Over the last two decades, there was an upsurge of research and innovation in biotechnology and related fields, leading to exciting new discoveries in areas such as the engineering of biological processes, gene editing, stem cell research, CRISPR-Cas9 technology, Synthetic Biology, recombinant DNA, LMOs and GMOs, to mention only a few. At the same time, these advances generated concerns about biosafety, biosecurity and adverse impacts on biodiversity and the environment, leading to the establishment of Research (...) class='Hi'>Ethics Committees (RECs) at Higher Education and Research Institutions dedicated to reviewing research with implications for biosafety and the environment. -/- These Biosafety and Environment Research Ethics Committees, referred to as EBRECs, are in the early stages of their establishment and formalisation, and there is much uncertainty about their composition, scope, procedures of decision-making and the principles that should guide their deliberations and assessments. In many respects, EBRECs are venturing into uncharted territory, facing a very wide range of complex research fields, far-reaching research practices and deep concerns new to Review Boards, raising the question to what extent EBRECs can fall back on the fairly well-established principles and procedures of RECs focusing on Human, Health or Animal research, and to what extent they need new or adapted principles and procedures. -/- Against this background, I set out to answer the following three main research questions in this thesis: 1. What is the current state of ethical principles for ethics reviews in the field of environmental and biosafety research ethics? Which principles are currently used in this context, and how? 2. What are the shortcomings of the current principles used by EBRECs and how can they be overcome? 3. What ethical principles must be adopted by environmental and biosafety research ethics committees and guide them in their decision-making? -/- In order to prepare the ground and set the scene for my discussion of these questions, I also formulated four supporting research questions: i. What is environmental research ethics in action? ii. What is biosafety research ethics in action? iii. How are environmental and biosafety ethics related to one another? iv. How should the guidelines and ethical principles related to these two overlapping fields be implemented in the ethics review process? Following my introduction and problem statement in Chapter 1, I devoted Chapters 2 and 3 to an overview of my supporting questions to set the scene for Environmental and Biosafety Research Ethics. In Chapter 4, I turned to my main research question with a discussion of national and international declarations, frameworks and legislation and an investigation of principles in the different research areas to get a picture of applicable principles that can guide EBRECs. -/- The main finding of my thesis is that due to the complexity of EBR, different categories of principles could be the solution for EBRECs. I elaborate on this in Chapter 5, my concluding chapter, in which I also propose a list of core principles that can serve as an accessible and easy-to-use guide for EBRECs in their decision-making. In this proposal, I cluster different kinds of principles in terms of four categories: 1. Principles as a Moral Concept 2. Principles as a Social Concept 3. Principles as a Legal Concept 4. Principles as a Safety Concept . (shrink)

Agricultural biotechnology refers to a diverse set of industrial techniques used to produce genetically modified foods. Genetically modified (GM) foods are foods manipulated at the molecular level to enhance their value to farmers and consumers. This book is a collection of essays on the ethical dimensions of ag biotech. The essays were written over a dozen years, beginning in 1988. When I began to reflect on the subject, ag biotech was an exotic, untested, technology. Today, in the first year (...) of the millenium, the vast majority of consumers in the United States have taken a bite of the apple. Milk produced by cows injected with a GM protein called recombinant bovine growth hormone (bGH), is found, unlabelled, on grocery shelves throughout the US. In 1999, half of the soybeans and cotton harvested in the US were GM varieties. Billions of dollars of public and private monies are being invested annually in biotech research, and commercial sales now reach into the tens of billions of dollars each year. Whereas ag biotech once promised to change American agriculture, it now is in the process of doing so. (shrink)

Research ethics committees must sometimes deliberate about objects that do not fit nicely into any existing category. This is currently the case with the “gastruloid,” which is a self-assembling blob of cells that resembles a human embryo. The resemblance makes it tempting to group it with other members of that kind, and thus to ask whether gastruloids really are embryos. But fitting an ambiguous object into an existing category with well-worn pathways in research ethics, like the (...) embryo, is only a temporary fix. The bigger problem is that we no longer know what an embryo is. We haven’t had a non-absurd definition of ‘embryo’ for several decades and without a well-defined comparison class, asking whether gastruloids belong to the morally relevant class of things we call embryos is to ask a question without an answer. What’s the alternative? A better approach needs to avoid what I’ll refer to as “the potentiality trap” and, instead, rely on the emergence of morally salient facts about gastruloids and other synthetic embryos. (shrink)

Public discussions of ethical issues related to the biotechnology industry tend to treat "biotechnology" as a single, undifferentiated technology. Similarly, the pros and cons associated with this entire sector tend to get lumped together, such that individuals and groups often situate themselves as either "pro-" or "anti-" biotechnology as a whole. But different biotechnologies and their particular application context pose very different challenges for ethical corporate decision-making. Even within a single product category, different specialty products can pose (...) strikingly different ethical challenges. In this paper, we focus on the single over-arching category of "genetic testing" and compare tests for disease susceptibility and drug response. We highlight the diversity of ethical challenges - grouped under the broad categories of "truth in advertising" and "protecting intellectual property" - raised by the commercialization and marketing of these technologies. By examining social and technical differences between genetic tests, and the associated corporate ethics challenges posed by their commercialization, our intent is to contribute to the nascent business ethics literature examining issues raised by the development and marketing of genetic tests. (shrink)

Scientific literacy is built on critical thinking. The postbaccalaureate workforce enhances our economies and societies by contributing a wealth of knowledge and skill sets to local communities, respective industries, and beyond as our world becomes increasingly interconnected. Education in scientific literacy should teach students how to learn about science and how to cultivate and communicate a positive attitude about science. Learners in a 200-level nonmajors biotechnology course engaged with a series of ethical dilemmas after mastering the basic elements of (...) argument structure and advanced tools in argument evaluation. To introduce collaboration as a constructive process in undergraduate education, student interactions with peers require guidance, flexibility, and compassion to learn from each other. Students gain critical thinking mastery from two modules addressing how we argue and evaluate claims. Students apply these critical thinking skills to various ethical arguments involving responsible conduct of research training. Using our structured and interdisciplinary approach, new scholars learn through practice how to read, analyze, and evaluate research scenarios and respond to potential ethical situations. This strategy allows students to develop important scholarly skills, including a systematic approach to evaluating credibility and applying generosity to theirs and others' understanding of their circumstances. (shrink)

Genetically engineered (GE) insects, such as the GE OX513A Aedes aegypti mosquitoes, have been designed to suppress their wild-type populations so as to reduce the transmission of vector-borne diseases in humans. Apart from the ecological and epidemiological uncertainties associated with this approach, such biotechnological approaches may be used by individual governments or the global community of nations to avoid addressing the underlying structural, systemic causes of those infections... We discuss here key ethical questions raised by the use of GE mosquitoes, (...) with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by outlining a procedural approach to decision-making about the use of the “biotechnology” that goes beyond “community engagement.” The protocol we advocate for entails informed deliberations and decision-making at the community level. It is designed to ensure that the voices of the marginalized and vulnerable groups that would be disproportionately affected by the decision are heard during the community-wide discussions. Moreover, we make the case that the values embedded in the risk assessment should be identified so that the community can make an informed decision about the use of GE insects. In addition, we advocate for the involvement of a variety of actors whose responsibility would be to ensure that the community has the opportunity to make an informed decision based on deliberations about the use of the “biotechnology.”. (shrink)

This book provides answers to the questions that biomedical and biotechnological research has posed to our societies by proposing the introduction of biorights. It shows how bioscience affects our individual and social lives by discussing and answering important questions such as; Are we becoming more vulnerable and unable to protect ourselves? How can we ensure fairness and justice with regards to the access to health care? Are human dignity, autonomy and equality at risk? Do we need new and special (...) rights: neurorights, genetic rights? What is the meaning and scope of the right to life, health, privacy or non-discrimination? Biorights are the suggested solution for dealing with these challenges. Healthcare professionals, bio-researchers, policy makers, scholars, and citizens will, in this book, find a guide to knowing how bioscience affects our lives. Furthermore, this book provides a comprehensive method for biomedical and biotechnological decision-making that comprises human or basic rights dimensions alongside technical and ethical dimensions. (shrink)

This article examines when deceptive withholding of information is ethically acceptable in research. The first half analyses the concept of deception. We argue that there are two types of accounts of deception: normative and non-normative, and argue that non-normative accounts are preferable. The second half of the article argues that the relevant ethical question which ethics committees should focus on is not whether the person from whom the information is withheld will be deceived, but rather on the reasonableness (...) of withholding the information from the person who is deceived. We further argue that the reasonableness of withholding information is dependent on the context. The last section examines how the context of research should shape our judgements about the circumstances in which withholding information from research participants is ethically acceptable. We argue that some important features of research make it more difficult to justify withholding information in the context of research than elsewhere. (shrink)

Health data processing fields face ethical and legal problems regarding fundamental rights. As we know, patients can benefit in the Digital Era from having health or medical information available, and medical decisions can be more effective with a better understanding of clinical histories, medical and health data thanks to the development of Artificial Intelligence, Internet of Things and other Digital technologies. However, at the same time, we need to guarantee fundamental rights, including privacy ones. The complaint about ethical and legal (...) requirements – including constitutional ones – is particularly relevant in the processing of health data. This paper is focused on the problem of the consent required to the processing of health data and the exceptions established in the new European Union General Data Regulation, which cover the processing of this special data -within other aims- for scientific, historical and statistical research as legitimate purposes, which include biomedical research. The conclusion is that these open concepts are problematic both for the protection of privacy rights and for the legal security/certainty of research. On one hand there are several interpretation problems, regarding the processing of health data and the protection of information privacy. On the other hand, professionals must follow the Multilevel legal framework and to guarantee fundamental rights in the processing of health data, so there are also problems of interpretation for researchers. Therefore, we need a clearer legal framework for biomedical research. (shrink)

Should we do whatever science lets us do? This short introduction in the 'All That Matters' series shows how developments in biotechnology, such as genetics, stem cell research and artificial reproduction, arouse both our greatest hopes and our greatest fears. Many people invest the new biotechnology with all the aspirations and faith once accorded to religious salvation. But does everyone benefit equally from scientific progress? This book argues that although we've entered new scientific territory, there is no (...) need to jettison our existing moral sense. By discussing a range of real-life cases, it equips readers to make up their own minds on these important questions. Good science and good ethics needn't be contradictory. (shrink)

Much of contemporary research ethics was developed in the latter half of the twentieth century as a response to the unethical treatment of human beings in biomedical research. Research ethical considerations have subsequently been extended to cover topics in the sciences and technology such as data handling, precautionary measures, engineering codes of conduct, and more. However, moral issues in the humanities have gained less attention from research ethicists. This article proposes an ethical principle for reading (...) for research purposes: Respect the author. (shrink)

This paper assesses the state of research ethics in low- and middle-income countries and the achievements of the Fogarty International Center's bioethics training program since 2000. The vision of FIC for the next decade of research ethics education is encapsulated in four proposed goals: (1) Ensure sufficient expertise in ethics review by having someone with long-term training on every high-workload REC; (2) Develop LMIC capacity to conduct original research on critical ethical issues by supporting (...) doctoral and postdoctoral training and career paths for research ethicists; (3) Make research training and review at LMIC institutions sustainable by identifying additional funding mechanisms and models; (4) Make institutional research systems more ethical and efficient through context-specific training integrated into all levels of scientific training. (shrink)

Background -/- Emerging technologies and societal changes create new ethical concerns and greater need for cross-disciplinary and cross–stakeholder communication on navigating ethics in research. Scholarly articles are the primary mode of communication for researchers, however there are concerns regarding the expression of research ethics in these outputs. If not in these outputs, where should researchers and stakeholders learn about the ethical considerations of research? Objectives -/- Drawing on a scoping review, analysis of policy in a (...) specific disciplinary context (learning and technology), and reference group discussion, we address concerns regarding research ethics, in research involving emerging technologies through developing novel policy that aims to foster learning through the expression of ethical concepts in research. Approach -/- This paper develops new editorial policy for expression of research ethics in scholarly outputs across disciplines. These guidelines, aimed at authors, reviewers, and editors, are underpinned by: -/- a cross-disciplinary scoping review of existing policy and adherence to these policies; a review of emerging policies, and policies in a specific discipline (learning and technology); and, a collective drafting process undertaken by a reference group of journal editors (the authors of this paper). -/- Results -/- Analysis arising from the scoping review indicates gaps in policy across a wide range of journals (54% have no statement regarding reporting of research ethics), and adherence (51% of papers reviewed did not refer to ethics considerations). Analysis of emerging and discipline-specific policies highlights gaps. Conclusion -/- Our collective policy development process develops novel materials suitable for cross-disciplinary transfer, to address specific issues of research involving AI, and broader challenges of emerging technologies. (shrink)

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help (...) ensure that scarce resources such as tissue samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

NIH's fogarty international Center has provided grants for the development of training programs in international research ethics for low- and middle-income (LMIC) professionals since 2000. Drawing on 12 years of research ethics training experience, a group of Fogarty grantees, trainees, and other ethics experts sought to map the current capacity and need for research ethics in LMICs, analyze the lessons learned about teaching bioethics, and chart a way forward for research ethics (...) training in a rapidly changing health research landscape. This collection of papers is the result. (shrink)

Research on research ethics—regarding both the governance and practice of the ethical review of human subjects research—has a tumultuous history in North America and Europe. Much of the academic literature focuses on issues to do with regulating the conduct and quality of ethics review of research protocols by ethics committees (research ethics boards (REBs) in Canada and institutional review boards (IRBs) in the United States). In addition, some of the literature attends (...) to issues particular to the review of qualitative research, and still other literature addresses the challenges posed by and the need for research on REBs/IRBs. It is this third group of literature within which our article is situated. (shrink)

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to (...) which the role of the REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role. (shrink)

Ongoing research in the fields of genetics and biotechnology hold the promise of improved diagnosis and treatment of genetic diseases, and potentially the development of individually tailored pharmaceuticals and gene therapies. Difficulty, however, arises in determining how these services are to be evaluated and integrated equitably into public health care systems such as Canada's. The current context is one of increasing fiscal restraint on the part of governments, limited financial resources being dedicated to health care, and rising costs (...) for new health care services and technologies. This has led to increasing public debate in the last few years about how to reform public health care, and whether we should prohibit, permit or perhaps even encourage private purchase of health care services. ;In Canada, some of these concerns have crystallized around the issue of gene patents and commercial genetic testing, in particular as illustrated by the case of Myriad Genetics' patented BRACAnalysis test for hereditary breast and ovarian cancer. While most Canadians who currently access genetic services do so through the public health care system, for those with the means, private purchase is becoming an option. This situation raises serious concerns---about justice in access to health care; about continued access to safe and reliable genetic testing supported by unbiased patient information; and about the broader effects of commercialization for ongoing research and the Canadian public health care system. Commercial genetic testing presents a challenge to health care professionals, policy analysts, and academics concerned with the social, ethical and policy implications of new genetic technologies. Using the Myriad case as an exemplar, tools from moral philosophy, the social sciences, and health policy and law will be brought to bear on the larger issues of how as a society we should regulate commercial research and product development, and more coherently decide which services to cover under public health insurance and which to leave to private purchase. Generally, the thesis is concerned with the question of "how best to bring capital, morality, and knowledge into a productive and ethical relationship". (shrink)

Social Science relies heavily on the use of ethnography and other forms of qualitative study, research that may place the researcher as well as their subjects at significant ethical risk. In Canada, Research Ethics Boards are responsible for protecting research participants during these studies. But how much ethical oversight ought the Research Ethics Boards be entitled to? Are they repressing valuable qualitative studies or are the Social Science simply rebelling against new but appropriate control (...) mechanisms not formerly applied to them? This paper evaluates how well the changes made in the TCPS 2 respond to the concerns of Social Scientists as presented in the literature. (shrink)

In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the (...) lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to (...) the dangers of research but largely silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical (...) agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials. (shrink)

Although continued investments in nanotechnology are made, atomically precise manufacturing (APM) to date is still regarded as speculative technology. APM, also known as molecular manufacturing, is a token example of a converging technology, has great potential to impact and be affected by other emerging technologies, such as artificial intelligence, biotechnology, and ICT. The development of APM thus can have drastic global impacts depending on how it is designed and used. This paper argues that the ethical issues that arise from (...) APM - as both a standalone technology or as a converging one - affects the roles of stakeholders in such a way as to warrant an alternate means furthering responsible innovation in APM research. This paper introduces a value-based design methodology called Value Sensitive Design (VSD) that may serve as a suitable framework to adequately cater to the values of stakeholders. Ultimately, it is concluded that VSD is a strong candidate framework for addressing the moral concerns of stakeholders during the preliminary stages of technological development. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research (...) to improve emergency care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (shrink)

The creation of guidelines has long been a popular means of conveying normative requirements in scientific and medical research. The recent case of He Jiankui, whose research flouted both widely accepted ethical standards and a set of field-specific guidelines he co-authored, raises the question of whether guidelines are an effective means of preventing misconduct. This paper advances the theory that guidelines can facilitate moral rationalization, a form of motivated reasoning. Moral rationalization in research occurs when individuals justify (...) their actions with plausible reasons that cohere with their moral standards. This allows them to act as they want while believing in their own goodness. If guidelines facilitate moral rationalization, this has implications for research ethics training and for the work of applied ethicists. Research ethics training ought to incorporate reflection on conative features of reasoning, including incentives to commit misconduct, and applied ethicists ought to be circumspect about their use of ethics guidelines. Otherwise, they are feeding the fire of rationalization with the cognitive material practitioners need to accomplish their desired ends. (shrink)

Genetics research and biotechnology development - while holding the promise of improved pharmaceuticals, medical treatments, and foods - is also raising concerns about the impact of market forces on scientific inquiry, product development, and the provision of health care.

Those who care about and engage in politics frequently fall victim to cognitive bias. Concerns that such bias impacts scholarship recently have prompted debates—notably, in philosophy and psychology—on the proper relationship between research and politics. One proposal emerging from these debates is that researchers studying politics have a professional duty to avoid political activism because it risks biasing their work. While sympathetic to the motivations behind this proposal, I suggest several reasons to reject a blanket duty to avoid activism: (...) (1) even if it reduced bias, this duty would make unreasonable demands on researchers; (2) this duty could hinder research by limiting viewpoint diversity; (3) this duty wrongly implies that academia offers a relative haven from bias compared to politics; and (4) not all forms of political activism pose an equal risk of bias. None of these points suggest that researchers should ignore the risk of bias. Rather, researchers should focus on stronger evidence-based strategies for reducing bias than a blanket recommendation to avoid politics. (shrink)

Social scientists and research ethicists have begun, somewhat belatedly, to confront and address the ethical challenges raised by public policy experiments. In doing so however, they have not fully availed themselves of the large and sophisticated literature on the ethics of clinical research which has developed over the past 40 years. While clinical and public policy research are different, I argue that the clinical research ethics literature yields valuable insights for discussions of the (...) class='Hi'>ethics of policy experiments. Focusing on seven ethical issues which have received a good deal of attention in public and scholarly discussions of the ethics of policy experiments, I make use of the history of reflection on the ethics of clinical research to provide guidance to researchers planning and conducting policy experiments. (shrink)

Seventy-five years before Niander Wallace brutally kills a newborn replicant in Blade Runner 2049, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed. Its formation led to the creation of the Belmont Report, which established guidelines for the treatment of human subjects. Wallace uses a scalpel as the instrument of disposal, of the newborn replicant, stabbing her in the womb, thereby ending her life moments after wishing her a happy birthday. The conjunction (...) of 2049 and the Belmont Report leads us to important questions concerning biomedical research, given that replicants are “bioengineered humans.” For example, is the “defective” replicant a human subject, and thus protected by research guidelines, or is she a product or consumer good that did not meet expectations? (shrink)

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some (...) studies the Institutional Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency. (shrink)

The principal goal of Alex John London's For the Common Good is to "articulate a new vision for the philosophical foundations of research ethics" which "moves issues of justice from the periphery of the field to the very center." At the core of this new vision is an understanding of research as a "collaborative social activity between free and equal persons," which aims to develop the knowledge public institutions require to establish and maintain a social order in (...) which people may set and pursue their plans of life. Clinical and social scientific research are not therefore morally optional activities, in London's view, but rather the way public institutions acquire the knowledge they... (shrink)

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the (...) class='Hi'>ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)

Background: In prevalence studies of sexually transmitted infections (STIs), investigators often provide syndromic management for symptomatic participants, but may not provide specific treatment for asymptomatic individuals with positive laboratory test results due to the delays between sample collection and availability of results as well as logistical constraints in recontacting study participants. Methods: To characterize the extent of this issue, 80 prevalence studies from the World Health Organization’s Report on global sexually transmitted infection surveillance, 2018, were reviewed. Studies were classified as (...) to whether clinically relevant positive results were returned or if this was not specified. Results: More than half (56%) of the cited studies did not specify if participants were notified of clinically relevant positive STI test results. The percentages were similar for low- and middle-income country populations (57%) and high-income country populations (53%). Conclusions: The absence of documentation of the provision of test results raises the possibility that in some instances, results may not have been communicated, with potential negative effects for participants, their sexual partners, and newborns. From an ethical perspective, clinically relevant results should be returned to study participants and treating clinicians in a timely fashion to ensure appropriate management of identified infections. Study authors should document if they returned test results to study participants and report on numbers lost to follow-up. (shrink)

CITATION: Msimang, P. 2020. Lessons in our faults : fault lines on race and research ethics. South African Journal of Science, 116:8449, doi:10.17159/sajs.2020/8449.

Purpose. Our study aims at developing a conceptual model of transdisciplinary synthesis of philosophical-anthropological, sociopolitical and epistemological aspects of co-evolution of the scientific and technical designs of High Hume class and the socio-cultural / political context in the process of anthropo-socio-cultural genesis. The relevance of the topic is justified by the technologization of all spheres of human existence and the emergence of High Hume class technologies, which can be called technology-driven equally. As a result, the concepts of "bio-power" and "biopolitics" (...) have become ones of the most frequently mentioned in modern philosophical and anthropological discourse and attract increasing attention of philosophers, sociologists, and, in the last decadecades, experts in the field of practical political science and economics (Foucault, Agamben, Žižek, Kebnik, Nadesan, etc.). Theoretical basis. It is problem-theoretical research; We synthesize the results of our publications in recent years. We proceed from the fact that the main question of the informational phase of the development of a technogenic civilization lies in the rationalization and technologization of the evolutionary process, i.e. in the removal of the fundamental ontological antinomy “Evolution versus Reasonable Design”, as a result for modern neoliberal political democracy, biopower and its theoretical understanding (biopolitics) are effective tools and technologies to form of optimal trends of the global evolutionary process, in the framework of this ideological system. We have chosen the comparative conceptual analysis combining with the results of the content analysis of Web publications by the main method of the study. Originality of the research is in the fact that the central core of such a model is the use of a conceptual and terminological apparatus for describing the mechanisms of the progressive evolution of complex systems, known as the “triple spiral” by Ledeisdorf-Itskovich. This allowed us to integrate the bio-power phenomenon into the general scheme of a stable evolutionary strategy of a technogenic civilization. The conclusions. We justified the transformation of biopolitics into the main factor in the global evolution of self-organizing human-sized systems, including the biosphere as a whole. This is achieved through the creation of a specific (bio) ethical system of imperatives and the activities of individuals in relation to themselves and other agents of social actions. Bioethics with a trail of associated conceptual areas (biosociology, bioeconomics, biohistory, etc.) turned out to be the only rationalized regulator of the process of biological and sociocultural evolution. The triple spiral biotechnology – bioeconomy – bioenergy as the material substance of the life of technological civilization is reflected in the ideal world as a triad of bioethics – biosociology – biopolitics. Both triads form closed cycles of evolutionary transformations that transmit and amplify the initial momentum of transformations on each other through a cascade mechanism with positive feedback. (shrink)

There is too much that we do not know about COVID-19. The longer we take to find it out, the more lives will be lost. In this paper, we will defend a principle of risk parity: if it is permissible to expose some members of society (e.g. health workers or the economically vulnerable) to a certain level of ex ante risk in order to minimize overall harm from the virus, then it is permissible to expose fully informed volunteers to a (...) comparable level of risk in the context of promising research into the virus. We apply this principle to three examples of risky research: skipping animal trials for promising treatments, human challenge trials to speed up vaccine development, and low-dose controlled infection or “variolation.” We conclude that if volunteers, fully informed about the risks, are willing to help fight the pandemic by aiding promising research, there are strong moral reasons to gratefully accept their help. To refuse it would implicitly subject others to still graver risks. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:130 Feminist Studies 46, no. 1. © 2020 by Feminist Studies, Inc. Laura Bisaillon, Alana Cattapan, Annelieke Driessen, Esther van Duin, Shannon Spruit, Lorena Anton, and Nancy S. Jecker Doing Academia Differently: “I Needed Self-Help Less Than I Needed a Fair Society” A great deal of harm is being done by belief in the virtuousness of work. — Bertrand Russell, “In Praise of Idleness” We are committed to doing (...) academia in particular ways, and not in others. — Brocher Foundation Feminist Collective I had decided that becoming a university professor might be a good fit; friends and colleagues had suggested that I would be valuable to a university, so I prepared for a restructuring of my family life.1 I read Tokarczyk and Fay’s Working-Class Women in the Academy and Babcock and Laschever’s Women Don’t Ask to gather understandings of the milieu I was entering. I now see that my preparations had not shined sufficient light on the social and structural factors that organize the contemporary university.... As it turns out, the restructuring of our lives within the working conditions, priorities, and rationalities of this professional milieu triggered unanticipated and painful effects.... Had Mountz published her article “Women on the Edge” before I decided on a career migration into the university system and, had I been fortunate enough to discover it, I would have made other career choices.2 1. The authors, who describe themselves as the Brocher Foundation Feminist Collective, indicate their personal narratives in this text using italics. 2. Michelle M. Tokarczyk and Elizabeth A. Fay, eds., Working-Class Women in the Academy: Laborers in the Knowledge Factory (Amherst: University of Massachusetts Press, 1993); Linda Babcock and Sara Laschever, Women Don’t Ask: Negotiation and the Gender Divide (Princeton, NJ: Princeton University Bisaillon et al. 131 Introduction: Personal, Professional, and Political We are seven women who met at the Brocher Foundation in Hermance, Switzerland, in July 2017, where we had been selected to spend a few months as research fellows. This competitively awarded opportunity is open to persons fluent in English, from graduate students to senior scholars, with or without academic appointment, whose scholarship advances knowledge about the ethical, legal, and social implications of health and biotechnologies.3 When we found ourselves on the shores of Lake Leman with the gift of time, we began opening up to each other in unexpected, compelling ways. Whatever our vantage point in the hierarchy of the university system, we discovered that there was remarkable overlap in our experiences as women in academia. When we began writing, our authoring team was composed of two graduate students, four faculty members at the assistant professor rank, and one full professor, residing in Canada, the Netherlands, Romania, the United Kingdom, and the United States. Our plural subject position led us to underexplored and imaginative responses to broader social issues, which we share in this article as the “Brocher Foundation Feminist Collective.” We analyze our experiences from our standpoint as women health researchers laboring in the academy. Our similarities and differences were exciting entry points for discussion and analysis: we are all of eastern or western European descent. We have different countries of birth, mother tongues, ages, disciplinary training and career trajectories, relationships to chronic illness and disability, marital status, and experiences with parenthood. We bring the troubles and contradictions we experience as academics into conversation with each other. We seek to productively illustrate and emphasize that the tensions we see around us, and also feel within us, arise as a result of how the academic system is organized, produced, and sustained across time, place, and space. Press, 2003); Alison Mountz, “Women on the Edge: Workplace Stress at Universities in North America,” The Canadian Geographer 60, no. 2 (2016): 205–18. 3. We experienced this fellowship as a valuable opportunity. But we also recognized that our access to it was mediated by social, economic, or other obligations. As countries in the global north continue to tighten their national border regimes, marginalized academics, especially those from the global South, were less likely to succeed in getting a Swiss visa or securing relevant temporal and economic resources. 132 Bisaillon et al. The promise here, we posit... (shrink)

Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of (...) class='Hi'>research participants, and communication of research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper. (shrink)

Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review (...) of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. (shrink)

Debates on the role of biotechnology in food production are beset with notorious ambiguities. This already applies to the term “biotechnology” itself. Does it refer to the use and modification of living organisms in general, or rather to a specific set of technologies developed quite recently in the form of bioengineering and genetic modification? No less ambiguous are discussions concerning the question to what extent biotechnology must be regarded as “unnatural.” In this article it will be argued (...) that, in order to disentangle some of the ambiguities involved, we have to broaden the temporal horizon of the debate. Ideas about biotechniques and naturalness have evolved in various socio-historical contexts and their historical origins will determine to a considerable extent their actual meaning and use in contemporary deliberations. For this purpose, a comprehensive timetable is developed, beginning with the Neolithic revolution ~10,000 years ago (resulting in the emergence of agriculture and the Common Human Pattern) up to the biotech revolution as it has evolved from the 1970s onwards—sometimes referred to as a second “Genesis.” The concept of nature that emerged in the context of the “Common Human Pattern” differs considerably from traditional philosophical concepts of nature (such as coined by Aristotle), as well as from the scientific view of nature conveyed by the contemporary life sciences. A clarification of these different historical backdrops will allow us to understand and elucidate the conceptual ambiguities that are at work in contemporary debates on biotechnology and the place of human beings in nature. (shrink)

Providing heroin to heroin addicts taking part in medical trials to assess the effectiveness of the drug as a treatment alternative, breaches ethical research standards, some ethicists maintain. Heroin addicts, they say, are unable to consent voluntarily to take part in these trials. Other ethicists disagree. In our view, both sides of the debate have an inadequate understanding of voluntariness. In this article we therefore offer a fuller conception, one which allows for a more flexible, case-to-case approach in which (...) some heroin addicts are considered capable of consenting voluntarily, others not. An advantage of this approach, it is argued, is that it provides a safety net to minimize the risk of inflicting harm on trial participants. (shrink)

“Love hurts”—as the saying goes—and a certain amount of pain and difficulty in intimate relationships is unavoidable. Sometimes it may even be beneficial, since adversity can lead to personal growth, self-discovery, and a range of other components of a life well-lived. But other times, love can be downright dangerous. It may bind a spouse to her domestic abuser, draw an unscrupulous adult toward sexual involvement with a child, put someone under the insidious spell of a cult leader, and even inspire (...) jealousy-fueled homicide. How might these perilous devotions be diminished? The ancients thought that treatments such as phlebotomy, exercise, or bloodletting could “cure” an individual of love. But modern neuroscience and emerging developments in psychopharmacology open up a range of possible interventions that might actually work. These developments raise profound moral questions about the potential uses—and misuses—of such anti-love biotechnology. In this article, we describe a number of prospective love-diminishing interventions, and offer a preliminary ethical framework for dealing with them responsibly should they arise. (shrink)

. . Tom Beauchamp and David DeGrazia's principles do improve upon the 3Rs which don’t mention the need for benefits from animal experimentation, the need to compare these benefits to animal harms, and provide no hard limits on experimentation. -/- However, they present their principles as “useful” for people engaged in animal research and as a “philosophically sound” (p. 4) framework for a new ethic for animal research. Regrettably, I have doubts about both these overall claims and so (...) am pessimistic about the book. (shrink)

Responsible research and innovation imposes normative requirements on research and innovation processes resembling three successive steps, each more ambitious than its predecessor, with distinct features. For the research dimension the distinct features reflect the normative requirements of, first, credible research ; second, responsive research ; and third, responsible research. Equally distinct features reflect the requirements of credible innovation, responsive innovation, and responsible innovation.

In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise—i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention—has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always (...) justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions. (shrink)

This article summarizes the recommendations concerning robotics as issued by the Commission for the Ethics of Research in Information Sciences and Technologies (CERNA), the French advisory commission for the ethics of information and communication technology (ICT) research. Robotics has numerous applications in which its role can be overwhelming and may lead to unexpected consequences. In this rapidly evolving technological environment, CERNA does not set novel ethical standards but seeks to make ethical deliberation inseparable from scientific activity. (...) Additionally, it provides tools and guidance for researchers and research institutions. (shrink)

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, (...) Health and Policy-relevant Ethics in Singapore Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. (shrink)

Environmental health research produces scientific knowledge about environmental hazards crucial for public health and environmental justice movements that seek to prevent or reduce exposure to these hazards. The environment in environmental health research is conceptualized as the range of possible social, biological, chemical, and/or physical hazards or risks to human health, some of which merit study due to factors such as their probability and severity, the feasibility of their remediation, and injustice in their distribution. This paper explores the (...) ethics of identifying the relevant environment for environmental health research, as judgments involved in defining an environmental hazard or risk, judgments of that hazard or risk's probability, severity, and/ or injustice, as well as the feasibility of its remediation, all ought to appeal to non-epistemic as well as epistemic values. I illustrate by discussing the case of environmental lead, a housing-related hazard that remains unjustly distributed by race and class and is particularly dangerous to children. Examining a controversy in environmental health research ethics where researchers tested multiple levels of lead abatement in lead-contaminated households, I argue that the broader perspective on the ethics of environmental health research provided in the first part of this paper may have helped prevent this controversy. (shrink)

Most public and non-profit organisations that fund health research provide the majority of their funding in the form of grants. The calls for grant applications are often untargeted, such that a wide variety of applications may compete for the same funding. The grant review process therefore plays a critical role in determining how limited research resources are allocated. Despite this, little attention has been paid to whether grant review criteria align with widely endorsed ethical criteria for allocating health (...) research resources. Here, we analyse the criteria and processes that ten of the largest public and non-profit research funders use to choose between competing grant applications. Our data suggest that research funders rarely instruct reviewers to consider disease burden or to prioritise research for sicker or more disadvantaged populations, and typically only include scientists in the review processes. This is liable to undermine efforts to link research funding to health needs. (shrink)