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)

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)

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)

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 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)

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)

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)

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.

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)

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)

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)

. . 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)

Since their discovery in the early 1990s, Stem Cell has brought the prospect of radically improving treatments for a host of diseases such as Alzheimer's, Parkinson's disease, cancers and many among other diseases that currently render patients and scientists helpless to combat. With the advent of medical and scientific research, comes the inevitable emergence of ethical controversy that often accompanied major scientific and medical development. The use of Stem Cell is no different. Those who seek to curtail the use (...) of certain stem cell lines, revert to the argument that has defied many medical debates over the previous decades. The destruction of human life to create life is one of the key philosophical points that all anti-stem cell advocates attempt to make. However, the purpose of this paper is to analysis the various aspects of ethical debate concerning the use of stem cells in medical research. (shrink)

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of (...) patients and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach to overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients. (shrink)

The impacts that AI and robotics systems can and will have on our everyday lives are already making themselves manifest. However, there is a lack of research on the ethical impacts and means for amelioration regarding AI and robotics within tourism and hospitality. Given the importance of designing technologies that cross national boundaries, and given that the tourism and hospitality industry is fundamentally predicated on multicultural interactions, this is an area of research and application that requires particular attention. (...) Specifically, tourism and hospitality have a range of context-unique stakeholders that need to be accounted for in the salient design of AI systems is to be achieved. This paper adopts a stakeholder approach to develop the conceptual framework to centralize human values in designing and deploying AI and robotics systems in tourism and hospitality. The conceptual framework includes several layers – ‘Human-human-AI’ interaction level, direct and indirect stakeholders, and the macroenvironment. The ethical issues on each layer are outlined as well as some possible solutions to them. Additionally, the paper develops a research agenda on the topic. (shrink)

Despite widespread agreement that privacy in the context of education is important, it can be difficult to pin down precisely why and to what extent it is important, and it is challenging to determine how privacy is related to other important values. But that task is crucial. Absent a clear sense of what privacy is, it will be difficult to understand the scope of privacy protections in codes of ethics. Moreover, privacy will inevitably conflict with other values, and understanding (...) the values that underwrite privacy protections is crucial for addressing conflicts between privacy and institutional efficiency, advising efficacy, vendor benefits, and student autonomy. -/- My task in this paper is to seek a better understanding of the concept of privacy in institutional research, canvas a number of important moral values underlying privacy generally (including several that are explicit in the AIR Statement), and examine how those moral values should bear upon institutional research by considering several recent cases. (shrink)

This chapter provides a high-level overview of key ethical issues raised by the use of surveillance technologies, such as digital contact tracing, disease surveillance, and vaccine passports, to combat the COVID-19 pandemic. To some extent, these issues are entirely familiar. I argue that they raise old questions in new form and with new urgency, at the intersection of information ethics, research ethics, and public health. Whenever we deal with data-driven technologies, we have to ask how they fare (...) in relation to important values like privacy, fairness, transparency, and accountability—values emphasized by information ethics scholars. Likewise, when such technologies put individuals at risk in order to drive scientific research and knowledge construction, we have to ask how they implicate values such as autonomy, beneficence and non-maleficence, and justice—values central to research ethics. And as researchers focusing on health information have long argued, when the data collected by these technologies pertain to individuals and public health, these ethical issues take on a special cast. -/- It is also true, however, that the pandemic has placed these questions in a new and revealing light. I highlight three insights from information ethics and research ethics that can help us navigate this difficult terrain. First, the value of privacy is instrumental, not absolute—there is nothing wrong with asking how to balance privacy against other important values. Second, privacy has both individual and social importance. Weighing privacy, on one hand, and public health, on the other, is not, therefore, a contest between individual and collective interests. Rather, it is an attempt to balance disparate public goods. Third, we ought to put these kinds of ethical decisions in the hands of third parties, rather than leaving them up to those who directly stand to benefit from them. In the case of pandemic surveillance technologies, this should mean more public, democratic oversight. (shrink)

On most accounts, beliefs are supposed to fit the world rather than change it. But believing can have social consequences, since the beliefs we form underwrite our actions and impact our character. Because our beliefs affect how we live our lives and how we treat other people, it is surprising how little attention is usually given to the moral status of believing apart from its epistemic justification. In what follows, I develop a version of the harm principle that applies to (...) beliefs as well as actions. In doing so, I challenge the often exaggerated distinction between forming beliefs and acting on them.1 After developing this view, I consider what it might imply about controversial research the goal of which is to yield true beliefs but the outcome of which might include negative social consequences. In particular, I focus on the implications of research into biological differences between racial groups. (shrink)

In recent years, exposome research has been put forward as the next frontier for the study of human health and disease. Exposome research entails the analysis of the totality of environmental exposures and their corresponding biological responses within the human body. Increasingly, this is operationalized by big-data approaches to map the effects of internal as well as external exposures using smart sensors and multiomics technologies. However, the ethical implications of exposome research are still only rarely discussed in (...) the literature. Therefore, we conducted a systematic review of the academic literature regarding both the exposome and underlying research fields and approaches, to map the ethical aspects that are relevant to exposome research. We identify five ethical themes that are prominent in ethics discussions: the goals of exposome research, its standards, its tools, how it relates to study participants, and the consequences of its products. Furthermore, we provide a number of general principles for how future ethics research can best make use of our comprehensive overview of the ethical aspects of exposome research. Lastly, we highlight three aspects of exposome research that are most in need of ethical reflection: the actionability of its findings, the epidemiological or clinical norms applicable to exposome research, and the meaning and action–implications of bias. (shrink)

Geoscience research may upset people even though it is ethically acceptable. In this paper we attempt to explore three questions about such research. It will turn out that (1) under most circumstances ethical but upsetting geoscience research is morally permissible, (2) revising this research in response to upset-induced external interference is morally impermissible in the absence of strong countervailing pragmatic reasons and attempts to reduce upset, and (3) potentially upsetting geoscience research ought to be communicated (...) truthfully and tailored to each individual situation. These general propositions are applied to a case of ethical but upsetting research that we ourselves are currently involved. (shrink)

This paper presents an ethical framework designed to support the development of critical data literacy for research methods courses and data training programmes in higher education. The framework we present draws upon our reviews of literature, course syllabi and existing frameworks on data ethics. For this research we reviewed 250 research methods syllabi from across the disciplines, as well as 80 syllabi from data science programmes to understand how or if data ethics was taught. We (...) also reviewed 12 data ethics frameworks drawn from different sectors. Finally, we reviewed an extensive and diverse body of literature about data practices, research ethics, data ethics and critical data literacy, in order to develop a transversal model that can be adopted across higher education. To promote and support ethical approaches to the collection and use of data, ethics training must go beyond securing informed consent to enable a critical understanding of the techno-centric environment and the intersecting hierarchies of power embedded in technology and data. By fostering ethics as a method, educators can enable research that protects vulnerable groups and empower communities. (shrink)

Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani & Hyder propose for the ethical review of health policy and systems research (HPSR), or prompt future work in the area.

In the United States, the Presidential Commission for the Study of Bioethical Issues has proposed deliberative democracy as an approach for dealing with ethical issues surrounding synthetic biology. Deliberative democracy might similarly help us as we update the regulation of human subjects research. This paper considers how the values that deliberative democratic engagement aims to realize can be realized in a human subjects research context. Deliberative democracy is characterized by an ongoing exchange of ideas between participants, and an (...) effort to justify decisions that bind participants by appeal to reasons that the participants can understand and share. Even when unanimous agreement is not reached, the active participation of everyone along with the requirement that reasons be made accessible enhances the legitimacy of the ultimate outcome. Importantly, deliberative democratic structures avoid strict hierarchies and place participants, as much as possible, in the position of equals. Human subjects research has some features that may make deliberative democratic principles seem initially unappealing. For one, there are asymmetries in knowledge between expert researchers conducting the research and participants in the research process. For another, statistical validity is made easiest by research paradigms that produce standardized, quantitative data, which can be difficult to achieve if research participants are given the power to deliberatively reshape the research design as it progresses. These and other problems have tended to produce a human subjects research process where subjects do not actively participate in shaping research, but rather consent to a predefined set of interventions designed by expert researchers and vetted by Institutional Review Boards (IRBs). In this paper, I suggest some ways in which human subjects research could do more to realize deliberative democratic values, and, in particular, how a revised Common Rule might help to realize these values. First, research participants could be treated not as passive subjects but instead involved in research design, ethical review, and the ongoing conduct and dissemination of research. Such participation might involve, for instance, including people who have served as research subjects on IRBs, or replacing IRB oversight for certain forms of research exempted from IRB oversight under a revised Common Rule with oversight by a body of community members or research subjects. It might also involve having the oversight of research that uses more participatory models be more participatory and less hierarchical in nature. I also raise questions about the exemption of research on public benefit programs from any research-level oversight and from consent requirements. While IRBs are likely not the correct overseers, there may be good reason to view such research with a critical eye, because of its potential for long-range impacts on the lives of participants. By giving research subjects a greater voice in research that aims at fine-tuning public benefit programs on which subjects rely, a deliberative oversight process has the potential to recast research participation as a form of active democratic participation and to address a “democratic deficit” in public health. Numerous proposals regarding health care have called for greater participation by laypeople and a more nonhierarchical approach to setting health priorities. Involving lay research subjects in the conduct of public benefits research and other forms of public health research may help to further these goals. (shrink)

In this article, we discuss the ethics of research suspensions in animal research facilities and the consequent (mis)treatment of laboratory animals during emergencies. Through a case study from Switzerland during the COVID-19 pandemic, we articulate ethical principles and moral considerations that ought to guide the treatment and care of laboratory animals within animal research facilities during emergencies. They include a principle of preparedness, the importance of recognizing animal laboratory personnel as essential workers and conducting a Harm-Benefit (...) Analysis in the case of an emergency, assigning responsibilities in a clear way, and providing psychological support in the aftermath of an emergency. More generally, we suggest that the pandemic should be taken as a learning opportunity for critically re-evaluating and improving emergency planning within animal research institutions worldwide, in view of mitigating risks to both human and animal well-being in future emergencies. (shrink)

Researches in education are conducted to address educational problems and provide solutions that will stimulate effectiveness within the educational sector. Like other disciplines, educational researches must be conducted without issues or bottlenecks that will hinder the integrity of the study or the researchers. This chapter identifies various issues that are currently practised which are unethical. The chapter also provides insights to the aspects that researchers and scholars must focus in order to ensure that unethical issues are avoided when conducting researches. (...) Conclusions and recommendations were made in order to improve the current practices towards global best practices in educational research management. Keywords:. (shrink)

Recent studies have explored the effectiveness of open-label placebos for a variety of conditions, including chronic pain, cancer-related fatigue and irritable bowel syndrome. OLPs are thought to sidestep traditional ethical worries about placebos because they do not involve deception: with an OLP, patients or subjects are told outright that they are not given an active substance. As deception is framed as the primary hurdle to ethical placebo use, the door is ostensibly opened to ethical studies of OLPs. In this article, (...) I suggest that even though OLPs seemingly do not involve deception, there are other ethical considerations in their clinical investigation and subsequent use. Research ethics often focusses on informed consent—of which, deception and honesty are a piece—as a means to justify research practices with human subjects. Yet, it is but one of the ethical considerations that should be taken into account. With research into placebo effects in particular, I argue that the history of clinical placebo use grounds special considerations for OLP research that go beyond respect for the autonomy of individual patients through informed consent and encompass structural concerns about the type of patient for whom a placebo has historically been thought appropriate. (shrink)

Although the notion of universal human rights allows for the idea that states (and supranational organizations such as the European Union) can, or even should, control and impose restrictions on migration, both notions clearly do not sit well together. The ensuing tension manifests itself in our ambivalent attitude towards migration, but also affects the border guards who have to implement national and supranational policies on migration. Little has been written on the ethics that has to guide these border guards (...) in their work. Juxtaposing the ethics of border guarding against the ethics of the somewhat related military profession, this article attempts to (a) describe border guarding as a comparatively rule-guided profession; (b) outline the aim and basis of the ethics education that prepares border guards for their work; and (c) propose a research agenda for the future that should further our understanding of (a) and (b), but also help us improve the moral education of border guards. (shrink)