Cross-sectorial, dynamic, and innovative partnerships are essential to resolve the challenges of humankind in the 21st century. At the same time, trust in each other’s integrity and good will is a precondition for the solution of any complex problem, and certainly for the success of the United Nations Sustainable Development Agenda. Experience shows that a nation’s economic and social success is at its greatest if, and when, there is cooperation and even cocreation involving a fair division of labor and responsibility (...) among the different societal stakeholders. This paper uses Ralf Dahrendorf’s seminal work on obligations, as well as the European Commission’s Science with and for Society unit’s definition of responsible research and innovation (RRI), to motivate industry responsibilities to make the world a healthier place. (shrink)

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely (...) variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping. (shrink)

Research Ethics, Volume 18, Issue 1, Page 24-38, January 2022. Are social science, cross-border research projects, where recruitment and data collection are carried out remotely, required to follow similar ethical and data-sharing procedures as ‘on-the-ground’ studies that use traditional means of recruitment and participant engagement? This article reflects on our experience of dealing with this question when we had to switch to online data collection due to the restrictions posed by the COVID-19 pandemic, such as the inability to travel or (...) work in person with local communities and collaborators. Using social media platforms and online data collection when conducting research brings many advantages, such as being able to communicate remotely but directly with gatekeepers and collaborators, and in reaching potential participants on a global scale. However, neither the guidelines and advice for conducting ethically sound internet-based research, nor the academic literature focussed on building equitable research partnerships between the Global North and the Global South, offer much information regarding the ethical concerns, or address the grey areas, posed by this type of digital and distanced transnational research. In our experience, conducting research remotely made negotiations of access very challenging due to the politics of positionality between Global North and South researchers, lack of clarity on ethical processes and perceptions of gatekeepers who we could not meet in person. We hope the reflections on, and discussion of, our experience encourage deliberation on the present ethical challenges posed by online and social-media-disseminated data collection, particularly in cross-border circumstances. (shrink)

This open access book offers insights into the development of the ground-breaking Global Code of Conduct for Research in Resource-Poor Settings (GCC) and the San Code of Research Ethics. Using a new, intuitive moral framework predicated on fairness, respect, care and honesty, both codes target ethics dumping – the export of unethical research practices from a high-income setting to a lower- or middle-income setting. The book is a rich resource of information and argument for any research stakeholder who opposes double (...) standards in research. It will be indispensable for applicants to European Union framework programmes, as the GCC is now a mandatory reference document for EU funding. (shrink)

This paper explores that the topic of ethics dumping, its causes and potential remedies. In ED, the weaknesses or gaps in ethics policies and systems of lower income countries are intentionally exploited for intellectual or financial gains through research and publishing by higher income countries with a more stringent or complex ethical infrastructure in which such research and publishing practices would not be permitted. Several examples are provided. Possible ED needs to be evaluated before research takes place, and detected prior (...) to publication as an academic paper, because it might lead to a collaborative effort between a wealthier country with restrictive ethical policies and a less wealthy country with more permissive policies. Consequently, if that collaboration ultimately results in an academic paper, there are ethical ramifications of ED to scholarly communication. Institutional review board approval is central to avoid ED-based collaborations. Blind trust and goodwill alone cannot eliminate the exploitation of indigenous or “vulnerable” populations’ intellect and resources. Combining community-based participatory research using clear codes of research conduct and a simple but robust verification system in academic publishing may reduce the risks of ED-based research from being published. (shrink)

A multitude of legislation impacts the use of samples and data for research in South Africa. With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must also be considered (...) and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders. (shrink)

Human Infection Studies have emerged as an important research approach with the potential to fast track the global development of vaccines and treatments for infectious diseases, including in low resource settings. Given the high level of burdens involved in many HIS, particularly prolonged residency and biological sampling requirements, it can be challenging to identify levels of study payments that provide adequate compensation but avoid ‘undue’ levels of inducement to participate. Through this embedded ethics study, involving 97 healthy volunteers and other (...) research stakeholders in a malaria HIS programme in Kenya, and using in-depth interviews, focus group discussions and observations during and after a malaria HIS, we give a grounded account of ethical issues emerging in relation to study payments in this setting. While careful community, national, international scientific and ethics review processes meant that risks of serious harm were highly unlikely, the levels of motivation to join HIS seen could raise concerns about study payments being too high. Particular value was placed on the reliability, rather than level, of study payment in this setting, where subsistence livelihoods are common. Study volunteers were generally clear about the study aims at the point of recruitment, and this knowledge was retained over a year later, although most reported experiencing more burdens than anticipated at enrolment. Strict study screening procedures, regular clinical and laboratory monitoring of volunteers, with prompt treatment with antimalarial at predetermined endpoints suggested that the risks of serious harm were highly unlikely. Ethical concerns emerged in relation to volunteers’ attempts to conceal symptoms, hoping to prolong residency periods and increase study payments; and volunteers making decisions that compromised important family relationships and personal values. Our findings support an interpretation that, although study volunteers were keen to join the study to access cash payments, they also paid attention to other features of the study and the general clinical research landscape, including levels of risk associated with study participation. Overall, our analysis shows that the ethical concerns emerging from the study payments can be addressed through practical measures, hinged on reducing burdens and strengthening communication, raising important issues for research policy and planning. (shrink)

Given some of the various possible impacts of clinical germline editing, we can expect robust disagreement about how best to regulate it. One can point to examples of the promise of editing: “rough...

Across disciplines there is a large and increasing number of research projects that rely on data collection activities in low- and middle-income countries (LMICs). However, these are accompanied by an extensive range of ethical challenges. While the safeguarding of study participants is the primary aim of existing ethics guidelines, this paper argues that this “do no harm” principle should be extended to include research staff. This study is a comprehensive review of more than 80 existing ethics guidelines and protocols that (...) reveals a lack of safeguarding research staff regarding the ethical challenges faced during data collection activities in LMICs. This is particularly the case when it comes to issues such as power imbalances, political risk, staff’s emotional wellbeing or dealing with feelings of guilt. Lead organizations are called upon to develop guiding principles that encompass the safeguarding of research staff, which are then to be adapted and translated into specific protocols and tools by institutions. (shrink)

Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)