Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Rosamond Rhodes calls for a reconceptualization of research ethics and a fundamental shift in attitude toward both research subjects and scientific investigators. She recognizes the limits of the e...

We whole-heartedly support Andrew Garland, Stephanie Morain, and Jeremy Sugarman’s claim that clinicians have a duty to participate in pragmatic clinical trials (Garland, Morain, and Sugarman 2023)...

In this chapter, the focus is on robotics development and its ethical implications, especially on some particular applications or interaction principles. In recent years, such developments have happened very quickly, based on the advances achieved in the last few decades in industrial robotics. The technological developments in manufacturing, with the implementation of Industry 4.0 strategies in most industrialized countries, and the dissemination of production strategies into services and health sectors, enabled robotics to develop in a variety of new directions. Policy (...) making and ethical awareness addressed these issues using socio-economic knowledge and also in an effort to solve some of the application problems raised in a range of different circumstances and sectoral environments. (shrink)

Since the inception of large‐scale human genome research, there has been much caution about the risks of exacerbating a number of socially dangerous attitudes linked to human genetics. These attitudes are usually labeled with one of a family of genetic or genomic “isms” or “ations” such as “genetic essentialism,” “genetic determinism,” “genetic reductionism,” “geneticization,” “genetic stigmatization,” and “genetic discrimination.” The psychosocial processes these terms refer to are taken to exacerbate several ills that are similarly labeled, from medical racism and psychological (...) fatalism to economic exploitation and social exclusion. But as genomic information becomes more familiar in clinical and research settings as well as other life activities, do we need to continue to worry so much about this family of attitudes and their impact on existing problems?In genomics, the underlying anxiety has been that disclosure of genomic information will trigger a series of (seemingly unavoidable) negative responses that will affect individuals, their families, and their communities at large. The fundamental social challenges that hyperbolic genomic messaging, low genomic literacy, and “folk biology” help sustain remain to be addressed. If we hope to break the cycle of genomic isms and ations, we will have to get better at resisting overinterpretations of the relevance that genomics has for people’s future potentials, ancestral vulnerabilities, community memberships, and ethnic affiliations. (shrink)

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and (...) commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it. (shrink)

The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole (...) exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. (shrink)

This paper makes a plea for more reflexive attempts to develop and anchor the emerging concept of responsible research and innovation. RRI has recently emerged as a buzzword in science policy, becoming a focus of concerted experimentation in many academic circles. Its performative capacity means that it is able to mobilise resources and spaces despite no common understanding of what it is or should be ‘made of’. In order to support reflection and practice amongst those who are interested in and (...) using the concept, this paper unpacks understandings of RRI across a multi-disciplinary body of peer-reviewed literature. Our analysis focuses on three key dimensions of RRI that remain particularly opaque. A total of 48 publications were selected through a systematic literature search and their content was qualitatively analysed. Across the literature, RRI is portrayed as a concept that embeds numerous features of existing approaches to govern and assess emerging technologies. Our analysis suggests that its greatest potential may be in its ability to unify and provide political momentum to a wide range of long-articulated ethical and policy issues. At the same time, RRI’s dynamism and resulting complexity may represent its greatest challenge. Further clarification on what RRI has to offer in practice—beyond what has been offered to date—is still needed, as well as more explicit engagement with research and institutional cultures of responsibility. Such work may help to realise the high political expectations that are attached to nascent RRI. (shrink)

Several years ago, the University of Minnesota hosted a lecture by Alan Milstein, a Philadelphia attorney specializing in clinical trial litigation. Milstein, who does not mince words, insisted on calling research studies “experiments.” “Don't call it a study,” Milstein said. “Don't call it a clinical trial. Call it what it is. It's an experiment.” Milstein's comments made me wonder: when was the last time I heard an ongoing research study described as a “human experiment”? The phrase is now almost always (...) associated with abuses. Asking a prospective subject to sign up for a medical experiment would probably get roughly the same response as asking him or her to sign up for a police interrogation. It wasn't always this way. In the early days of American bioethics, scholars used the word “experimentation” in the same neutral way that they later began to use “research study” and “clinical trial.”. (shrink)

Bioethicists have typically disdained where they did not simply ignore the Hippocratic tradition in medicine. Its exclusivity—an oath of and for physicians—seemed contrary to the perspective that bioethicists have attempted to invoke. Robert M. Veatch recently articulated this rejection of the Hippocratic tradition, and of a professional ethic of medicine in general, in a volume based on his Gifford lectures. Here that argument is critiqued. The strengths of the Hippocratic tradition as a flexible and ethical social doctrine are offered in (...) its stead. (shrink)

Several feminist philosophers of science have argued that social and political values are compatible with, and may even enhance, scientific objectivity. A variety of normative recommendations have emerged regarding how to identify, manage, and critically evaluate social values in science. In particular, several feminist theorists have argued that scientific communities ought to: 1) include researchers with diverse experiences, interests, and values, with equal opportunity and authority to scrutinize research; 2) investigate or "study up" scientific phenomena from the perspectives, interests, and (...) conditions of marginalized stakeholders potentially affected by the research; and 3) make gender, ethnicity, class, and geographical location "visible," or use them as categories of analysis when appropriate. Yet, more work is needed to determine what exactly these recommendations would require, and the benefits they would yield, in specific research contexts. Using the recent development of the human papillomavirus (HPV) vaccines, we examine how these three feminist recommendations would have applied. We argue that these principles would have yielded several epistemic and social benefits in the HPV case, as well as in biomedical research more generally. That is, biomedical research guided by these principles would not only be epistemically superior, but also more socially responsible. (shrink)

These CQ Sources were compiled by Bette Anton.

BackgroundThe COVID-19 pandemic has presented extraordinary challenges to worldwide healthcare systems, however, prevalence remains low in some countries. While the challenges of conducting research in high-prevalence countries are well published, there is a paucity from low COVID-19 countries.MethodsA PRISMA guided systematic review was conducted using the databases Ovid-Medline, Embase, Scopus and Web of Science to identify relevant articles discussing ethical issues relating to research in low prevalence COVID-19 countries.ResultsThe search yielded 133 original articles of which only 2 fit the inclusion (...) criteria and aim, with neither specific to low prevalence. Most of the available literature focused on clinical management and resource allocation related to high prevalence countries. These results will be discussed under the ethical dimensions of equity, individual liberty, privacy and confidentiality, proportionality, public protection, provision of care, reciprocity, stewardship and trust..ConclusionsA systematic review failed to identify articles relating to COVID-19 research ethics, specific to low prevalence countries. It shows that there is a significant gap in the literature that warrants further investigation. Common ethical principles were used to present a distinct set of challenges experienced by a country with a low prevalence of COVID-19. This unique perspective of some of the common ethical problems surrounding research, may help guide further discussion and guide research in similar countries. (shrink)

Because of the important benefits that biomedical research offers to humans, some have argued that people have a general moral obligation to participate in research. Although the defense of such a putative moral duty has raised controversy, few scholars, on either side of the debate, have attended to the social context in which research takes place and where such an obligation will be discharged. By reflecting on the social context in which a presumed duty to participate in research will obtain, (...) this article shows that decontextualized discussions of this putative moral obligation are problematic. (shrink)

Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups (...) for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants. (shrink)

Like many trained in philosophy, we greatly value the work of those scholars with the courage to espouse contrarian views, particularly when the ideas in dispute lie at the very heart of entrenched...

The proper role, if any, for religion-based arguments is a live and sometimes heated issue within the field of bioethics. The issue attracts heat primarily because bioethical analyses influence the outcomes of controversial court cases and help shape legislation in sensitive biopolicy areas. A problem for religious bioethicists who seek to influence biopolicy is that there is now widespread academic and public acceptance, at least within liberal democracies, that the state should not base its policies on any particular religion’s metaphysical (...) claims or esoteric moral system. In response, bioethicists motivated by religious concerns have adopted two identifiable strategies. Sometimes they rely on slippery-slope arguments that, sometimes at least, have empirically testable premises. A more questionable response is the manipulation and misuse of secular-sounding moral language, such as references to “human dignity,” and the plights of groups of people labeled “vulnerable.”. (shrink)

Some jurisdictions that have decriminalized assisted dying exclude psychiatric patients on the grounds that their condition cannot be determined to be irremediable, that they are vulnerable and in need of protection, or that they cannot be determined to be competent. We review each of these claims and find that none have been sufficiently well-supported to justify the differential treatment psychiatric patients experience with respect to assisted dying. We find bans on psychiatric patients’ access to this service amount to arbitrary discrimination. (...) Proponents of banning the practice ignore or overlook alternatives to their proposal, like an assisted dying regime with additional safeguards. Some authors have further criticized assisted dying for psychiatric patients by highlighting allegedly problematic practices in those countries which allow it. We address recent evidence from the Netherlands, showing that these problems are either misrepresented or have straightforward solutions. Even if one finds such evidence troubling despite our analysis, other jurisdictions need not adopt every feature of the Dutch system. (shrink)

In biomedical research lack of trust is seen as a great threat that can severely jeopardise the whole biomedical research enterprise. Practices, such as informed consent, and also the administrative and regulatory oversight of research in the form of research ethics committees and Institutional Review Boards, are established to ensure the protection of future research subjects and, at the same time, restore public trust in biomedical research. Empirical research also testifies to the role of trust as one of the decisive (...) factors in research participation and lack of trust as a barrier for consenting to research. However, what is often missing is a clear definition of trust. This paper seeks to address this gap. It starts with a conceptual analysis of the term trust. It compares trust with two other related terms, those of reliance and trustworthiness, and offers a defence of Baier’s attribute of ‘good will’ a basic characteristic of trust. It, then, proceeds to consider trust in the context of biomedical research by examining two questions: First, is trust necessary in biomedical research?; and second, do increases in regulatory oversight of biomedical research also increase trust in the field? This paper argues that regulatory oversight is important for increasing reliance in biomedical research, but it does not improve trust, which remains important for biomedical research. It finishes by pointing at professional integrity as a way of promoting trust and trustworthiness in this field. (shrink)

The clinical introduction of medical devices often occurs with relatively little oversight, regulation and (long-term) follow-up. Some recent controversies underscore the weaknesses of the current regime, such as the complications surrounding the metal-on-metal hip implants and the scandal surrounding the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. The absence of national registries hampered the collection of reliable information on the risks and harms of the PIP breast implants. To warrant long-term safety, a (...) case can be made for mandatory post-marketing surveillance by means of the establishment of compulsory registries. In this edition of Public Health Ethics, Schofield calls for debate on how such a registry system should be initiated and maintained and how it would relate to the ethical requirement of consent. Here we use breast implant registries as a case to discuss whether and when a so-called ‘thick opt-out’ would be an appropriate method to include people in medical device registries. We conclude that a thick opt-out procedure for medical device registries is only justifiable in cases where inclusion does not involve burdens (or very low), when it does not involve a sensitive subject and when the data are stored anonymously (or at least not directly linked to the medical record). Otherwise, inclusion should be sought by means of an opt-in. (shrink)

This essay explores the claim that bioethics has become a mode of biopolitics. It seeks to illuminate one of the myriad of ways that bioethics joins other institutionalized discursive practices in the task of producing, organizing, and managing the bodies—of policing and controlling populations—in order to empower larger institutional agents. The focus of this analysis is the contemporary practice of transnational biomedical research. The analysis is catalyzed by the enormous transformation in the political economy of transnational research that has occurred (...) over the past three decades and the accompanying increase in the numbers of human bodies now subjected to research. This essay uses the work of Michel Foucault, particularly his notion of docile bodies, to analyze these changes. Two loci from the bioethics literature are explored—one treating research in the United States and one treating research in developing countries. In the latter, we see a novel dynamic of the new biopolitics: the ways in which bioethics helps to create docile political bodies that will police themselves and who will, in turn, facilitate the production of docile human bodies for research. (shrink)

In this paper I argue for recognizing the moral duty to participate in research. I base my argument on the need for biomedical research and the fact that at some point studies require human participants, what I call collaborative necessity. In presenting my position, I argue against the widely accepted views of Han Jonas and all of those who have accepted his declarations without challenge. I go on to show why it is both just and fair to invite and encourage (...) people to participate in studies. It is just because research participation is the necessary means to achieve the broadly shared goals of preventing and curing disease and alleviating disease symptoms. Mutual love requires us to be willing to do for others what we would want them to do for us. It is fair because the approach treats similarly situated people in the same way. Research participation is morally required because failing to do one's part in the collaborative project of advancing biomedical science would be free-riding. People who exempt themselves from participation while eagerly accepting benefits from others doing their part are taking advantage of their compatriots and treating themselves as more deserving than others when they are not. (shrink)

New health technologies are rapidly emerging from various areas of bioscience research, such as gene editing, regenerative medicine and synthetic biology. These technologies raise promising medical possibilities but also a range of ethical considerations. Apart from the issues involved in considering whether novel health technologies can or should become part of mainstream medical treatment once established, the process of research translation to develop such therapies itself entails particular ethical concerns. In this paper I use synthetic biology as an example of (...) a new and largely unexplored area of health technology to consider the ways in which novel health technologies are likely to emerge and the ethical challenges these will present. I argue that such developments require us to rethink conventional attitudes towards clinical research, the roles of doctors/researchers and patients/participants with respect to research, and the relationship between science and society; and that a broader framework is required to address the plurality of stakeholder roles and interests involved in the development of treatments based on novel technologies. (shrink)

After describing Heidegger's critique of metaphysics as ontotheology, I unpack the metaphysical assumptions of several transhumanist philosophers. I claim that they deploy an ontology of power and that they also deploy a kind of theology, as Heidegger meant it. I also describe the way in which this metaphysics begets its own politics and ethics. In order to transcend the human condition, they must transgress the human.

Medical Research Council, Capetown, South Africa Nasheen Naidoo Medical Research Council, Capetown, South Africa Shamagonam James Medical Research Council, Durban, South Africa Priscilla Reddy Medical Research Council, Capetown, South Africa * Corresponding author: 306 Arnold House, School of Public Health & Health Sciences, University of Massachusetts, Amherst, MA 01003, USA. Tel.: (413) 545 1005; Email: Buchanan{at}schoolph.umass.edu ' + u + '@' + d + ' '//--> . Abstract The analysis presented here lays out the ethical warrants for requiring community oversight (...) of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of health research is justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. CiteULike Connotea Del.icio.us What's this? (shrink)

This article challenges the importance and necessity of confidentiality, which are often taken for granted, and questions whether the default promise of confidentiality to all participants, particularly in educational research, could in fact be an unnecessary concern. This article begins by reviewing the difference in the way confidentiality is handled in different fields and the applicability of some underlying assumptions. This is followed by an explanation of why confidentiality is investigated in the sense of anonymity in this article. Then the (...) article draws on an empirical study where original researchers and their original participants were interviewed about their views on anonymity. Lastly, the contradiction between the promises of confidentiality and the recognition of a participant’s contribution is highlighted. The article concludes with a call for more empirical observation and investigation into the importance of confidentiality. (shrink)

Volume 24, Issue 10, October 2024, Page 72-76.

Beneficence is one of the four principles that form the basis of the Australian National Statement. The aim of this paper is to explore the philosophical development of this principle and to clarify the role that beneficence plays in contemporary discussions about human research ethics. By examining the way that guidance documents, particularly the National Statement, treats beneficence we offer guidance to researchers and human research ethics committee members on the practical application of what can be a conceptually difficult principle.

Rosamond Rhodes' evaluation of modern American research ethics emphasizes a need to shift from a protectionist understanding of human subjects to one that focuses more on the conduct of research in...

In discussions about direct-to-consumer availability of genetic testing, much attention has been given to identifying the various risks and benefits that individuals might incur. For example, upon...

The featured case discussion on the role of consent and individual autonomy in the PIP breast implant scandal raises interesting and important questions regarding the right of patients (and individuals in general) to decide whether to have their personal data included in medical registries and used for research. The fate of the National Breast Implant Registry, following the introduction of a policy that demanded formally recorded informed consent, is particularly enlightening. Combined with the (ex post) fact that reliable and comprehensive (...) data would have been useful in this specific case, it clearly illustrates the dangers of overemphasizing individual autonomy in observational research. The issue is timely, as the European Commission has recently proposed a new Data Protection Regulation (European Commission, 2012) that may have serious implications for registry based research. In this commentary, I will first discuss two aspects of the regulatory framework that arguably contribute to the problematic situation and then offer an alternative view on why requiring consent should not be the default position in this kind of research. (shrink)

In "Rethinking Research Ethics," Rosamond Rhodes argues that everyone has a responsibility to participate in research ethics programs (Rhodes 2005). After discussing the moral underpinnings upon which such a claim might rest, this article brings up two concerns in response to Rhodes' claim. The first worry is pragmatic: Rhodes argues that the focus in research ethics should be on the hypothetical consent of idealized moral agents, an approach that is constrained by practical considerations. The second objection is that, in most (...) research studies, participants are paid, which undermines the accusation of free-riding for non-participants. (shrink)