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)

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)

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)

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)

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 (...) class='Hi'>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)

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)

The U.S. review system for human subjects research has been widely criticized in recent years for requirements that delay research without improving human subjects protections. Any major reformulation of regulations may take some time to implement. In the meantime, current regulations often allow for streamlined ethics review without jeopardizing—and possibly improving—protections for research participants. We discuss underutilized options, including research that need not be classified as “human subjects research,” categories of studies that (...) can be exempt from ethical review, and studies that need only undergo expedited review by one IRB member. In addition, we consider ways to simplify review of multi-center research using one institution’s IRB. We speculate on multiple reasons for the underuse of these mechanisms, and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process. (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)

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 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)

It is generally unquestioned that human subjects research review boards should assess the ethical acceptability of protocols. It says so right on the tin, after all: they are explicitly called research ethics committees in the UK. But it is precisely those sorts of unchallenged assumptions that should, from time to time, be assessed and critiqued, in case they are in fact unfounded. John Stuart Mill's objection to suppressers of dissent is instructive here: “If the opinion is (...) right, they are deprived of the opportunity of exchanging error for truth: if wrong, they lose, what is almost as great a benefit, the clearer perception and livelier impression of truth, produced by its collision with error”.1 Andrew Moore and Andrew Donnelly's compelling article, “The job of ‘ethics committees’”, is just this sort of challenge to conventional wisdom, a rejection of the notion that review boards should be considering ethical matters at all.2 If true, we should be substantially reforming our research ethics policies. And if false, rebuttals would help strengthen and ground the otherwise unquestioned assumption of the role of ethics committees. As it happens, I will argue that their critiques fall into the second category. While mistaken, they present a valuable opportunity to clarify the role of ethics committees and their relationship to relevant codes. In particular, I will defend a hybrid account where codes have strict primacy, but leave significant room for review boards …. (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 burden of research ethics review falls not just on researchers, but on those who serve on research ethics committees (RECs). With the advent of automated text analysis and generative artificial intelligence, it has recently become possible to teach models to support human judgment, for example by highlighting relevant parts of a text and suggesting actionable precedents and explanations. It is time to consider how such tools might be used to support ethics review (...) and oversight. This commentary argues that with a suitable strategy of engagement, artificial intelligence can be used in a variety of ways that can genuinely support RECs and manage their workload and improve the quality of review. It would be wiser to take an active role in the development of AI tools for ethics review, rather than to adopt ad hoc tools after the fact. (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)

. . 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)

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)

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)

Some international researchers assume that there is a lack of ethical review of research in many countries of the Global South. However, numerous African countries have recently introduced local and national research ethics guidelines. This article unpacks how ethical reviews of research in education are negotiated in a higher education institution in Ethiopia. It employs a critical analytical lens to challenge some of the assumptions of Beaty’s (2010) Institutional Review Board (IRB) stakeholder model. The (...) article begins with a discussion of the limitations inherent in the IRB model. Critical analyses of institutional documents and non-confidential, off-the-shelf IRB minutes are also conducted. The analysis shows that researchers within the medical and health sciences disciplines have well established organisational engagement when it comes to handling issues related to research ethics. However, limited representation of the educational and social and behavioural science disciplines remains a challenge. Furthermore, ethical issues in conducting educational research are hardly addressed in the national guidelines for granting research ethics approval. This results in further marginalisation of the contributions of educational research to knowledge production. (shrink)

While there has been significant discussion in the health sciences and ethics literatures about problems associated with publication practices (e.g., ghost- and gift-authorship, conflicts of interest), there has been relatively little practical guidance developed to help researchers determine how they should fairly allocate credit for multi-authored publications. Fair allocation of credit requires that participating authors be acknowledged for their contribution and responsibilities, but it is not obvious what contributions should warrant authorship, nor who should be responsible for the quality (...) and content of the scientific research findings presented in a publication. In this paper, we review arguments presented in the ethics and health science literatures, and the policies or guidelines proposed by learned societies and journals, in order to explore the link between author contribution and responsibility in multi-author multidisciplinary health science publications. We then critically examine the various procedures used in the field to help researchers fairly allocate authorship. (shrink)

This article presents the first thematic review of the literature on the ethical issues concerning digital well-being. The term ‘digital well-being’ is used to refer to the impact of digital technologies on what it means to live a life that isgood fora human being. The review explores the existing literature on the ethics of digital well-being, with the goal of mapping the current debate and identifying open questions for future research. The review identifies major issues (...) related to several key social domains: healthcare, education, governance and social development, and media and entertainment. It also highlights three broader themes: positive computing, personalised human–computer interaction, and autonomy and self-determination. The review argues that three themes will be central to ongoing discussions and research by showing how they can be used to identify open questions related to the ethics of digital well-being. (shrink)

We conducted a systematic literature review on the ethical considerations of the use of contact tracing app technology, which was extensively implemented during the COVID-19 pandemic. The rapid and extensive use of this technology during the COVID-19 pandemic, while benefiting the public well-being by providing information about people’s mobility and movements to control the spread of the virus, raised several ethical concerns for the post-COVID-19 era. To investigate these concerns for the post-pandemic situation and provide direction for future events, (...) we analyzed the current ethical frameworks, research, and case studies about the ethical usage of tracing app technology. The results suggest there are seven essential ethical considerations—privacy, security, acceptability, government surveillance, transparency, justice, and voluntariness—in the ethical use of contact tracing technology. In this paper, we explain and discuss these considerations and how they are needed for the ethical usage of this technology. The findings also highlight the importance of developing integrated guidelines and frameworks for implementation of such technology in the post- COVID-19 world. (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.

Background The worldwide increase in older persons demands technological solutions to combat the shortage of caregiving and to enable aging in place. Smart home health technologies (SHHTs) are promoted and implemented as a possible solution from an economic and practical perspective. However, ethical considerations are equally important and need to be investigated. Methods We conducted a systematic review according to the PRISMA guidelines to investigate if and how ethical questions are discussed in the field of SHHTs in caregiving for (...) older persons. Results 156 peer-reviewed articles published in English, German and French were retrieved and analyzed across 10 electronic databases. Using narrative analysis, 7 ethical categories were mapped: privacy, autonomy, responsibility, human vs. artificial interactions, trust, ageism and stigma, and other concerns. Conclusion The findings of our systematic review show the (lack of) ethical consideration when it comes to the development and implementation of SHHTs for older persons. Our analysis is useful to promote careful ethical consideration when carrying out technology development, research and deployment to care for older persons. Registration We registered our systematic review in the PROSPERO network under CRD42021248543. (shrink)

The debate about the ethical implications of Artificial Intelligence dates from the 1960s :741–742, 1960; Wiener in Cybernetics: or control and communication in the animal and the machine, MIT Press, New York, 1961). However, in recent years symbolic AI has been complemented and sometimes replaced by Neural Networks and Machine Learning techniques. This has vastly increased its potential utility and impact on society, with the consequence that the ethical debate has gone mainstream. Such a debate has primarily focused on principles—the (...) ‘what’ of AI ethics —rather than on practices, the ‘how.’ Awareness of the potential issues is increasing at a fast rate, but the AI community’s ability to take action to mitigate the associated risks is still at its infancy. Our intention in presenting this research is to contribute to closing the gap between principles and practices by constructing a typology that may help practically-minded developers apply ethics at each stage of the Machine Learning development pipeline, and to signal to researchers where further work is needed. The focus is exclusively on Machine Learning, but it is hoped that the results of this research may be easily applicable to other branches of AI. The article outlines the research method for creating this typology, the initial findings, and provides a summary of future research needs. (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)

This article has provided a critical review of sampling procedures in the context of Sierra Leone. The basics of the two major types of sampling procedures (probability and non-probability) have been explained, with a view of shedding light on their usage to assist researchers in their pursuance of addressing proposed hypothetical statements. Problems associated with low literacy rate in Sierra Leone have been highlighted as a major concern, more so in the process of ensuring ethical code of conducts are (...) adhered to during the execution of sampling research. Research practices in the country needs a complete overhaul, particularly with its very low investment in ‘Higher Education Institutions (HEIs)’ to help support the backbone of research, and backed by investment in technology to assist with the enhancement of exploring sampling data in pursuit of addressing hypothetical postulates / research questions during research. (shrink)

The case (Dawson et al. 2024) describes an Institutional Review Board (IRB) chair who seeks consultation about waiving the requirement that investigators obtain prospective, informed consent for collection of microbiome samples by swabbing the perianal region of severely burned patients shortly after their admission to an intensive care unit (ICU). We argue that it is ethically permissible to waive informed consent requirements for the perianal swab and that the IRB should approve a waiver as permitted by regulations.

The internet of things is increasingly spreading into the domain of medical and social care. Internet-enabled devices for monitoring and managing the health and well-being of users outside of traditional medical institutions have rapidly become common tools to support healthcare. Health-related internet of things (H-IoT) technologies increasingly play a key role in health management, for purposes including disease prevention, real-time tele-monitoring of patient’s functions, testing of treatments, fitness and well-being monitoring, medication dispensation, and health research data collection. H-IoT promises (...) many benefits for health and healthcare. However, it also raises a host of ethical problems stemming from the inherent risks of Internet enabled devices, the sensitivity of health-related data, and their impact on the delivery of healthcare. This paper maps the main ethical problems that have been identified by the relevant literature and identifies key themes in the on-going debate on ethical problems concerning H-IoT. (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)

Background: Use of patients’ medical data for secondary purposes such as health research, audit, and service planning is well established in the UK. However, the governance environment, as well as public understanding about this work, have lagged behind. We aimed to systematically review the literature on UK and Irish public views of patient data used in research, critically analysing such views though an established biomedical ethics framework, to draw out potential strategies for future good practice guidance (...) and inform ethical and privacy debates. Methods: We searched three databases using terms such as patient, public, opinion, and electronic health records. Empirical studies were eligible for inclusion if they surveyed healthcare users, patients or the public in UK and Ireland and examined attitudes, opinions or beliefs about the use of patient data for medical research. Results were synthesised into broad themes using a framework analysis. Results: Out of 13,492 papers and reports screened, 20 papers or reports were eligible. While there was a widespread willingness to share patient data for research for the common good, this very rarely led to unqualified support. The public expressed two generalised concerns about the potential risks to their privacy. The first of these concerns related to a party’s competence in keeping data secure, while the second was associated with the motivation a party might have to use the data. Conclusions: The public evaluates trustworthiness of research organisations by assessing their competence in data-handling and motivation for accessing the data. Public attitudes around data-sharing exemplified several principles which are also widely accepted in biomedical ethics. This provides a framework for understanding public attitudes, which should be considered in the development in any guidance for regulators and data custodians. We propose four salient questions which decision makers should address when evaluating proposals for the secondary use of data. (shrink)

Ethics dumping is an ongoing practice in collaborative research. Despite the existence of ethical review boards, some notable discrepancy in governance and integration persists. This paper is a chronological book review of a 15-chapter book titled, "Ethics Dumping: Case Studies from North-South Research Collaborations," compiled from individual authors and edited by Schroeder, Cook, Hirch, Fenet, and Muthuswami in 2018. This book review aims to ensure ever-increasing attention to the numerous ways of ethics (...) dumping and incite further research into the matter. The book is a must-read for researchers, ethicists, policymakers in research institutions, and students (especially graduate students). (shrink)

Scientists who engage in science and the scientific endeavor should seek truth with conviction of morals and commitment to ethics. While the number of publications continues to increase, the number of retractions has increased at a faster rate. Journals publish fraudulent research papers despite claims of peer review and adherence to publishing ethics. Nevertheless, appropriate ethical peer review will remain a gatekeeper when selecting research manuscripts in scholarly publishing and approving research applications for (...) grant funding. However, this peer review must become more open, fair, transparent, equitable, and just with new recommendations and guidelines for reproducible and accountable reviews that support and promote fair citation and citational justice. We should engineer this new peer-review process with modern informatics technology and information science to provide and defend better safeguards for truth and integrity, to clarify and maintain the provenance of information and ideas, and to rebuild and restore trust in scholarly research institutions. Indeed, this new approach will be necessary in the current post-truth era to counter the ease and speed with which mis-information, dis-information, anti-information, caco-information, and mal-information spread through the internet, web, news, and social media. The most important question for application of new peer-review methods to these information wars should be ‘Who does what when?’ in support of reproducible and accountable reviews. Who refers to the authors, reviewers, editors, and publishers as participants in the review process. What refers to disclosure of the participants' identities, the material content of author manuscripts and reviewer commentaries, and other communications between authors and reviewers. When refers to tracking the sequential points in time for which disclosure of whose identity, which content, and which communication at which step of the peer-review process for which audience of readers and reviewers. We believe that quality peer review, and peer review of peer review, must be motivated and maintained by elevating their status and prestige to an art and a science. Both peer review itself and peer review analyses of peer reviews should be incentivised by publishing peer reviews as citable references separately from the research report reviewed while crossreferenced and crosslinked to the report reviewed. (shrink)

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)

After severe brain injury, one of the key challenges for medical doctors is to determine the patient’s prognosis. Who will do well? Who will not do well? Physicians need to know this, and families need to do this too, to address choices regarding the continuation of life supporting therapies. However, current prognostication methods are insufficient to provide a reliable prognosis. -/- Functional Magnetic Resonance Imaging (MRI) holds considerable promise for improving the accuracy of prognosis in acute brain injury patients. Nonetheless, (...) research on functional MRI in the intensive care unit context is ethically challenging. These studies raise several ethical issues that have not been addressed so far. In this article, Prof. Charles Weijer and his co-workers provide a framework for researchers and ethics committees to design and review these studies in an ethically sound way. (shrink)

In a recent commentary, Kim and colleagues argued that minimal-risk research should be deregulated so that such studies do not require review by an institutional review board. They claim that regulation of minimal-risk studies provides no adequate counterbalancing good and instead leads to a costly human subjects oversight system. We argue that the counterbalancing good of regulating minimal-risk studies is that oversight exists to ensure that respect for persons and justice requirements are satisfied when they otherwise might (...) not be. (shrink)

This chapter summarizes the reflections of a scientist active in optical communication about the need of ethical considerations in technological research. An optimistic definition of ethics, being the art to make good use of technology, is proposed that emphasizes the necessarily involvement of not only technologists but also experts in humanity. The paper then reviews briefly the research activities of a Dutch national consortium where the author had been involved. This mainly academic research dealt with advanced (...) approaches for ultrafast communication. In the next section an assessment is given of the potential impact of the technological results on society. In order to emphasize the positive aspects and counteract the negative ones, three steps are proposed: (i) create conditions for a dialogue between experts in ethics and technology; (ii) work out scenarios for the introduction of new techniques in society; (iii) anticipate opportunities and threats. Finally the conclusions are presented. (shrink)

This publication constitutes a comprehensive account of the panel discussion entitled “Philosophical and Ethical Analysis of the Concepts of Death and Human Existence in the Context of Cybernetic Immortality” which transpired within the confines of the international scientific symposium “The Seventh Lemovsky Readings” held in Samara from March 28th to 30th, 2024. The aforementioned panel discussion, which congregated scores of erudite scholars representing preeminent research institutions across the Russian Federation, emerged as one of the cardinal events of the conference. (...) Eminent Russian academics hailing from multifarious domains of knowledge engaged in a profound deliberation on the potentialities of cybernetic immortality, the conundrums associated with the transference of human consciousness and identity into the virtual realm, as well as the ethical and philosophical quandaries engendered by the transfiguration of the conceptualization of the notions of mortality and the natural life cycle. The roundtable delved into the technological feasibilities and perils of engendering digital doppelgangers, the preservation of individuality after corporeal demise, as well as the plausible ramifications of the technological modification of the human essence. (shrink)

[Purposes] This paper aims to summarize the research outcome on publishing ethics of scientific journals abroad, which is expected to serve as a reference for the research on related topics in China. [Methods] Literature review method and content coding method were adopted to systematically sum up related research abroad. Then, the status quo and development trend were analyzed. [Findings] There are five main research topics: anomy of publishing ethics, elements of publishing ethics (...) norms, status quo of publishing ethics implementation, knowledge of authors and editors on publishing ethics and their attitudes, and management of publishing ethics. [Conclusions] Foreign research on publishing ethics of scientific journals has achieved fruitful results with obvious characteristics, but there is a lack of research scope definition and systematic analysis of ethical norms. Chinese scientific journals should take international research outcome as a reference and strengthen the research on ethical norms to enhance the development of publishing ethics. (shrink)

Even if the “value-free ideal of science” (VFI) were an unattainable goal, one could ask: can it be a useful fiction, one that is beneficial for the research community and society? This question is particularly crucial for scholars and institutions concerned with research integrity (RI), as one cannot offer normative guidance to researchers without making some assumptions about what ideal scientific research looks like. Despite the insofar little interaction between scholars studying RI and those working on values (...) in science, the overlap of topics and interests make collaboration between the two fields promising for understanding research and its ethics. Here, we identify—for the use of RI scholars—the non-epistemic reasons (societal, political, professional) for and against the VFI considered in the literature. All of these are concerned with the beneficial or detrimental consequences that endorsing the VFI would have on society, policy-making, or the scientific community, with some authors appealing to the same principles to argue for opposite positions. Though most of the reviewed articles do not endorse the VFI, it is generally agreed that some constraints have to be put on the use of non-epistemic values. Disagreement on the utility of the VFI lies both on the different epistemic-descriptive positions taken by different authors, and on the scarcity of relevant empirical studies. Engaging critically with the reasons here identified and more in general with the values in science debate will help the RI community decide whether the VFI should be included in future codes of conduct. (shrink)

The history of the regulation of animal research is essentially the history of the emergence of meaningful social ethics for animals in society. Initially, animal ethics concerned itself solely with cruelty, but this was seen as inadequate to late 20th-century concerns about animal use. The new social ethic for animals was quite different, and its conceptual bases are explored in this paper. The Animal Welfare Act of 1966 represented a very minimal and in many ways incoherent attempt (...) to regulate animal research, and is far from morally adequate. The 1985 amendments did much to render coherent the ethic for laboratory animals, but these standards were still inadequate in many ways, as enumerated here. The philosophy underlying these laws is explained, their main provisions are explored, and future directions that could move the ethic forward and further rationalize the laws are sketched. (shrink)

COVID-19 vaccination of children has begun in various high-income countries with regulatory approval and general public support, but largely without careful ethical consideration. This trend is expected to extend to other COVID-19 vaccines and lower ages as clinical trials progress. This paper provides an ethical analysis of COVID-19 vaccination of healthy children. Specifically, we argue that it is currently unclear whether routine COVID-19 vaccination of healthy children is ethically justified in most contexts, given the minimal direct benefit that COVID-19 vaccination (...) provides to children, the potential for rare risks to outweigh these benefits and undermine vaccine confidence, and substantial evidence that COVID-19 vaccination confers adequate protection to risk groups, such as older adults, without the need to vaccinate healthy children. We conclude that child COVID-19 vaccination in wealthy communities before adults in poor communities worldwide is ethically unacceptable and consider how policy deliberations might evolve in light of future developments. (shrink)

The purpose of this article is to show that animal rights are not necessarily at odds with the use of animals for research. If animals hold basic moral rights similar to those of humans, then we should consequently extend the ethical requirements guiding research with humans to research with animals. The article spells out how this can be done in practice by applying the seven requirements for ethical research with humans proposed by Ezekiel Emanuel, David Wendler (...) and Christine Grady to animal research. These requirements are i) social value, ii) scientific validity, iii) independent review, iv) fair subject selection, v) favorable risk-benefit ratio, vi) informed consent, and vii) respect for research subjects. In practice, this means that we must reform the practice of animal research to make it more similar to research with humans, rather than completely abolish the former. Indeed, if we banned animal research altogether, then we would also deprive animals of its potential benefits – which would be ethically problematic. (shrink)

The process of deciding which books academics submit should be published favors authors who are associated with the most prestigious universities and other research institutions. Some feel this bias could be minimized if the review of academic books were carried out as anonymously as is the review of articles for journal publication. Not likely to happen soon, however, because both academic and publishing industries promote the hierarchy of perceived excellence that permeates the process of publishing academic books. (...) To find this process to be in any way unethical one needs to move beyond individual-oriented approaches and adopt a social perspective that fosters fundamental fairness, equal opportunity, and equal respect. Here I assume these values as I focus on pre-publication of philosophical work in the United States. (shrink)

Research on the ethics of algorithms has grown substantially over the past decade. Alongside the exponential development and application of machine learning algorithms, new ethical problems and solutions relating to their ubiquitous use in society have been proposed. This article builds on a review of the ethics of algorithms published in 2016, 2016). The goals are to contribute to the debate on the identification and analysis of the ethical implications of algorithms, to provide an updated analysis (...) of epistemic and normative concerns, and to offer actionable guidance for the governance of the design, development and deployment of algorithms. (shrink)

The Human Genome Project is regarded by many as one of the major scientific achievements in recent science history, a large-scale endeavour that is changing the way in which biomedical research is done and expected, moreover, to yield considerable benefit for society. Thus, since the completion of the human genome sequencing effort, a debate has emerged over the question whether this effort merits to be awarded a Nobel Prize and if so, who should be the one to receive it, (...) as no more than three individuals can be selected. In this article, the HGP is taken as a case study to consider the ethical question to what extent it is still possible, in an era of big science, of large-scale consortia and global team work, to acknowledge and reward individual contributions to important breakthroughs in biomedical fields. Is it still viable to single out individuals for their decisive contributions in order to reward them in a fair and convincing way? Whereas the concept of the Nobel prize as such seems to reflect an archetypical view of scientists as solitary researchers who, at a certain point in their careers, make their one decisive discovery, this vision has proven to be problematic from the very outset. Already during the first decade of the Nobel era, Ivan Pavlov was denied the Prize several times before finally receiving it, on the basis of the argument that he had been active as a research manager rather than as a researcher himself. The question then is whether, in the case of the HGP, a research effort that involved the contributions of hundreds or even thousands of researchers worldwide, it is still possible to “individualise” the Prize? The “HGP Nobel Prize problem” is regarded as an exemplary issue in current research ethics, highlighting a number of quandaries and trends involved in contemporary life science research practices more broadly. (shrink)

In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea.

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of (...) the European Union.The most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trialswere the least common ethical policies. Three aspects were significantly morecommon in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation.On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences amongbiomedical journals’ ethical policies calls for further research and active measuresto harmonize policies across journals. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

AI systems that demonstrate significant bias or lower than claimed accuracy, and resulting in individual and societal harms, continue to be reported. Such reports beg the question as to why such systems continue to be funded, developed and deployed despite the many published ethical AI principles. This paper focusses on the funding processes for AI research grants which we have identified as a gap in the current range of ethical AI solutions such as AI procurement guidelines, AI impact assessments (...) and AI audit frameworks. We highlight the responsibilities of funding bodies to ensure investment is channelled towards trustworthy and safe AI systems and provides case studies as to how other ethical funding principles are managed. We offer a first sight of two proposals for funding bodies to consider regarding procedures they can employ. The first proposal is for the inclusion of a Trustworthy AI Statement’ section in the grant application form and offers an example of the associated guidance. The second proposal outlines the wider management requirements of a funding body for the ethical review and monitoring of funded projects to ensure adherence to the proposed ethical strategies in the applicants Trustworthy AI Statement. The anticipated outcome for such proposals being employed would be to create a ‘stop and think’ section during the project planning and application procedure requiring applicants to implement the methods for the ethically aligned design of AI. In essence it asks funders to send the message “if you want the money, then build trustworthy AI!”. (shrink)

Ethics committees like Institutional Review Boards and Research Ethics Committees are typically empowered to approve or reject proposed studies, typically conditional on certain conditions or revisions being met. While some have argued this power should be primarily a function of applying clear, codified requirements, most institutions and legal regimes allow discretion for IRBs to ethically evaluate studies, such as to ensure a favourable risk-benefit ratio, fair subject selection, adequate informed consent, and so forth. As a result, (...) ethics committees typically make moral demands on researchers: require them to act in a way the committee considers ethically right or appropriate. This paper argues that moral demands are legitimate only if publicly justifiable; and as a result, committee decisions are subject to a public justification requirement. Ethics committees can permissibly request for more information, changes to the research protocol or that the research is delayed or even stopped only if these demands are publicly justifiable. This latter claim is in turn justified on the basis that moral demands to φ are permissible only if we are in a position to know that the addressee ought to φ and that we are in a position to know a proposition only if it is publicly justifiable. This argument suggests that ethics committees must consciously and explicitly appeal to public reasons in their decision-making. In cases where public reasons cannot be offered, committees would not be permitted to reject a given study or make approval conditional on an amendment. (shrink)