Kate Chatfield

The PREPARED Code is a risk-based, values-driven framework that integrates research ethics and research integrity and is designed for a global audience. Developed over two years, this ambitious initiative required a collaborative, multidisciplinary effort led by an international team. The PREPARED team employed a range of methods to develop the code, including literature searches, scoping reviews, empirical studies, targeted consultations, ethical and legal analyses, and public consultation. This chapter explores the processes and methods used to develop the PREPARED Code, highlighting how real-world challenges in research ethics and research integrity during crises were identified, analysed and validated by stakeholders. It describes how these challenges were aligned with universally recognised moral values and grouped as risks, and how the risks were transformed into a clear, focused and jargon-free code of conduct. It also details the final stages of development, which involved iterative refinement of the code from Version 1 to Version 13, through extensive consultation and review.

The Global Code of Conduct for Research in Resource-Poor Settings (GCC) aims to stop the export of unethical research practices from higher to lower income settings. Launched in 2018, the GCC was immediately adopted by European Commission funding streams for application in research that is situated in lower and lower-middle income countries. Other institutions soon followed suit. This article reports on the application of the GCC in two of the first UK-funded projects to implement this new code, one situated in India and one in Pakistan. Through systematic ethics evaluation of both projects, the practical application of the GCC in real-world environments was tested. The findings of this ethics evaluation suggest that while there are challenges for implementation, application of the GCC can promote equity in international research collaborations.

This chapter sets the scene for the development of the PREPARED Code: A Global Code of Conduct for Research During Pandemics. Recalling the time when successive waves of the COVID-19 pandemic led to the deaths of millions and put health systems under enormous pressure, we explain how the pandemic created a demand for rapidly available, trusted scientific advice. Fast reaction systems, including accelerated research, faced significant ethics and integrity challenges. While most such challenges encountered during the COVID-19 pandemic were not unique, researchers and research ethics committees were ill-equipped to cope with their extent and scale. This chapter explains the purpose of the PREPARED Code against that backdrop, including what sets this code apart from many other research ethics codes.

As the risks of ethics and integrity breaches are higher during times of crisis, guidance that enables accelerated research without violating ethics values is essential. This chapter draws upon the lessons learned from a broad range of activities underpinning the development of the PREPARED Code to make recommendations for future developers of ethics codes. Recommendations take the form of key ingredients to help future developers enhance the effectiveness and credibility of ethics codes: building the code on real world risks, aligned with moral values, through transparent and inclusive development processes and with implementation support.

This chapter explains the conceptual foundations of the PREPARED Code, which together provide the credibility required to justify adding yet another ethics code to the thousands that already exist. The code is built on real-world risks identified in nine languages rather than, for instance, on drafters’ expertise, thereby making it as precisely honed an instrument as possible to cope with the real-world ethics and integrity challenges experienced during a pandemic. The code is values-driven, focused on the values of fairness, respect, care and honesty, to harness the motivational power of moral values and to provide an easily understandable, globally applicable moral framework. Unlike most other ethics codes, the PREPARED Code unites research ethics and research integrity guidance into one, to ensure that a culture of integrity rather than a box-ticking mentality is fostered. The short, jargon-free code text addresses all research disciplines and, most importantly, it is based on extensive input from a wide range of stakeholders, including highly marginalised populations, to ensure that it is fit for purpose.

This open-access book is an essential read for anyone interested in pandemic preparedness, research governance, and the ethical oversight of research. It examines the development of a pioneering research ethics framework designed for use during pandemics, guiding readers through the careful development of the PREPARED Code, while highlighting the key steps and lessons learned. The book also underscores the importance of supportive measures, such as user-friendly ethics training, to ensure effective implementation. Drawing from these insights, it offers recommendations for others seeking to develop their own clear, engaging, and accessible ethics code.

What do ethics codes and guidelines tell us about who is vulnerable in research? To what are they vulnerable? And how might this vulnerability be addressed? These questions guided our analysis of 57 research ethics codes and guidelines that mention the involvement of vulnerable persons in research. The chapter draws upon the findings from this analysis to help explain how and why some people might be excluded from research unnecessarily. The investigation is also informed by the findings from an empirical study into the perspectives of 22 researchers who have extensive experience of undertaking research with vulnerable individuals. Their encounters with research governance measures, including research ethics approvalEthics approval and research ethics codes, expose challenges that can exacerbate unnecessary exclusionExclusion from research. We learn from the researchers and the research ethics codes that governance measures intended to protect the vulnerable from exploitationExploitation in research can lead to unfair exclusionExclusion when applied in a blanket fashion. Research governance guidelines and processes must encourage a more nuanced understanding of what it means to be vulnerable in research to ensure that people are not left behind unnecessarily.

Engaged researchEngaged research, which strengthens research teams through community researchersCommunity researchers, offers many opportunities and challenges. From better access to community members who are hard to reach, to the collection of more meaningful and authenticAuthentic data, and greater trustworthiness of research findings, the benefitsBenefits for research are manifold. However, research has also shown that community researchersCommunity researchers might be overtly biased, only collect superficial data or lack the confidenceConfidence to probe deeply enough, among other challenges. Simultaneously, the literature on community researchersCommunity researchers is heavily biased towards high-income countries, and there is very little to be found on experiences from low-and middle-income countries that goes beyond assistance in obtaining informed consentInformed consent. This chapter starts to close that gap by presenting a case study involving 12 community researchersCommunity researchers from the South African San community. Collecting no personal dataPersonal data and obtaining all research input through community researchersCommunity researchers shows that research led by vulnerable groups for vulnerable groups is possible. It is one way of ensuring that the San, and wider research communities, have access to research they can trustTrust.

The Indigenous San peoples, often referred to as South Africa’s “First Peoples”, experienced a violent history of displacement and genocideGenocide. Modern-day San still suffer from the intergenerational traumaIntergenerational trauma inflicted by colonists as well as discriminationDiscrimination, marginalisationMarginalisation and impoverishment. In addition, the South African San are collectively labelled as a vulnerable group, whose inclusionInclusion in research should be reduced to a minimum if one follows traditional protection mechanisms from research ethics. The purpose of this chapter is to let the San define “vulnerability” for themselves through workshops and community-administered surveysSurvey. It became clear that San representatives did not perceive the word “vulnerable” to be pejorative per se. On the contrary, it served as a useful umbrella term to cover a vast range of issues and problems. However, it also became clear that the term is perceived as negative when external actors block research—in a potentially patronisingPatronising manner—that could be beneficial to the community. Equitable research partnershipsEquitable partnerships between researchers and South African San community members, facilitated by the South African San CouncilSouth African San Council and guided by the San Code of Research EthicsSan code of research ethics, can lead to rich data that have the potential to assist the community in finding ways out of vulnerability. Externally labellingLabelling them as “vulnerable” as a group and blocking access to research cannot be the solution.

Sex work is one of the most stigmatised professions in many parts of the world. In Kenya, where it is also illegalIllegal, sex workers can even face rapeRape and abuseAbuse at the hands of law enforcement agents when it becomes known how they earn a living. As a result, sex workers rarely disclose their profession to familyFamily members, let alone outsiders. This means that the involvement of Kenyan sex workers in research over the years has been highly risky, as most research efforts collect personal dataPersonal data. This chapter describes a four-stage investigation into how sex workers define vulnerability for themselves. The approach was community-driven, community-led and, in the main, community-analysed. Importantly, no personal dataPersonal data was collected, and all engagement was undertaken by trusted facilitators and a sex worker community researcherCommunity researchers. Findings showed that structural vulnerabilities are intersectionalIntersectional and stigma-aggravated. At the root may be povertyPoverty, but the stress created by being stigmatised can lead to mental healthMental health problems which, in turn, can aggravate povertyPoverty and stigmaStigma. The KiswahiliKiswahili term mnyongeMnyonge may capture the essence of vulnerability, expressing a sense of weaknessWeakness without the ability to defend oneself.

Leaving no one behindLeaving no one behind is the main transformative promise of the UN’s 2030 Agenda for Sustainable Development. It encapsulates the 21st-century mission of inclusionInclusion. This chapter introduces the main mission of this book: leaving no one behindLeaving no one behind in research. It provides the context for all the chapters that follow by explaining what it means to leave no one behind in research, how the protection-inclusionInclusion dilemma for vulnerable groups and individuals is generated, and how risksRisk and mistrust in research might be reduced. The book was written in collaboration with two groups who are traditionally labelled as highly vulnerable and are therefore often excluded from research: the South African San community and an impoverished sex worker community in Nairobi. Working closely throughout all research stages with the two communities, including co-authorship of this book, we prioritised research-participant needs over researcher needs, aiming for minimally risky and minimally burdensome research, as well as increased trustTrust in researchers. This involved foregoing the collection of personal dataPersonal data and obtaining all research input through community researchersCommunity researchers. It led to a potential alternative to exclusionExclusion from research, namely research led by vulnerable groups for vulnerable groups.

This concluding chapter summarises how we challenged the protection-inclusionInclusion dilemma in order to avoid leaving people behind in research unnecessarily. The fact remains that individuals from highly impoverished, stigmatised groups in lower-income settings face a high likelihood of being harmed and exploited in research. However, excluding them from research is not the answer and can also be seen as a patronisingPatronising interference in the lives of people who might benefitBenefits from research and might welcome long-term relationshipsLong-term relationships of trustTrust with researchers. Achieving long-term relationshipsLong-term relationships of trustTrust requires research methods that strive to be minimally burdensome and minimally risky. In the context of working with the South African San and the Nairobi sex workers, this means that we had to avoid all personal dataPersonal data collection. It also required community involvement at all stages of the research. A key consideration, often lacking from the wider literature, is how community researchersCommunity researchers are identified, trained and supported. In our work, this involved trusted community members leading the trainingTraining, and the use of storytelling, humourHumour and SocraticSocratic methods to encourage reflexivityReflexivity, compassionCompassion and sensitivity. Notable findings generated from our work include that ‘vulnerability’ is not lost in translation, even though the English term is not readily translatable into relevant other languages, or where the main stressors—such as the stigmatisationStigmatisation, discriminationDiscrimination, marginalisationMarginalisation and abuseAbuse besetting the sex worker community—cannot simply be subsumed under “vulnerability”, because they involve specific individual actors who bring about hardship. Our work identifies an approach for leaving no one behindLeaving no one behind in research that can stimulate a deeper understanding of how equitable research partnershipsEquitable partnerships with highly marginalised groups can be achieved.

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.

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.

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.

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.

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.

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.

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.

Humans use and abuse animals for many purposes, including the production and testing of traditional and complementary medicine (T&CM) products. While some animals may benefit from T&CM interventions, many more suffer harm. In both animal experimentation and for the production of T&CM products, animals can be exposed to stress, pain, artificially induced diseases and/or ultimately killed. However, the use of animals in T&CM products (for example, oil extracted from the blubber of the River Dolphin or the intestines of a porcupine) is more ethically challenging than the use of animals in T&CM research. First, research is better regulated. Second, animals used in research are often bred for purpose whereas most of the animals used for T&CM products are taken from the wild in an unregulated manner and many are endangered species such as rhinos, and tigers. Ethical challenges for the use of animals in T&CM products are analysed together with potential for adoption of the same ethical principles that govern animal experimentation (replacement, reduction, refinement).

Open access. This open-access book discusses vulnerability and the protection-inclusion dilemma of including those who suffer from serious poverty, severe stigma, and structural violence in research. Co-written with representatives from indigenous peoples in South Africa and sex workers in Nairobi, the authors come down firmly on the side of inclusion. In the spirit of leaving no one behind in research, the team experimented with data collection methods that prioritize research participant needs over researcher needs. This involved foregoing the collection of personal data and community researchers being involved in all stages of the research. In the process, the term ‘vulnerability’ was illuminated across significant language barriers as it was defined by indigenous peoples and sex workers themselves. The book describes a potential alternative to exclusion from research that moves away from traditional research methods. By ensuring that the research is led by vulnerable groups for vulnerable groups, it offers an approach that fosters trust and collaboration with benefits for the community researchers, the wider community as well as research academics. Those living in low-income settings, in dire situations that are summarized with the term ‘vulnerability’ know best what their problems are and which priorities they have. To exclude them from research for their own protection is a patronizing approach which insinuates that researchers and research ethics committees know best. The team from this book have shown that minimally risky and minimally burdensome research tailored towards the needs of highly marginalized and stigmatized communities can be scientifically valuable as well as inclusive and equitable. I congratulate them. Prof. Klaus Leisinger, President Global Values Alliance, Former personal advisor to Kofi Annan on corporate responsibility.

Evidence suggests that the incidence of research misconduct is not in decline despite efforts to improve awareness, education and governance mechanisms. Two responses to this problem are favoured: first, the promotion of an agent-centred ethics approach to enhance researchers’ personal responsibility and accountability, and second, a change in research culture to relieve perceived pressures to engage in misconduct. This article discusses the challenges for both responses and explains how normative coherence through values alignment might assist. We argue that research integrity and research ethics convey mixed messages, which are likely to contribute to a form of normative confusion. For the successful adoption of an agent-centred approach, normative coherence is needed between the two. To facilitate normative coherence, we propose that research ethics and research integrity be underpinned by a shared set of moral values that can be enacted via codes and guidelines and imbue research environments. Furthermore, to facilitate culture change, the same normative coherence is necessary at all levels of an institution. Only via values alignment between institutional aims, management, institutional practices and researchers can an ethical culture become truly embedded in research institutions.

Achieving equity in international research is one of the pressing concerns of the twenty-first century. In this era of progressive globalization, there are many opportunities for the deliberate or accidental export of unethical research practices from high-income regions to low- and middle-income countries and emerging economies. The export of unethical practices, termed “ethics dumping,” may occur through all forms of research and can affect individuals, communities, countries, animals, and the environment. Ethics dumping may be the result of purposeful exploitation but often arises from lack of awareness of good ethical and governance practice. This chapter describes the work of the TRUST project toward counteracting the practice of ethics dumping through the development of tools for the improvement of research governance structures. Multi-stakeholder consultation informs all of TRUST’s developments. Most importantly, this gives voice to marginalized vulnerable groups and indigenous people, who have been equal and active partners throughout the project. At the heart of the TRUST project is an ambitious aim to develop a Global Code of Conduct for Research in Resource-Poor Settings. Uniquely, the Code provides guidance across all research disciplines in clear, short statements, focusing on research collaborations that entail considerable imbalances of power, resources and knowledge and using a new framework based on the values of fairness, respect, care, and honesty. The code was recently adopted by the European Commission as a reference document for Horizon 2020 and Horizon Europe.

The use of traditional and complementary medicines (T&CMs) is both ubiquitous in low and middle income countries and highly contested in some sections of high income countries. Whilst T&CMs are promoted as an accessible and affordable health care system by high level health policy makers (for example, the Director General of the World Health Organization), their use is simultaneously indicted as a waste of resources, non-scientific, and unethical. The aim of this thesis is to provide a calm, considered and well researched view on a highly emotional topic: What is the nature of the ethical challenges for the use and practice of TCMs and how might they be addressed? The methodology chosen for the ambitious topic of this thesis is the Ethical Matrix as developed by Ben Mepham in the UK in the 1990s. It is founded upon a principlist approach to ethical analysis and has been used widely in decision-making for new technologies. It requires the consideration of interests of stakeholders including, but also beyond, human beings. For the purpose of this thesis four groups were selected: human users of T&CM, the environment, animals, and low and middle income countries (LMICs). Ethical analysis reveals that: • Most ethical concerns associated with T&CMs are related to safety issues for human users; • there are also serious concerns about the way in which animals are routinely harmed through use in T&CM products and T&CM research; • the production and use of some T&CMs does have damaging impacts upon the environment and, • the ethical challenges associated with the use of T&CM in LMICs are different from those in high income countries. Based on the analysis, the thesis provides clear steps to be taken to reduce the potential for harm from both adverse drug reactions and adverse events for humans as well as recommendations to reduce the harm to animals and the environment from use of T&CMs.