for global researchers. Readers are invited to use the TRUST compass (fairness, respect, care and honesty) during all five research stages (research question, research design, implementation, results, evaluation). The main advice is to build long-term, mutually beneficial relationships to apply before, during and after research studies.
The guide is now available in the Resource Library of the AHRECS website.
Complaints Procedures for Collaborative Research in Resource-poor Settings
An effective complaints procedure offers a channel for raising concerns, both during and after a research study, and should help to ensure compliance with research ethics requirements. For this report, members of the TRUST team drew upon their experiences of working with vulnerable communities in low and middle-income countries (LMICs) to address practical, ethical and legal considerations for dealing with complaints. The document highlights the need for effective, user-friendly complaints procedures which are flexible and culturally sensitive across different forms of research in LMICs.
Available from the Global Code website.
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]