Ethics and Integrity in Health and Life Sciences Research: Volume 4

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 largest ever outbreak of Ebola virus disease (EVD), which began in December 2013, profoundly impacted not only the West African countries of Guinea, Sierra Leone, and Liberia, and to a lesser extent Nigeria, but also the rest of the world because some patients needed to be managed in high-resource countries. As of March 29, 2016, there were 28,616 confirmed, probable, and suspected cases of EVD reported in Guinea, Liberia, and Sierra Leone during the outbreak, with 11,310 deaths (case fatality rate of 39.5%). An unprecedented number of healthcare workers and professionals, including physicians, nurses, logistic and administrative personnel, housekeepers, epidemiologists, statisticians, psychologists, sociologists, and ethics experts in many countries, were directly or indirectly involved in the care of EVD patients.

The provision of medical care to critically ill EVD patients would have been challenging in any setting but was especially so in the remote and resource-limited areas where patients were stricken by EVD. Limited health personnel, medical supplies, and equipment, along with inadequate knowledge and skills for minimizing the risks of transmission to healthcare workers, could have led to the de-prioritization of patient care. However, ethical considerations demanded aggressive patient care (intensive care, dialysis, central vascular catheter indwelling, etc.) to produce positive outcomes without increasing the risks to healthcare workers and caregivers.

A major ethical consideration was that healthcare workers have a double obligation: while providing the best medical care to improve EVD patient survival, with symptom relief and palliation as required, they must also protect themselves and minimize further transmission to others, including their colleagues. During the 2014–2015 EVD epidemic, another ethical and clinical problem arose in relation to the management of healthcare workers deployed in Africa who acquired EVD while caring for infected patients. As of June 24, 2015, a total of 65 individuals had been evacuated or repatriated worldwide from the EVD-affected countries, of whom 38 individuals were evacuated or repatriated to Europe. The need for evacuation and repatriation, together with associated ethical issues, is discussed in this chapter.

The chapter deliberates on research ethics and the unanticipated side effects that technological developments have brought in the past decades. It looks at data protection and privacy through the prism of ethics and focuses on the need for safeguarding the fundamental rights of the research participants in the new digital era. Acknowledging the benefits of data analytics for boosting scientific process, the chapter reflects on the main principles and specific research derogations, introduced by the EU General Data Protection Regulation. Further on, it discusses some of the most pressing ethics concerns, related to the use, reuse, and misuse of data; the distinction between publicly available and open data; ethics challenges in online recruitment of research participants; and the potential bias and representativeness problems of Big Data research. The chapter underscores that all challenges should be properly addressed at the outset of research design. Highlighting the power asymmetries between Big Data studies and individuals’ rights to data protection, human dignity, and respect for private and family life, the chapter argues that anonymization may be reasonable, yet not the ultimate ethics solution. It asserts that while anonymization techniques may protect individual data protection rights, the former may not be sufficient to prevent discrimination and stigmatization of entire groups of populations. Finally, the chapter suggests some approaches for ensuring ethics compliance in the digital era.

Big Data analysis is one of the key challenges to the provision of health care to emerge in the last few years. This challenge has been spearheaded by the huge interest in the “4Ps” of health care (predictive, preventive, personalized, and participatory). Big Data offers striking development opportunities in health care and life sciences. Healthcare research is already using Big Data to analyze the spatial distribution of diseases such as diabetes mellitus at detailed geographic levels. Big Data is also being used to assess location-specific risk factors based on data of health insurance claims. Other studies in systems medicine utilize bioinformatics approaches to human biology which necessitate Big Data statistical analysis and medical informatics tools. Big Data is also being used to develop electronic algorithms to forecast clinical events in real time, with the intent to improve patient outcomes and thus reduce costs.

Yet, this Big Data era also poses critically difficult ethical challenges, since it is breaking down the traditional divisions between what belongs to public and private domains in health care and health research. Big Data in health care raises complex ethical concerns due to use of huge datasets obtained from different sources for varying reasons. The clinical translation of this Big Data is thus resulting in key ethical and epistemological challenges for those who use these data to generate new knowledge and the clinicians who eventually apply it to improve patient care.

Underlying this challenge is the fact that patient consent often cannot be collected for the use of individuals’ personal data which then forms part of this Big Data. There is also the added dichotomy of healthcare providers which use such Big Data in attempts to reduce healthcare costs, and the negative impact this may have on the individual with respect to privacy issues and potential discrimination.

Big Data thus challenges societal norms of privacy and consent. Many questions are being raised on how these huge masses of data can be managed into valuable information and meaningful knowledge, while still maintaining ethical norms. Maintaining ethical integrity may lack behind in such a fast-changing sphere of knowledge. There is also an urgent need for international cooperation and standards when considering the ethical implications of the use of Big Data-intensive information.

This chapter will consider some of the main ethical aspects of this fast-developing field in the provision of health care, health research, and public health. It will use examples to concretize the discussion, such as the ethical aspects of the applications of Big Data obtained from clinical trials, and the use of Big Data obtained from the increasing popularity of health mobile apps and social media sites.

Most research ethic review procedures refer to the principles of safety and security only as sub-criteria of other ethical principles such as the protection of human subjects in research, thereby ignoring the public good aspect of safety and security. In addition, Research Ethics Review Committees (RECs) are usually dominated by philosophers, ethicists, medical doctors, and lawyers with limited practical backgrounds in safety and security risk management. This gap of knowledge restricts ethics reviews in carrying out project-specific safety and security risk management and defers this responsibility to lawmakers and national legal authorities. What might be sufficient in well-regulated and well-understood environments, such as the safety of individuals during clinical research, is insufficient in managing rapidly changing and emerging risks – such as with emerging biotechnologies – as well as addressing the public good dimension of safety and security.

This chapter considers governance approaches to safety and security in research. It concludes that legal mechanisms are insufficient to cope with the complexity of and the fast progress made in emerging technologies. The chapter also addresses the role and potential of research ethics as a safety and security governance approach. It concludes that research ethics can play an important role in the governance of such risks arising from emerging technologies, for example through fundamental rights and public good considerations. However, in reality the current capacity of ethics in the safety and security governance of emerging technologies is limited. It is argued that in newly emerging areas of research currently applied legal compliance–based approaches are insufficient. Instead, inclusion of fundamental risk management knowledge and closer interactions between scientists, safety, and security experts are needed for effective risk management. Safety and Security Culture provide frameworks for such interactions and would well complement the current legal compliance–based governance approaches in research ethics.

The chapter analyses the re-emergence of gene editing as an object of policy attention at the European Union (EU) level. Editing the genome of plants and/or animals has been a rather controversial component of all EU policies on agricultural biotechnology since the late 1980s. The chapter examines in detail the various initiatives that have been assumed for the regulation of gene editing at the EU level. Since the first political and legislative attempts, the field has been revolutionized with the development of the CRISPR-Cas9 system, which is comparatively much easier to design, produce, and use. Beyond the pure, safety-driven scientific questions, gene editing, in its contemporary form, raises a series of ethical and regulatory questions that are discussed in the context of the legal options and competences of the EU legislators. Special attention is paid to questions about the legal status of gene editing in Europe and the adequacy of the current GMO framework to deal with all the challenges associated with the latest scientific developments in the field of gene editing with a special focus on gene drive. Given the ongoing discussions regarding the ethical tenets of gene editing, the chapter investigates the question on whether there is a need to shape an EU-wide “intervention” that will address the complex and dynamic socio-ethical challenges of gene editing and puts forward a series of proposals for the framing of an inclusive framework that will be based on the need to re-enforce public trust in the EU governance of emerging technologies.

For more than 20 years, genome editing has been one of the numerous technologies developed for the study and manipulation of the genome. However, since the relatively recent appearance of the so-called precision approaches, and especially through the “CRISPR revolution,” the modification of the genome of any living beings on our planet has become possible, despite recent results showing some unexpected and undesirable effects of this technology. The objective of this chapter is to illustrate how a mobilization of the scientific community through the setting-up of an association should allow a responsible and ethical use of these technologies with considerable impacts for our society.

Extant and newly developing techniques and technologies generated by research in brain sciences are characteristically employed in clinical medicine. However, the increasing capabilities conferred by these approaches to access, assess and affect cognition, emotion and behavior render them viable and attractive for engagement beyond the clinical realm, in what are referred to as “dual-use” applications. Definitions of what constitutes dual-use research and applications can vary so as to include utilization in the public sector for lifestyle or wellness purposes – with growing participation of a do-it-yourself (i.e., biohacking) community, and an iterative interest and use in military and warfare operations. Such uses can pose risks to public safety, and challenge research ethics’ principled imperative for non-harm (although while complete avoidance of any harm may be in reality impossible, certainly any/all harms incurred should be minimized). Thus, it is important to both clarify the construct of dual-use brain research and address the ethical issues that such research fosters. This chapter provides a review and clarification of the concept of dual-use brain science, and describes how current and emerging tools and techniques of brain research are actually or potentially employed in settings that threaten public health and incur ethical concerns. Key ethical issues are addressed, and recommendations for ethical guidance of potentially dual-use research are proposed.

This chapter aims to provide an overview of the ethical framework and decision-making in clinical dementia research, and to analyze and discuss the ethical challenges and issues that can arise when conducting clinical dementia research.

Informed consent is the most scrutinized and controversial aspect of clinical research ethics. In clinical dementia research, assessing decision-making capacity may be challenging as the nature and progress of each disease influences decision-making capacity in diverse ways. Persons with dementia represent a vulnerable population deserving special attention when developing, implementing, and evaluating the informed consent process. In this chapter, particular attention will be given to vulnerability categories and how these influence decision-making capacity. Ethical frameworks with a pragmatic contour and implication are needed to protect vulnerable patients from potential harms and ensure their optimal participation in clinical dementia research.

In addition, this chapter analyses important ethical challenges and issues in clinical dementia research. If handled thoughtfully, they would not pose insuperable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and cause harm to research participants. Ethical considerations in research involving persons with dementia primarily concern the representation of the interests of the participants with dementia and protection of their vulnerabilities and rights.

A core set of ethical questions and recommendations are drawn to aid researchers, institutional review boards and potential research participants in the process of participating in clinical dementia research.

Diet therapy or nutritional therapy has become a real challenge in the fight against the increasing number of modern illnesses such as obesity, diabetes, cardiovascular diseases and cancers. The scientific community has recognized the importance of studies that will support or rebut the association of certain nutrition/energy inputs with the prevention and/or improvement of certain diseases. Patient counseling is offered by medical doctors, nutritionists and dieticians, but patients often seek additional sources of information from popular media that may not be adequately scientifically supported. Whose responsibility is it when the Diet Therapy is not an effective treatment and where does the consequent ethical and moral responsibility lie?

This chapter argues for the importance of a nutritionally educated scientist evaluating the diets that are seen to be related with the health improvement also excluding diets that are mostly related to the patients’ well-being as the Mediterranean, DASH (Dietary Approaches to Stop Hypertension), Ketogenic and Vegetarian diet. Diet guidelines are often explained with linguistic variables (as “reduce the input of” etc.) which can be differently perceived by the end user. The interpretation if a linguistic variable is presented using the body mass index categories using a bell-shaped curve. The preferable area fits to the linguistic variable “acceptable BMI.” But also are indicated those areas which are less preferable. Those examples of information interpretations show the necessity of knowledge transfer. The quantity of information presented in diet guidelines can be experienced as a great muddle for patients; leaving them not knowing where and how to start. So, remains the ethical and moral responsibility of all links in the chain of nutritional and diet research and recommendations. Only objective and open-minded recommendations based on the latest scientific facts can gain confidence of the social, economical, and political subjects which must put the well-being of the population uppermost in their mind.

Nutrition, as a science, is poorly understood, both professionally and publicly. The confusion that surrounds this science makes it very difficult, if not impossible, to formulate public health policy, which creates opportunities for political manipulation and control. Nutrition, for a century or more, has been variously described as a summation of the physiological and biochemical properties of individual nutrients in food rather than the whole food itself. This infers that isolated nutrients in supplements will function in the same way as nutrients in food. It also infers that removing or minimizing “undesirable” nutrients from food will make the food more healthful. This arises from the highly reductionist way that we focus on individual nutrients minus their natural context, both the context within the foods of which they are a part and the context within biological systems where they function. The shortcomings of this belief system may be illustrated by hugely costly mistakes made in the past, even more than a century ago, that corrupt current practices. Such mistakes have become so embedded in the contemporary narrative on nutritional science, both fundamentally and practically, that we fail to recognize the damage they continue to cause.

Alternatively, when nutritional effects are considered more within their natural contexts, that is, more wholistically, then it helps to explain, for example, the remarkable ability of nutrition, as provided by a whole food plant-based diet, to prevent even to cure varied types of cardiovascular disease. Furthermore, the breadth of this nutritional effect for a wide variety of illnesses and diseases suggests that nutrition, properly provided by a whole food plant-based diet, is more efficacious than a combination of all the contemporary pills and procedures combined. It also suggests that genetic determinism is not the explanation for disease that is widely advanced. And finally, among still more consequences, there are many societal outcomes that can be substantially mitigated, including the escalating cost of health care and the dangerously increasing array of destructive practices that damage the environment. Many of the momentous health, economic, environmental and sociopolitical problems currently faced may be traced to a misunderstanding of the effects of food and nutrition. The task therefore is how to bring this message to the attention of a public who for too long have gradually adopted flawed food production and healthcare systems that are on the verge of collapse, threatening the collapse of entire societies as we know them. More specifically, a public and professional dialog on the meaning of nutrition, especially its wholistic properties, is desperately needed, especially in medical schools where nutrition as a science is almost totally ignored.