In this paper, I explore the ethics of subject selection in the context of biomedical research. I reject a key principle of what I shall refer to as the standard view. According to this principle, investigators should select participants so as to minimise aggregate risk to participants and maximise aggregate benefits to participants and society. On this view, investigators should exclude prospective participants who are more susceptible to risk than other prospective participants. I argue instead that investigators should (...) select subjects in accordance with an alternative principle: formal equality of opportunity. According to this principle, investigators must treat all prospective participants the same unless differential treatment is warranted by the scientific goals of the study or the need to promote participants' medically related interests. All prospective participants (1) who meet the scientifically defined eligibility criteria and (2) for whom participation is consistent with their medically related interests should have an equal, formal opportunity to participate in the study. Prospective participants should not be excluded simply because they are more susceptible to risk than others. (shrink)

Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing that the principle of fair subject selection is best understood as a bundle of four distinct sub-principles, each with normative force and each yielding distinct imperatives: (1) fair inclusion; (2) fair burden sharing; (3) fair opportunity; (...) and (4) fair distribution of third-party risks. We first map out these distinct sub-principles, and then identify the ways in which they yield conflicting imperatives for the design of inclusion and exclusion criteria, and the recruitment of participants. We then offer guidance for how decision makers should navigate these conflicting imperatives to ensure that participants are selected fairly. (shrink)

This chapter provides a critical overview and interpretation of fair subject selection in clinical and social scientific research. It first provides an analytical framework for thinking about the problem of fair subject selection. It then argues that fair subject selection is best understood as a set of four subprinciples, each with normative force and each with distinct and often conflicting implications for the selection of participants: fair inclusion, fair burden sharing, fair opportunity, and (...) fair distribution of third-party risks. It then defends an approach to navigating the conflicting imperatives of these subprinciples, one which privileges the need to include epistemically distinct groups in research, before concluding by considering the most pressing research questions regarding fair subject selection. (shrink)

Part I: Consciousness and the metaphysics of experience. Orientations. What I believe. The privacy of experience. Final causes. The importance of subjectivity : an inaugural lecture. Is consciousness mysterious? Consciousness. The distinctiveness of American philosophy. The world of description and the world of acquaintance -- Part II: The metaphysics of time and the absolute. The unreality of time. Ideal immortality. Russell and Bradley on relations. The self and its world in Bradley and Husserl. Absolute idealism. Pantheism -- Part III: Ethics, (...) animal rights, and the environment. The greatest happiness principle. Is the esse of intrinsic value percipi? Pleasure, pain and value. Metaphysics, physicalism, and animal rights. Vivisection, morals, medicine : commentary from an antivivisectionist philosopher. Non-human rights : an idealist perspective. Are there intrinsic values in nature? An idealist's prayer for the world. (shrink)

Volume 20, Issue 2, February 2020, Page 33-35.

Ethics and ethical principles extend to all spheres of human activity. They apply to our dealings with each other, with animals and the environment. They should govern our interactions not only in conducting research but also in commerce, employment and politics. Ethics serve to identify good, desirable or acceptable conduct and provide reasons for those conclusions. Fair subject selection is the first and foremost concern which must be ensured before initiating a research project. Which subjects may enroll in (...) the research is determined by the study’s inclusion or exclusion criteria. One of the important aspects of fair subject selection is to have an oversight system through International Review Board (IRB) to review to conduct the research and to have approval whether subject selection is fair or not. (shrink)

This study discusses the results of a survey of 1,800 articles published in American medical journals from 1985--1996. The study finds 9% of these articles reported research that uses only male subjects to examine medical conditions that affect both sexes; the ratio of research on female to male conditions among these articles was greater than 5:1; but 76.5% of the articles reported research that includes both male and female subjects. The study also discusses evidence that sex biases against women (and (...) men) are decreasing. This study also offers some possible psychological, institutional, medical, and economic explanations of the sex biases in medical research published in American journals, and discusses some policy implications of sex biases in medical research. The study concludes by urging others to conduct more empirical research on sex biases in medical research. (shrink)

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject (...) class='Hi'>selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials. (shrink)

Volume 20, Issue 2, February 2020, Page 38-41.

Volume 20, Issue 2, February 2020, Page 25-27.

Timothy Sprigge was one of the leading exponents of philosophical idealism in the last fifty years. The idealist worldview, long unfashionable, has been coming back into favour, and Sprigge's work has found a new readership. These selected essays focus on the view of consciousness on which his unique system of metaphysics and ethics is based.

Volume 20, Issue 2, February 2020, Page 30-32.

Volume 20, Issue 2, February 2020, Page 22-24.

The article by MacKay and Saylor (2020) claims that the principle of fair subject selection yields conflicting imperatives (e.g. in the case of pregnant women) and should be understood as “a bundle of four distinct sub-principles” (i.e. fair inclusion, burden sharing, opportunity, distribution of third-party risks), each having conflicting normative recommendations (MacKay and Saylor 2020). The authors also offer guidance as to how we should navigate between subprinciples that may conflict with each other. The problem is a crucial (...) one since fair subject selection is one of the principles regulating clinical research that produces generalizable knowledge with the potential of improving people’s health. Therefore, there may be cases where the way in which participants are selected directly influences the generalizability (or its lack) of the clinically relevant knowledge and its value (if any) to different groups. In my commentary article, written from the philosophical perspective, I notice a number of interrelated problems which I believe have not been discussed thoroughly in the target article: (1) the precise way in which health care priority setting should influence the content of health research priority setting and fair inclusion principles; (2) the distinction between group and individual benefits and burdens from clinical research; (3) the reference class problem in medical research. (shrink)

In their Target Article, “Promoting Ethical Payment in Human Infection Challenge Studies,” Lynch et al. propose a framework for ethical payment to research participants and apply it to the c...

Given that many clinical research studies struggle to meet their recruitment goals, researchers are eager to identify and employ strategies that will maximize reach to eligible and int...

Volume 20, Issue 2, February 2020, Page 20-22.

Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, (...) the results of an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other sponsored by POG, covering a twenty-year time span are presented. The POG trials had far fewer eligibility criteria than the NSABP studies, suggesting that large numbers of criteria may not be necessary for high quality research. In the third chapter, the impact of subjective eligibility criteria on enrollment and investigator uncertainty is explored. Subjective criteria were associated with more variable enrollment decisions and greater uncertainty. Such criteria represent a threat to the validity, conduct and interpretation of trials and, therefore, should only be included when carefully justified. The fourth chapter examines the accuracy of the reporting of eligibility criteria in sets of corresponding study protocol, methods paper, journal article, and Clinical Alert. Important information is lost at each step in the dissemination of study results. Unnecessary criteria ought to be dropped at a trial's inception; all other criteria must be reported faithfully. The fifth chapter attempts to provide a comprehensive philosophical account of just selection procedures for clinical research using the political philosophy of Michael Walzer. The sixth, and last, chapter, discusses explanatory and pragmatic approaches to clinical trial design, overlapping scientific and ethical concerns related to eligibility criteria, and questions for further study. (shrink)

Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by (...) trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research. (shrink)

This scarce antiquarian book is a facsimile reprint of the original. Due to its age, it may contain imperfections such as marks, notations, marginalia and flawed pages. Because we believe this work is culturally important, we have made it available as part of our commitment for protecting, preserving, and promoting the world's literature in affordable, high quality, modern editions that are true to the original work.

Wittgenstein, in his famous critique of philosophy, noted that the influence of an idea can be such that it alters the way that we see the world. “It is like a pair of glasses on our nose through which we see whatever we look at,” he said. “It never occurs to us to take them off.” This view of the power of an idea suggests that the interpretation of an event, and what response this event calls for, can depend upon (...) the view one has of the world. A person who is naive about medical facts may, for example, interpret chest pain upon exertion as a sign that he is “overdoing it”; were he more medically knowledgeable, the same symptom might be interpreted as a possible indicator of coronary artery disease. The naive interpretation calls for rest; the informed interpretation calls for medical attention as well. (shrink)

The chapter explores whether, or to what extent, recent work in experimental philosophy puts pressure on the idea that the concept of causation is ‘egalitarian’. Causal selection – where experimental subjects tend to rate the causal strength of (for example) a norm-violator more strongly than a non-norm-violator – is a well established phenomenon, and is in prima facie tension with an egalitarian conception of causation; it also, indirectly, puts prima facie pressure on the idea that causation is a worldly (...) phenomenon whose obtaining is independent of facts about norms. The chapter explores both the various psychological mechanisms and the broadly pragmatic approaches to explaining causal selection. It argues that the answer to the question whether or not the concept of causation is egalitarian is currently significantly empirically underdetermined, and suggests some avenues for further investigation. (shrink)

As biomedical research with volunteers was expanded in the United States, the rule of subject selection, constituting scientific and ethical criteria, was generated in 1981 to resolve selection bias in research. Few historical studies, however, have investigated the role of this new hybrid rule in institutional review systems. This paper describes how bioethics commissions and federal agencies have created the subject selection rule based on the concept of justice. I argue that the standardization of this (...) rule as temporal measures, linked with risk-benefit assessment, has reformed the review mechanism, specifically investigators’ modification of research plans, thereby developing justice as balancing. (shrink)

Controlled human infection (CHI) studies involve the deliberate exposure of healthy research participants to infectious agents to study early disease processes and evaluate interventions under controlled conditions with high efficiency. Although CHI studies expose participants to the risk of infection, they are designed to offer investigators unique advantages for studying the pathogenesis of infectious diseases and testing potential vaccines or treatments in humans. One of the central challenges facing investigators involves the fair selection of research subjects to participate in (...) CHI studies. While there is widespread agreement that investigators have a duty to select research participants fairly, this principle also yields conflicting ethical imperatives, for example requiring investigators to both exclude potential participants with co‐morbidities since they face increased risks, but also to include them in order to ensure generalizability. In this paper we defend an account of fair subject selection that is tailored to the context of CHI studies. We identify the considerations of fairness that bear directly on selecting participants for CHI studies and provide investigators and members of IRBs and RECs with a principled way to navigate the conflicting imperatives to which these considerations give rise. (shrink)

Natural selection is commonly seen not just as an explanation for adaptive evolution, but as the inevitable consequence of “heritable variation in fitness among individuals”. Although it remains embedded in biological concepts, such a formalisation makes it tempting to explore whether this precondition may be met not only in life as we know it, but also in other physical systems. This would imply that these systems are subject to natural selection and may perhaps be investigated in a (...) biological framework, where properties are typically examined in light of their putative functions. Here we relate the major questions that were debated during a three-day workshop devoted to discussing whether natural selection may take place in non-living physical systems. We start this report with a brief overview of research fields dealing with “life-like” or “proto-biotic” systems, where mimicking evolution by natural selection in test tubes stands as a major objective. We contend the challenge may be as much conceptual as technical. Taking the problem from a physical angle, we then discuss the framework of dissipative structures. Although life is viewed in this context as a particular case within a larger ensemble of physical phenomena, this approach does not provide general principles from which natural selection can be derived. Turning back to evolutionary biology, we ask to what extent the most general formulations of the necessary conditions or signatures of natural selection may be applicable beyond biology. In our view, such a cross-disciplinary jump is impeded by reliance on individuality as a central yet implicit and loosely defined concept. Overall, these discussions thus lead us to conjecture that understanding, in physico-chemical terms, how individuality emerges and how it can be recognised, will be essential in the search for instances of evolution by natural selection outside of living systems. (shrink)

This is the long-awaited third volume of philosophical writings by Davidson, whose influence on philosophy since the 1960s has been deep and broad. His first two collections, published by Oxford in the early 1980s, are recognized as contemporary classics. His ideas have continued to flow; now, in this new work, he presents a selection of his best work on knowledge, mind, and language from the last two decades. It is a rich and rewarding feast for anyone interested in philosophy, (...) and essential reading for anyone working on these topics. (shrink)