This new edition of Charles Fried's 'Medical Experimentation' includes a general introduction by Franklin Miller and the late Alan Wertheimer, a reprint of the 1974 text, an in-depth analysis by Harvard Law School scholars I. Glenn Cohen and D. James Greiner, and a new essay by Fried reflecting on the original text and how it applies to the contemporary landscape of medicine and medical experimentation.

Neuroscience is a laboratory-based science that spans multiple levels of analysis from molecular genetics to behavior. At every level of analysis experiments are designed in order to answer empirical questions about phenomena of interest. Understanding the nature and structure of experimentation in neuroscience is fundamental for assessing the quality of the evidence produced by such experiments and the kinds of claims that are warranted by the data. This article provides a general conceptual framework for thinking about evidence and experimentation in (...) neuroscience with a particular focus on two research areas: cognitive neuroscience and cognitive neurobiology. (shrink)

Spectacular treatment disasters in recent years have made it clear that informal "let's-try-it-and-see" methods of testing new proposals are more risky now than ever before, and have led many to call for a halt to experimentation in clinical medicine. In this easy-tp-read, philosophical guide to human experimentation, William Silverman pleads for wider use of randomized clinical trials, citing many examples that show how careful trials can overturn preconceived or ill-conceived notions of a therapy's effectiveness and lead to a clearer understanding (...) of clinical anomalies. Because it gives careful guidance on setting up trials and avoiding conceptual pitfalls, this book will be of great interest to all epidemiologists and clinical statisticians, and to a wide varitey of clinicians, pharmacologists, and nurses. Since it requires no medical or statistical knowledge, it will also appeal to ethicists, lawyers, and the general public. (shrink)

Millions of animals are used every year in oftentimes extremely painful and distressing scientific procedures. Legislation of animal experimentation in modern societies is based on the supposition that this is ethically acceptable when certain more or less defined formal (e.g. logistical, technical) demands and ethical principles are met. The main parameters in this context correspond to the “3Rs” concept as defined by Russel and Burch in 1959, i.e. that all efforts to replace, reduce and refine experiments must be undertaken. The (...) licensing of animal experiments normally requires an ethical evaluation process, oftentimes undertaken by ethics committees. The serious problems in putting this idea into practice include inter alia unclear conditions and standards for ethical decisions, insufficient management of experiments undertaken for specific (e.g. regulatory) purposes, and conflicts of interest of ethics committees’ members. (shrink)

Animal rights activists are often accused of caring more about animals than about human beings. How, it is asked, can activists condemn the use of animals in biomedical research—research that improves human health and saves human lives? In this article, I argue that even if animal experimentation might eventually provide cures for many serious diseases, given the present state of the world, we are not justified supporting this research; rather, we ought to devote our limited resources to other forms of (...) humanitarian assistance. (shrink)

Industry is a major source of funding for scientific research. There is also a growing concern for how it corrupts researchers faced with conflicts of interest. As such, the debate has focused on whether researchers have maintained their integrity. In this article we draw on both the history of medicine and formal modeling to argue that given methodological diversity and a merit-based system, industry funding can bias a community without corrupting any particular individual. We close by considering a policy solution (...) that may seem to promote unbiased inquiry but that actually exacerbates the problem without additional restrictions. (shrink)

This article presents the experimentation of a device for trainees focusing on strengths, in the context of initial university training. Based on a theoretical corpus and self-analysis of the practices of a supervisor, this device was implemented with a dozen trainees. The concepts of psychopedagogy of well-being, positive professional identity, as well as the postures of supervisors will explore how a force-based approach to coaching trainees can help them develop their professional skills. but also to a positive identity development in (...) order to face the multiple challenges of the profession. (shrink)

Avicenna, beside his theoretical discussions about experimentation, practically applied his experimental method to natural sciences studies such as medicine, biology, and meteorology. His theoretical discussions subsume propositions concerning the conditions under which experimental knowledge is attained, the components of this knowledge and its functions. Some of these propositions are as follows: necessity of recurrent observations for acquiring experimental knowledge, certainty plus conditional universality of such knowledge, and its role as demonstrative premises. Investigating the application of his theory in natural sciences (...) propound two new features which were not elaborated in the theoretical discussions: fallibility of experimental knowledge and necessity of systematic observation. This research, using the analytic method and referring to both philosophical and scientific works of Avicenna, clarifies that a comprehensive definition of experimentation is dependent on considering extracted points from practical application of experimental knowledge, beside its theoretical components. (shrink)

New developments in reproductive technology have made headlines since the birth of the world's first in vitro fertilization baby in 1978. But is embryo experimentation ethically acceptable? What is the moral status of the early human embryo? And how should a democratic society deal with so controversial an issue, where conflicting views are based on differing religious and philosophical positions? These controversial questions are the subject of this book, which, as a current compendium of ideas and arguments on the subject, (...) makes an original contribution of major importance to this debate. (shrink)

This chapter contains sections titled: Introduction History of Experimentation on Human Beings Regulation of Human Experimentation Guidelines, Regulations and Directives to Regulate Human Experimentation Regulation of Experimentation in Surgery and Clinical Medicine Discussion References.

This chapter contains section titled: The Diversity of Experimental Practices in Biology Model Organisms Experimental Systems and the “New Experimentalism” in Biology The Nature of Evidence Objectivity and Realism Acknowledgment References Further Reading.

Evolutionary economics often focuses on the comparison between economic competition and the process of natural selection to select the fitter members of a given population. But that neglects the other "half" of an evolutionary process, the mechanism for the generation of new possibilities that is key to dynamic efficiency. My topic is the process of parallel experimentation which I take to be a process of multiple experiments running concurrently with some form of common goal, with some semi-isolation between the experiments, (...) with benchmarking comparisons made between the experiments, and with the "migration" of discoveries between experiments wherever possible to ratchet up the performance of the group. The thesis is that parallel experimentation is a fundamental dynamic efficiency scheme to enhance and accelerate variation, innovation, and learning in contexts of genuine uncertainty or known ignorance. Within evolutionary biology, this type of parallel experimentation scheme was developed in Sewall Wright's shifting balance theory of evolution. It addressed the rather neglected topic of how a population on a low fitness peak might eventually be able to go "downhill" against selective pressures, traverse a valley of low fitness, and then ascend a higher fitness peak. The theme of parallel experimentation is used to recast and pull together dynamic and pluralistic theories in economics, political theory, philosophy of science, and social learning. (shrink)

In this paper I explore a new approach to the ethics of animal experimentation by conceiving of it as a form of rescue. The notion of rescue, I suggest, involves some moral agent performing an action or series of actions, whose end is to prevent or alleviate serious harm to another party, harm that otherwise would have occurred or would have continued to occur, had that moral agent not intervened. Animal experiments that are utilized as a means to alleviate human (...) illnesses mirror the structure of rescue cases and this means that we can and should apply principles of rescue to illuminate the moral status of animal experimentation. To do this I consider various principles of rescue that might justify animal experimentation. I’ll argue that all of these rescue principles are either not independently plausible, or else they fail to imply that animal experimentation is morally justified. This suggests that it is quite difficult to morally justify animal experimentation when conceived as a form of rescue. (shrink)

In this article, I argue that it is wrong to conduct any experiment on a nonhuman which we would regard as immoral were it to be conducted on a human, because such experimentation violates the basic moral rights of sentient beings. After distinguishing the rights approach from the utilitarian approach, I delineate basic concepts. I then raise the classic “argument from marginal cases” against those who support experimentation on nonhumans but not on humans. After next replying to six important objections (...) against that argument, I contend that moral agents are logically required to accord basic moral rights to every sentient being. I conclude by providing criteria for distinguishing ethical from unethical experimentation. (shrink)

_Animal Experimentation: Working Towards a Paradigm Change_ critically appraises current animal use in science and discusses ways in which we can contribute to a paradigm change towards human-biology based approaches.

L’expérimentation animale consiste à tester chez l›animal des questions que l›on se pose chez l’Homme. En recherches appliquées, ces expérimentations nous fournissent des données essentielles dans la lutte contre les maladies humaines ainsi qu’en médecine vétérinaire. Em recherches fondamentales, ces expérimentations qui permettent de mieux connaitre l’Homme et l’Animal nous montrent que le fossé que certains voient entre l’espèce humaine et les animaux n’a probablement pas l’importance qu’on lui donne. Ces recherches nous montrent que certains animaux ont quelquefois des capacités (...) cognitives telles qu’ils n’ont rien à envier aux hommes et que ces animaux sont des êtres sensibles capables de souffrir. Toutes ces recherches nous informent sur notre nature, nos relations avec l’animal et notre place dans le monde animal. Ce constat sur la nature et la proximité de l’Homme et de l’Animal a mené à la création des comités d’éthique. Nous avons besoin de ces animaux mais ils méritent notre respect et les expérimentations nécessaires doivent être faites en obéissant à une certaine éthique. Ces comités s’assurent que les expérimentations animales respectent les règles éthiques dont la plus connue est celle des « 3 R » (Remplacement, Réduction et Raffinement). (shrink)

In the present paper, I go beyond these examples by bringing into play an example that I nd more experimental in nature, namely that of the use of the so-called PSLQ algorithm in researching integer relations between numerical constants. It is the purpose of this paper to combine a historical presentation with a preliminary exploration of some philosophical aspects of the notion of experiment in experimental mathematics. This dual goal will be sought by analysing these aspects as they are presented (...) by some of the protagonists of the eld and discussing them using notions from contemporary philosophy of science. (shrink)

Summary Analogue models are actual physical setups used to model something else. They are especially useful when what we wish to investigate is difficult to observe or experiment upon due to size or distance in space or time: for example, if the thing we wish to investigate is too large, too far away, takes place on a time scale that is too long, does not yet exist or has ceased to exist. The range and variety of analogue models is too (...) extensive to attempt a survey. In this article, I describe and discuss several different analogue model experiments, the results of those model experiments, and the basis for constructing them and interpreting their results. Examples of analogue models for surface waves in lakes, for earthquakes and volcanoes in geophysics, and for black holes in general relativity, are described, with a focus on examining the bases for claims that these analogues are appropriate analogues of what they are used to investigate. A table showing three different kinds of bases for reasoning using analogue models is provided. Finally, it is shown how the examples in this article counter three common misconceptions about the use of analogue models in physics. (shrink)

Many researchers experiment with participatory settings to increase public engagement in research and innovation (R&I). Because of their temporary nature, it often remains unclear how such participatory experiments can contribute to structural change. This paper empirically explores options for bridging this gap. It analyzes how participants can be supported to act as institutional entrepreneurs to actively promote public engagement in R&I. To draw lessons, we analyze empirical material gathered on nineteen Social Labs which were set up to promote the uptake (...) of Responsible Research and Innovation in a European R&I funding program (Horizon 2020). Involvement of motivated participants, insight in their institutional context, and specific methods and management choices that enhance a sense of agency are identified as essential for organizing change. These findings and the resulting framework of interventions may prove valuable for further (action) research into the institutionalization of public engagement in R&I. (shrink)

This chapter contains sections titled: Scandalous Research in the Twentieth Century Basic Principles of Research Ethics Respect for Persons Beneficence Justice Conclusion.

Recent work by Keyser in applied epistemology of experiment has focused on the iterative ‘production’ of knowledge: knowledge stabilizes within a given physical context and it is iteratively tested within that context to meet standards of reliability. This implies that in a given physical context (e.g., laboratory), the inferences, methods/techniques, and physical products form coherence relations with one another. We apply this epistemological stabilization account to the martial arts in order to argue that the context of stabilization dictates the training (...) methods, techniques, and even the philosophical concepts of a given martial arts system. We describe key elements of stabilization pertaining to rules, training methodology, warrior philosophy, and spectator/media tropes. The account of stabilization requires a case study that shows how a dynamic system is stabilized. We describe the stabilization of modern mixed martial arts by tracking it on a time scale, but also in different contexts (e.g., Pancrase, Pride, UFC). (shrink)

Self-experimentation is a valuable companion to self-management in the benefit of pharmaco-cognitive-behavior combination therapies. However, data on individuals participating as active therapeutic agents are sparse. Smoking cessation therapy is an example. Roberts' self-experimentation suggests trying more diversity in research to generate new ideas. This may inform current approaches to the cessation of smoking.

The existential, experiential, ethical, pathic and pre-pathic dimensions of education are essential for the creative composition of subjectivities in institutional spaces, yet educational research and policy tend increasingly to privilege technical discourses and prescriptive approaches both when evaluating ‘what is effective in education’ and when determining educational policy. This essay explores those aspects of the educational experience and educational institutions that are often felt and sensed pre-cognitively by students, parents and teachers, but are seldom given further elaboration or articulation in (...) educational research. We will reflect on what is meant by the experience of education and experience in education, including the struggles to make sense of or understand something, the surprises that strike pre-reflectively, and the ways in which such moments are noticed, pursued, and explored rather than reflexively ‘evaluated’. We then explore the idea of experimentation in institutions, in particular in relation to the range of concepts that Jean Oury introduces in order to move our attention and awareness to questions of experience, existence, atmosphere, and the pathic—the way in which we undergo, sense and participate in the world prior to cognition and the desire for mastery and control of our encounters. Finally, we address the question of the ethics of institutions. (shrink)

Disruptive societal changes following from emerging science and technology have recently led to a growing interest in developing ethical frameworks. Responsible Research and Innovation (RRI) is such a framework that aims to improve the relationship between science and society. Now a decade after its conceptualization, it still seems to suffer from conceptual unclarity and lack of implementation. Since responsibility in research and innovation practice remains as important as ever, we propose to revive the normative potential of RRI by approaching it (...) as a matter of collective democratic experimentation. To further develop this approach, we propose a pragmatist conceptualization inspired by John Dewey, his work on democracy as an ethical way of life and his attention to the contextual nature of responsibility. Furthermore, we show how his interest in social inquiring publics provides a particularly apt foothold from which to operationalize collective democratic experimentation with RRI. We will illustrate the utility of this approach, with specific attention to the social, experimental and public character of social inquiry, by connecting it to the recent call to use social labs methodology to experiment with RRI. From this we draw lessons for future collective democratic experimentation with responsibility in research and innovation practice. (shrink)

ABSTRACT In this paper we argue that the standard focus on problems of informed consent in debates about the ethics of human experimentation is inadequate because it fails to capture a more fundamental way in which such experiments may be wrong. Taking clinical trials as our case in point, we suggest that it is the moral offence of using people as mere means which better characterizes what is wrong with violations of personal autonomy in certain kinds of clinical trials. This (...) account also helps bring out another important way in which the autonomy of the participants in clinical trials my be violated, even in cases where they have given informed consent to their involvement. Where relevant information about the trial is framed in such a way as to induce a patient's participation by appeal to their nonrational preferences, this is also a violation of their autonomy, and one which is distinct from a failure of informed consent. The underlying wrongness of both kinds of violations, we argue, is plausibly captured by the moral offence of using people as mere means. (shrink)

Self-surveillance and self-experimentation are of concern to everyone interested in finding out the factors that increase one's risk of stroke from.

Little is known about how to generate plausible new scientific ideas. So it is noteworthy that 12 years of self-experimentation led to the discovery of several surprising cause-effect relationships and suggested a new theory of weight control, an unusually high rate of new ideas. The cause-effect relationships were: (1) Seeing faces in the morning on television decreased mood in the evening (>10 hrs later) and improved mood the next day (>24 hrs later), yet had no detectable effect before that (0–10 (...) hrs later). The effect was strongest if the faces were life-sized and at a conversational distance. Travel across time zones reduced the effect for a few weeks. (2) Standing 8 hours per day reduced early awakening and made sleep more restorative, even though more standing was associated with less sleep. (3) Morning light (1 hr/day) reduced early awakening and made sleep more restorative. (4) Breakfast increased early awakening. (5) Standing and morning light together eliminated colds (upper respiratory tract infections) for more than 5 years. (6) Drinking lots of water, eating low-glycemic-index foods, and eating sushi each caused a modest weight loss. (7) Drinking unflavored fructose water caused a large weight loss that has lasted more than 1 year. While losing weight, hunger was much less than usual. Unflavored sucrose water had a similar effect. The new theory of weight control, which helped discover this effect, assumes that flavors associated with calories raise the body-fat set point: The stronger the association, the greater the increase. Between meals the set point declines. Self-experimentation lasting months or years seems to be a good way to generate plausible new ideas. Key Words: breakfast; circadian; colds; depression; discovery; fructose; innovation; insomnia; light; obesity; sitting; standing; sugar. (shrink)

The article discusses the issue of the justification of experimenting on human subjects from the point of view of the individual participant. The discussion is conducted on three levels, which can be viewed as a hierarchy:I. Rationality: does one have good self-regarding reasons to subject oneself to medical experimentation?II. Justice: does one have a duty or an obligation to take part in medical research?III. Virtue: ought one contribute to the long-term attempt to promote medical knowledge and the overall health of (...) human beings?Rationality is shown to have only a limited force in such a justification, since many experiments cannot be shown to serve the interests of the participant in any way. Justice fares slightly better, since it is based on the idea of a social contract which goes beyond individual prudence. But, since many medical experiments promote the health only of future generations, the condition of mutuality, which is one of the bases of a social contract, is not satisfied. Thus, the ultimate reason to take part in medical research is associated with the supererogatory volunteering of people, who are motivated by the wish to contribute to a highly valuable enterprise with no expectation of return.The three types of reasons are complementary rather than exclusive, and the potential failure of all of them may lead to the undesirable commercialization of the field. Der Beitrag untersucht die Frage, ob und wie medizinische Versuche an Menschen aus der Sicht des einzelnen Teilnehmers gerechtfertigt werden können. Die Diskussion dieser Frage wird auf drei Ebenen geführt, die sich in einem Stufenverhältnis darstellen lassen,I. der Ebene der Zweckrationalität: Gibt es gute Gründe, und zwar durchaus des individuellen Eigennutzes, sich selbst für medizinische Versuche zur Verfügung zu stellen?II. der Ebene der Gerechtigkeit: Besteht eine Pflicht oder eine Verbindlichkeit zur Teilnahme an medizinischer Forschung?III. der Ebene der Tugend: Soll man zu dem auf lange Sicht angelegten Versuch beitragen, das medizinische Wissen und die Gesundheit der Menschen insgesamt zu fördern?Es wird gezeigt, daß das Argument der Zweckrationalität für eine mögliche Rechtfertigung nur von begrenzter Bedeutung ist. Denn viele Experimente dienen den Interessen des unmittelbaren Teilnehmers nachweislich in keiner Weise. Das Argument der Gerechtigkeit hat zwar eine etwas größere Kraft, weil Gerechtigkeit auf der Idee eines Gesellschaftsvertrags beruht, die über den Horizont individueller Klugheit hinausreicht. Da aber viele medizinische Experimente nur die Gesundheit zukünftiger Generationen fördern, ist die Bedingung der Gegenseitigkeit, die eine der Grundlagen des Gesellschaftsvertrags bildet, nicht erfüllt. Der dritte und letzte Grund für eine Teilnahme an medizinischer Forschung steht deshalb in enger Verbindung mit dem freiwilligen supererogatorischen Verhalten von Leuten, die durch den Wunsch motiviert sind, ohne Aussicht auf Gegenleistung zu einer höchst wertvollen Unternehmung etwas beizutragen.Die drei Arten von Gründen ergänzen sich mehr, als daß sie sich ausschließen. Ein mögliches Scheitern aller dieser Gründe könnte zu einer unerwünschten Kommerzialisierung der Teilnahme an medizinischen Experimenten führen. (shrink)

This essay focuses on three primary issues i. The conceptual resources offered by Spinoza to challenge the idealism and perfectionism underpinning much educational theory and dominant educational imaginaries; ii. His descriptions of a non-ideal, practical and systematic approach to developing understanding that could be applied to educational theorising and practice; and iii. The potential for a different vision of education premised upon understanding the human as simply a part of nature. Decentring the human and treating affective and mental life as (...) one would lines, planes, and bodies, as Spinoza claims we must in Ethics, invites another way of thinking about the politics and ethics of educational practice. Enacting experimental approaches to pedagogy produces new subjectivities and also invents new connections and relations between different bodies and different ideas. I argue that a properly Spinozist understanding of education would require it to be understood through practices of experimentation, in short, developing capabilities to compose relations in such a way that one also develops a the awareness of oneself as finite, dependent, vulnerable and as a part of nature. Seemingly paradoxically then, having understood how and that one is determined, and which bodies agree or disagree with one, one becomes more capable of agency and thus an ethical life. (shrink)

This essay explores some moral problems raised by experimentation involving the human fetus. In the first part of the essay three examples of fetal experimentation from the medical literature are described in some detail. Next, the ethical and legal arguments employed in the two major existing public policy-documents on fetal experimentation are analyzed. Finally, the author seeks to identify four fundamental presuppositions which underlie divergent normative positions on the problem of fetal experimentation.

It is shown that the Maxwell-Lorentz equations can be deduced from the law of Biot-Savart by simply performing some theoretical experimentations.

Human experimentation can have different meanings: indeed, with the development of medical research, therapeutic acts have to be distinguished from acts of cognitive values. For each kind of acts, specific conditions of acceptability and specific protections of human beings have to be defined.Human experimentation must be envisaged at different levels to evaluate ethical aspects: its scientific value, the risks, benefits envisaged, the populations implicated, etc…The individual consent must be present too in the relationship between the subject and the doctors. In (...) fact, is a real consent possible?Instead to insist on problems in terms of medical research, one would have to insist perhaps more on the fact that the medical practice in general would have to answer more to ethical grounds and to scientific rules. It is the non scientific medicine which is immoral and dangerous, as well the medicine with financial interests, or also the medecine without experimentation.The main arguments must remain at the level of the dignity of the persons, autonomy and freedom of choice must remain the fundamental values. (shrink)

Recent scientific advances have indicated that it may be technically feasible to sustain human embryos in vitro beyond 14 days. Research beyond this stage is currently restricted by a guideline known as the 14-day rule. Since the advances in embryo culturing there have been calls to extend the current limit. Much of the current debate concerning an extension has regarded the 14-day rule as a political compromise and has, therefore, focused on policy concerns rather than assessing the philosophical foundations of (...) the limit. While there are relevant political considerations, I maintain that the success of extension arguments will ultimately depend on the strength of the justifications supporting the current 14-day limit. I argue that the strongest and most prevalent justifications for the 14-day rule—an appeal to individuation and neural development—do not provide adequate support for the limit of 14 days. I instead suggest that an alternative justification based on sentience would constitute a more defensible basis for embryo protection and that a consideration of such grounds appears to support an amendment to the current limit, rather than the retention of it. While these conclusions do not establish conclusively that the current limit should be extended; they do suggest that an extension may be warranted and permissible. As such, this paper offers grounds on which a reassessment of the 14-day rule may be justified. (shrink)

There has been relatively little effort to provide a systematic overview of different forms of exploratory experimentation (EE). The present paper examines the growing subdiscipline of nanotoxicology and suggests that it illustrates at least four ways that researchers can engage in EE: searching for regularities; developing new techniques, simulation models, and instrumentation; collecting and analyzing large swaths of data using new experimental strategies (e.g., computer-based simulation and "high-throughput" instrumentation); and structuring an entire disciplinary field around exploratory research agendas. In order (...) to distinguish these and other activities more effectively, the paper proposes a taxonomy that includes three dimensions along which types of EE vary: (1) the aim of the experimental activity, (2) the role of theory in the activity, and (3) the methods or strategies employed for varying experimental parameters. (shrink)