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)

Critics of Institutional Review Board (IRB) practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the institutional Reviw boardsocial and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical model", the point (...) of contemporary human research subjects regulation remains the same across all domains of research. That point is to protect the autonomy of human subjects, primarily through the use of informed consent. In fields as different as biomedical self-experimentation and ethnography there is the danger of losing sight of subjects' autonomy. Critiques of the so-called medical model are sometimes libertarian and sometimes utilitarian in spirit. Either way, such critiques have not yet demonstrated that these philosophical schools of thought have the resources to guard against the potential risk of harm that lexically prioritizing the autonomy of human subjects does. Precisely because IRB review recognizes that human subjects research occurs in different fields using different research methods, IRB review requires researchers to explain their particular methods, the particular risks of harm created by these methods, and the implementation of procedures by which subjects may autonomously consent to precisely those risks. (shrink)

The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process (...) of international guidelines for biomedical research involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (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 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)

In various writings Michel Foucault has shown how, in the beginning of the 19th century, in settings such as army barracks, psychiatric hospitals and penitentiary institutions, the modern human sciences were ‹born› as an ensemble of disciplines (medical biology, psychiatry, psychology, criminology, and the like) From the beginning, the nature-nurture de- bate has been one of its key disputes. Are human individuals malleable by environmental factors (such as psychiatric treatments or disciplinary regimes), or do they rather display inborn (...) predispositions for delin- quency and other forms of antisocial behaviour? In the current era of genetic testing, in behavioural genomics and neuroscience, this issue is as controversial and topical as ever. Büchner’s unfinished drama Woyzeck (written in 1836) is a remarkable anticipation of this debate, staging the birth of the human individual as a research subject. It is the story of a destitute soldier who, according to his superiors, displays er- rant behaviour and is therefore recruited to serve as a research subject in an experiment. His army physician turns him into a ‹case›, which can be meticulously monitored and studied so as to record the genesis of a crime. In this paper, Büchner’s unsettling play is analysed in detail as one of the great anticipatory literary documents of the 19th century, ex- ploring the idea of predictive psychiatry and the quest for genetic pre- dispositions: a primal scene as it were of the nature-nurture debate as it unfolds from predictive criminology up to behavioural genomics. (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)

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)

Human-sciences research often focuses on social problems to create tools for solving them. Yet, in using common prejudices in gathering and sorting data on their subjects, they risk propagating those same prejudices. This article proposes that a major subject matter of human sciences is human concepts themselves. Concepts about “what we are,” individually and as a species, are deeply embedded, if not essential. It concludes that for greater precision, practitioners in human sciences must take (...) maximum advantage of this characteristic of the subject, making individuals’ concepts about what they consider themselves to be integral criteria of data gathering and sorting. (shrink)

The right to withdraw from participation in research is recognized in virtually all national and international guidelines for research on human subjects. It is therefore surprising that there has been little justification for that right in the literature. We argue that the right to withdraw should protect research participants from information imbalance, inability to hedge, inherent uncertainty, and untoward bodily invasion, and it serves to bolster public trust in the research enterprise. Although this argument (...) is not radical, it provides a useful way to determine how the right should be applied in various cases. (shrink)

Tobias-Renstrøm and Køppe (2020) show the several conceptual limits that new materialism and postmodern subject models have for psychological theory and research. The present study continues in this discussion and argues that the applicability of the ideas of quantum-inspired new materialism depends on the theoretical perspectives that we consider for analysis: be it the first-person perspective referring to the subjective experience of a human subject, or the third-person perspective, in which a human subject is observed by an (...) external observer. While the arguments of new materialism are in accordance with the analysis of the act of observation performed by an external observer, some problems arise when trying to theoretically approach the first-person subjective experience of a human subject. For example, new materialism fails to explain why human minds can maintain the awareness of a subject’s identity throughout their lives and to recall the memories about their past personal experiences. (shrink)

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent-undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. (...) By contrast, coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

A wide variety of scientific research projects include public participation in roles going beyond the classic use of subjects in human subjects research. “Participatory research” is an umbrella term for such projects. In this chapter, we begin by surveying the variety of participatory research approaches across fields. We examine what goals participatory research projects seek to achieve, both of social and scientific value. Next, we apply this theoretical framework to challenges that participatory (...) research faces. We then survey three typologies of participatory research projects, each of which can illuminate and guide decisions in project development. We end with a look at participatory research approaches in health contexts, applying the theoretical resources we introduced earlier in the chapter. (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)

Introduction In 2013, Dr. J. Muizelaar and Dr. R. Schrot, two neurosurgeons at the University of California Davis Medical Center (UCDMC), were found guilty of research misconduct due to failure to comply with institutional policies as well as Food and Drug Administration (FDA) regulations governing human subjects research. At issue here, however, is the difference between research and innovative therapy in the clinical setting of patient care where clinical judgment is reasonably to be privileged. Methods (...) The UCDMC investigative document is reviewed along with standard literature on clinical ethics and clinical data about glioblastoma multiforme (GBM) cancer. Results In this paper I argue that, by tendentiously focusing on policies, regulations, and procedures governing human subjects research, the UCDMC investigation failed to account for the centrality of clinical judgment and clinical ethics pertinent to judicious review of this matter, especially given the unique clinical context of terminally ill patients having exhausted standard care treatment options for glioblastoma multiforme (GBM) cancer. Conclusions The UCDMC investigation raises serious problems for clinicians who are engaged in innovative therapy in the clinical setting, requiring a regulatory framework separate from the normal Institutional Review Board (IRB) process. (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)

Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do otherwise is essentially viewed as violation of the human research subject’s legal and moral rights. However, with the recent philosophical concerns about responsible robotics, the limits and ambiguities (...) of research-subjects ethical codes become apparent on the matter of constructing automata that maximally resemble human beings (as defined hereunder). In this case, the automata themselves, as products of research and development, are in the very process of their construction subjects of research and development. However, such research faces a paradox: The subjects cannot give their informed consent to this research for their own development, although their consent would be needed for the research. According to ethical codes, this research would be unethical. The article then explores whether the background concepts giving rise to this paradox could be reframed in order to allow such research to proceed ethically. (shrink)

Canada’s Tri-Council Policy Statement: Ethical conduct for research involving humans, first published in 1998, has recently been updated.1 The US Department of Health and Human Services has just issued an Advance Notice of Proposed Rulemaking that would substantially change the 20-year-old Common Rule governing most federally funded research involving human participants.2 A comparison of the two countries’ systems for protecting human research participants is therefore timely. This analysis situates the Canadian system in an international (...) context, with particular attention to its similarities and differences to the US system and their shared challenges going forward with their changes. (shrink)

_ Source: _Volume 5, Issue 2, pp 228 - 250 Despite inroads made by critical realism against the ‘scientific method’ in social science, the latter remains strong in subject-areas like human resource management. One argument for the alleged superiority of the scientific method lies in the taken-for-granted belief that it alone can formulate empirically testable predictions. Many of those who employ the scientific method are, however, confused about the way they understand and practice prediction. This paper takes as a (...) case study empirical research on the alleged empirical association between human resource management practices and organisational performance. By unpacking the confusion surrounding the two basic notions of prediction used, it reveals what is wrong with them, why the scientific method cannot actually make accurate predictions and why, therefore, the scientific method fails to meet its own criteria for scientificity. Finally, explanation is considered in order to prevent any confusion between it and prediction and to offer what we call _tendential prediction_. (shrink)

The goals and tasks of neuroethics formulated by Farahany and Ramos (2020) link epistemological and methodological issues with ethical and social values. The authors refer simultaneously to the social significance and scientific reliability of the BRAIN Initiative. They openly argue that neuroethics should not only examine neuroscientific research in terms of “a rigorous, reproducible, and representative neuroscience research process” as well as “explore the unique nature of the study of the human brain through accurate and representative models (...) of its function and dysfunction”, but also its responsibilities or social consequences. In our commentary, we would like to concentrate on problem selection, which is shortly noticed by Farahany and Ramos, and by BRAIN Initiative’s Neuroethics Report itself. The document raises an important issue related to problem selection, which is strengthening or perpetuating existing prejudices and biases by choosing a research subject: “scientists are prompted to consider how the questions they choose to study in the laboratory might amplify existing biases.” This leads to several further problems: what constitutes bias?; how biases may be embedded in the selection of research programs?; is it possible to conduct completely unbiased research?; who should be a gatekeeper in the case of research that may amplify biases? We try to notice possible answers to these questions in the context of the research on differences (e.g., cognitive, medical, behavioral) between human populations. (shrink)

In a recent letter, Dillion et. al (2023) make various suggestions regarding the idea of artificially intelligent systems, such as large language models, replacing human subjects in empirical moral psychology. We argue that human subjects are in various ways indispensable.

Important advances in biomedical and behavioral research ethics have occurred over the past few decades, many of them centered on identifying and eliminating significant harms to human subjects of research. Comprehensive attention has not been paid to the totality of harms experienced by animal subjects, although scientific and moral progress require explicit appraisal of these harms. Science is a public good and the prioritizing within, conduct of, generation of, and application of research must soundly (...) address questions about which research is morally defensible and valuable enough to support through funding, publication, tenure, and promotion. Likewise, educational pathways of re-imagined science are critical. (shrink)

Subjects of ectogenesis—human beings that are developing in artificial wombs (AWs)—share the same moral status as newborns. To demonstrate this, I defend two claims. First, subjects of partial ectogenesis—those that develop in utero for a time before being transferred to AWs—are newborns (in the full sense of the word). Second, subjects of complete ectogenesis—those who develop in AWs entirely—share the same moral status as newborns. To defend the first claim, I rely on Elizabeth Chloe Romanis’s distinctions (...) between fetuses, newborns and subjects of ectogenesis. For Romanis, the subject of partial ectogenesis ‘is neither a fetus nor a baby’ but is, instead, a ‘new product of human reproduction’. In this essay, I begin by, expanding upon Romanis’s argument that subjects of partial ectogenesis are not fetuses while arguing that those subjects are newborns. Next, I show that the distinction that Romanis draws between subjects of partial ectogenesis and newborns needs to be revised. The former is a kind of the latter. This leads us to an argument that shows why different moral statuses cannot be justifiably assigned to subjects of partial ectogenesis and subjects of complete ectogenesis, respectively. As subjects of partial ectogenesis share the same moral status as newborns, it follows that subjects of complete ectogenesis share the same moral status as newborns as well. I conclude by considering implications that this essay may have for the research and development of AW technology and conceptual links between a subject’s moral status and birth. (shrink)

The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a duty (...) to participate. The current social norm is that individuals participate only if they have a good reason to do so. The public goods argument implies that individuals should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making society significantly healthier and longer lived. (shrink)

This book focuses on Edmund Husserl’s philosophical collaboration with Eugen Fink which took place in the early 1930s, and shows how their disagreement over the nature, origin, and aim of phenomenology led to a crucial divergence on the issue of who was engaging in phenomenology, and with what motivation. It provides a philosophical investigation of a key moment in the development of Husserl’s late phenomenology. The author claims that Husserl’s meta-phenomenological exploration of the theoretical and, importantly, practical underpinnings of the (...) transcendental investigator leads him to affirm their humanity and, ultimately, to adopt an ethically charged ideal of “higher humanity” as telos of phenomenology. Fink argued that phenomenology was essentially an activity beyond the horizon of human possibility and history. In contrast, Džanić illustrates how Husserl was looking for a way to theoretically unite the purity of transcendental insight with the existential reality and practical motives of the phenomenologist. Understanding the complex aspects of this debate is crucial for understanding the Crisis-period of Husserl’s thought. This text appeals to graduate students and researchers in phenomenology and related fields of philosophy. (shrink)

Given the ever-present subject of consciousness wherever consciousness is, it is peculiar that consciousness researchers often mention mental states as if they are conscious independently of being the conscious states of someone [1, p. 132]. We refer to visual perceptions that become conscious, when in reality no one has ever studied mere conscious visual perceptions. What are studied are visual perceptions belonging to conscious human or animal subjects; it is the subjects who are conscious of visual stimuli, (...) not the visual perceptions. I do not know all the reasons why conscious subjects are rarely mentioned in consciousness science, but one could be pragmatic. Explaining the mysterious jump from the nonconscious nuts and bolts of neurons to the aurora borealis of consciousness is a hard problem. But it is an easy problem compared to explaining the emergence of a single conscious subject from the human brain’s 86 billion neurons [cf. 5]. Perhaps it is more practically realistic to solve the less hard problem before attempting to solve the harder hard problem. On the other hand, if we ignore a necessary condition for the presence of consciousness, our explanations of it could be plagued by inadequacy. And how can we explain our whole data set regarding consciousness if we neglect the most fundamental aspect of the data? (shrink)

Although researchers generally take great care to ensure that human subjects do not suffer very serious harms from their involvement in research, the situation is different for nonhuman animal subjects. Significant progress has been made in reducing unnecessary animal suffering in research, yet researchers still inflict severe pain and distress on tens of thousands of animals every year for scientific purposes. Some bioethicists, scientists, and animal welfare advocates argue for placing an upper limit on the (...) suffering researchers may impose on animal subjects, with rare exceptions for research that promises critical social benefits. In this article, I argue against such an upper limit on harm on the grounds that researchers often can compensate animal subjects for their suffering, even severe and long-lasting suffering. If animal subjects receive adequate compensation for the harms they suffer, then there is no general limit on how much suffering researchers may impose on them for scientific purposes. (shrink)

Gottfried Wilhelm Leibniz presents the idea of monads, as non-communicative, self-actuating system of beings that are windowless, closed, eternal, deterministic and individualistic. For him, the whole universe and its constituents are monads and that includes humans. In fact, any ‘body’, such as the ‘body’ of an animal or man has, according to Leibniz, one dominant monad which controls the others within it. This dominant monad, he often refers to as the soul. If Leibniz’s conception of monads is accepted, it merely (...) establishes human subjectivity, idiosyncrasies, biases, prejudices and individual points of view as the norm. How then do we ensure inter-subjectivity and the kind of social interaction requisite for the achievement of social order, since Leibniz’s system forecloses the possibility of interaction and communication among monads? In this essay, we argue that just as Leibniz’s monads synchronize only through the Supreme Monad (Monas Monadum), humans as social monads should also interact through a matrix of ideals like truth, honesty, sincerity, integrity, altruism, impartiality, compassion and trust. Since social order is actualised only within the context of linked social structures, relations and values, these utopian ideals would form the fulcrum through which humans relate and the very foundation that would anchor a viable social order. Our aim here is to establish a relationship between Leibniz’s metaphysics and the physical domains of life by showing that metaphysical constructs can impinge on human social relations and wellbeing. The study employed the qualitative method of research through critical analysis of texts, library and archival materials. (shrink)

What role does the wild duck play in Ibsen's famous drama? I argue that, besides mirroring the fate of the human cast members, the duck is acting as animal subject in a quasi-experiment, conducted in a private setting. Analysed from this perspective, the play allows us to discern the epistemological and ethical dimensions of the new scientific animal practice (systematic observation of animal behaviour under artificial conditions) emerging precesely at that time. Ibsen's play stages the clash between a scientific (...) and a romantic understanding of animals that still constitutes the backdrop of most contemporary debates over animals in research. Whereas the scientific understanding reduces the animal's behaviour, as well as its environment, to discrete and modifiable elements, the romantic view regards animals as being at one with (or violently disconnected from) their natural surroundings. (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)

The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually (...) exclusive sets of activities and interventions. This model is still the standard in federal regulations today. However, the Commission’s deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons. (shrink)

Many ethicists maintain that medical research on human subjects that presents no prospect of direct medical benefit must have a prospect of social benefit to be ethical. Payment is not the sort of benefit that justifies exposing subjects to risk. Alan Wertheimer has raised a serious challenge to this view, pointing out that in industry, social value is not considered necessary to make dangerous jobs ethical. This article argues that Wertheimer was correct to think that the (...) ethics of hazard pay should be the same in medical research and in business. Nevertheless, a qualified social benefit requirement should apply in both fields. For a study or a job with significant net physical risk to be ethical, it must have social value beyond the satisfaction of ordinary preferences, including the preference for money. The requirement derives from a non-absolutist version of the doctrine of double effect. If a risky study or a dangerous job has no distinctive social value, and hazard pay is subjects' or workers’ only reason to undergo risks, the very fact that they undergo risk is intended as a means to a financial end. Inviting people to enrol in such a study or to take such a job wrongfully treats people as mere means. By contrast, if a study or a job has social value, people can participate with a primary end other than money, even if they accept compensation. Researchers or employers do not intend but merely foresee risks to subjects or workers. (shrink)

This article analyzes a number of recently published autobiographies by leading participants in the Human Genome Project (HGP), in order to determine to what extent they may further our understanding of the history, scientific significance and societal impact of this major research endeavor. Notably, I will focus on three publications that fall under this heading, namely The common thread by John Sulston (2002/2003), The language of God (2006) by Francis Collins and A life decoded by Craig Venter (2007).1 (...) What may we learn from these autobiographical sources about the dynamics of scientific change? What is their added value in understanding science in general and the HGP in particular? These questions will be elaborated in three directions: on the level of knowledge (epistemology), power (politics) and the Self (ethics). On the epistemological level, genomics is often presented as a paradigm shift in the life sciences, a tremendous up-scaling of research, an “informatization” of life. Autobiographies may reveal how this shift – usually discussed in more general terms from a philosophy of science or science studies perspective – manifests itself on an individual scale, on a micro- epistemological level. On the political level, autobiographies may inform us about the micro-politics of scientific change. Finally, on the level of Self, autobiographies may allow us to analyze how researchers, through practices of Self, are actively engaged in constituting themselves as responsible subjects in the face of unpredictable dynamics and unforeseen dilemmas. (shrink)

Primarily, this article emphasises that while conducting research, especially one involving human subjects, researchers are expected to comply with applicable global and national ethical standards. Should a researcher fail to do so, he/she stands the risk of breaching research ethics, and this is capable of rendering his/her research unacceptable. Accordingly, this article, making reference to relevant ethical theories, critically examines and analyses the actions of a researcher who set out to investigate treatment recommendations for diarrhoea. (...) Ultimately, a number of ethical pitfalls in the stated research are x-rayed and some recommendations for subsequent studies are provided in this paper. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed (...) consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

The view of embodied cognition believes that cognition is embodied in nature, only the dynamics involved in the interaction between cognitive activities and the nervous system, body and environment, only by closely linking the correct evaluation of time-dependent and relationship, then only can make a correct understanding of cognitive activities. The core concepts of body and environment involved in embodied cognition are different from the body and environment in the usual sense. In terms of research methods, dynamic research (...) methods that are different from traditional computer simulations are also adopted. The article first integrates and analyzes the basic position and general propositions in the discipline, then the embodied cognition are explained based on author's understanding. In addition, the suitability of dynamic research methods, its advantages and disadvantages is analyzed, and finally, a brief summary of the current status of embodied cognition research. (shrink)

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

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)

This issue of Technoetic Arts: A Journal of Speculative Research (TA) encompasses eight articles by artists and scholars from around the globe who engage with methodologies of art practice within research that reflects on technological and ecological change, contributing to the discourse on the inclusion of subjective experience in research. The articles by authors Dulmini Perera, Kate Doyle, Nora S. Vaage, Merete Lie, Nikita Peresin Meden, Kristina Pranjić, Peter Purg, Nicolaas H. Jacobs, Marth Munro, Chris Broodryk, Semi (...) Ryu, Rahul Mahata, Doreswamy, Sana Altaf and Aqib Javid Parry form a collection that crosses disciplines and genres to engage in fundamental critique of existing modes of enquiry and conclusion. The texts situate art and design methodologies in particular cultural contexts and in relation to frameworks defined by research methodologies of the sciences and humanities to gain agency for critique and to counter a sense of inevitability that has come to mark the most recent crises. (shrink)

This paper addresses several questions related to the nature, production, and use of animal-human (a-h) chimeras. At the heart of the issue is whether certain types of a-h chimeras should be brought into existence, and, if they are, how we should treat such creatures. In our current research environment, we recognize a dichotomy between research involving nonhuman animal subjects and research involving human subjects, and the classification of a research protocol into one (...) of these categories will trigger different ethical standards as to the moral permissibility of the research in question. Are a-h chimeras entitled to the more restrictive and protective ethical standards applied to human research subjects? We elucidate an Aristotelian-Thomistic metaphysical framework in which to argue how such chimeras ought to be defined ontologically. We then examine when the creation of, and experimentation upon, certain types of a-h chimeras may be morally permissible. (shrink)

The present paper aims to validate our research on human–humanoid interaction (HHI) using the minimalist humanoid robot Telenoid. We conducted the human–robot interaction test with 142 young people who had no prior interaction experience with this robot. The main goal is the analysis of the two social dimensions (‘‘Perception’’ and ‘‘Believability’’) useful for increasing the natural behaviour between users and Telenoid.Weadministered our custom questionnaire to human subjects in association with a well defined experimental setting (‘‘ordinary (...) and goal-guided task’’). A thorough analysis of the questionnaires has been carried out and reliability and internal consistency in correlation between the multiple items has been calculated. Our experimental results show that the perceptual behaviour and believability, as implicit social competences, could improve the meaningfulness and the natural-like sense of human–humanoid interaction in everyday life task-driven activities. Telenoid is perceived as an autonomous cooperative agent for a shared environment by human beings. (shrink)

The human mind has been a subject matter of study in psychology, law, science, philosophy and other disciplines. By definition, its potential is power, abilities and capacities including perception, knowledge, sensation, memory, belief, imagination, emotion, mood, appetite, intention, and action (Pardo, Patterson). In terms of role, it creates and shapes societal morality, culture, peace and democracy. Today, a rapidly advancing science–technology–artificial intelligence (AI) landscape is able to reach into the inner realms of the human mind. Technology, particularly neurotechnology (...) enables access to the human mind for research, treatment and other purposes. This enabling feature is now a growing concern. In the field of human rights, this human-science–technology interface is leading to articulation of new human rights to safeguard against modern threats. The wider usage of expressions like neurolaw and mental autonomy reflects on the emerging field of standards to protect the human mind from interference, manipulation and control. Growing literature on the subject sheds light on the human-rights-based approach to the challenge. (shrink)

Although patterns of human activity show a large degree of freedom, they exhibit structural patterns subjected by geographic and social constraints. Aiming at various problems of personalized recommendation in mobile networks, a social network recommendation algorithm is proposed with a variety of context-aware information and combined with a series of social network analysis methods.Based on geographical location and temporal information, potential social relations among users are mined deeply to find the most similar set of users for the target user, (...) then recommendations are carried out incorporating with social relations of the mobile users to effectively solve the problem of recommendation precision. The above study can not only help LBSN designers and developers to better understand their users and grasp their want, but also help to refine the design of their system to provide users with more appropriate applications and services.The experimental results on the real-world dataset verify the feasibility and effectiveness of the proposed algorithm, and it has higher prediction accuracy compared with existing recommendation algorithms. (shrink)

Modern society faces major environmental problems, but there are many difficulties in studying the nature–human relationship from an integral psychosocial perspective. We propose the ecomind sponge conceptual framework, based on the mindsponge theory of information processing. We present a systematic method to examine the nature–human relationship with conceptual frameworks of system boundaries, selective exchange, and adaptive optimization. The theoretical mechanisms were constructed based on principles and new evidence in natural sciences. The core mechanism of ecomindsponge is the subjective (...) sphere of influence, which is the limited mental representation of information received from and processed based on the objective sphere of influence–actual interactions in reality. The subjective sphere is the sum of two sub-spheres: influencing (proactive) and being influenced (reactive). Maladaptation in thinking and behavior of the mind as an information collection-cum-processor results from the deviation of the subjective sphere from reality, which includes two main types: “stupidity” and “delusion”. Using Bayesian Mindsponge Framework (BMF) analytics on a dataset of 535 urban residents, we provide consistent statistical evidence on the proposed properties of subjective spheres. The dynamic framework of ecomindsponge can be used flexibly and practically for environmental research as well as other psychosocial fields. (shrink)

For centuries, philosophers studying the great mysteries of human subjectivity have focused on the mind/body problem and the difference between human beings and animals. Now a new ontological question takes center stage: to what extent can a manufactured object (a computer) exhibit qualities of mind? There have been passionate exchanges between those who believe that a "manufactured mind" is possible and those who believe that mind cannot exist except as a living, socially situated, embodied person. As with earlier (...) arguments, this one shows no sign of being resolved. But the fight over computationalism (the belief that all mental processes can be generated by computer programs) has immediate, "hard" consequences for technological research and development, social- and cognitive-science methodology, and for our everyday experience of the world and ourselves. This special issue consists of papers presented at a conference of the same title held at the Center for Cognitive Science at the University at Buffalo, 22-23 May 1990. The authors come from a variety of disciplinary backgrounds (Computer Science, Linguistics, Philosophy, Psychology, Sociology, etc.), and bring a wide variety of perspectives to the topic. (shrink)

Rival causal and interpretive approaches to explaining social phenomena have important ethical differences. While human actions can be explained as a result of causal mechanisms, as a meaningful choice based on reasons, or as some combination of the two, it is morally important that social scientists respect others by recognizing them as persons. Interpretive explanations directly respect their subjects in this way, while purely causal explanations do not. Yet although causal explanations are not themselves expressions of respect, they (...) can be used in respectful ways if they are incorporated into subjects’ self-directed projects. This can occur when subjects correctly understand and freely adopt researchers’ goals through a process of informed consent. It can also occur when researchers correctly understand and adopt their subject’s goals, using their research to empower those they study. (shrink)

Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores (...) were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries. (shrink)

We humans experience ourselves as objects and as subjects. The distinction initiated by Kant between consciousness of oneself as object and consciousness of oneself as subject was a strict one. The rigidity of that distinction has been challenged by philosophers from the continental and the analytic traditions [1]. From another perspective, researches about animal self-awareness are widening the horizon of studies relative to the nature of self-consciousness [2]. These various perspectives introduce the interest about addressing consciousness of oneself as (...) object and as subject in an evolutionary background. We propose here to follow that path by using an existing scenario about the evolutionary nature of self-consciousness based on evolutions of representations and of inter-subjectivity [3, 4]. The scenario presents an evolutionary approach that can introduce self-consciousness as an acting body and self-consciousness as a thinking and feeling entity. These two aspects of self-consciousness are then compared to consciousness of oneself as object and as subject. The scenario proposes that an evolution of inter-subjectivity brought our pre-human ancestors to reach the capability of identifying with their conspecifics. This process coupled with an evolution of representations led our ancestors to build up representations of themselves as entities existing in the environment, like the conspecifics they identified with were represented. As conspecifics were perceived as existing and acting in the environment, identifying with them led to an elementary version of self-consciousness as an acting body, close to self-consciousness as object. Also, as different conspecifics could display very different behaviors like dominant or submitted, it was not possible to identify with them spontaneously. Knowing and understanding one's own identity as perceived by other members of the group was necessary for a pertinent identification with conspecifics. Such need to think about one's own characteristics and identity introduced self-consciousness as a thinking and feeling entity, close to an elementary version of self-consciousness as subject. In addition, the mental states of the thinking and feeling subject monitoring the actions of the body object address the common evolutionary source for consciousness of oneself as object and as subject. We present here that evolutionary approach to consciousness of oneself as object and as subject with the corresponding phylogenetic outcomes relative to the mind-body problem. Continuations are proposed. (shrink)

Psychiatrist Stuart Grassian has proposed the term “SHU syndrome” to name the cluster of cognitive, perceptual and affective symptoms that commonly arise for inmates held in the Special Housing Units (SHU) of supermax prisons. In this paper, I analyze the harm of solitary confinement from a phenomenological perspective by drawing on Husserl’s account of the essential relation between consciousness, the experience of an alter ego and the sense of a real, Objective world. While Husserl’s prioritization of transcendental subjectivity over transcendental (...) intersubjectivity underestimates the degree to which first-person consciousness is constitutively intertwined with the embodied consciousness of others, Husserl’s phenomenology nevertheless provides a fruitful starting-point for a philosophical engagement with the psychiatric research on solitary confinement. (shrink)