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.

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)

Modern medicine is built on a long history of medical experimentation. Experiments in the past often exploited more vulnerable patients. Questionable ethics litter the history of medicine. Without such experiments, however, millions of lives would be forfeited. This paper asks whether all the ``unethical'' experiments of the past were unjustifiable, and do we still exploit the poorer members of the community today? It concludes by wondering if Harris is right in his advocacy of a moral duty to participate (...) in medical research. (shrink)

Relatively subtle forms of exploitation of human subjects may arise from the inefficiency or incompetence of a researcher, from the existence of a power imbalance between principal and subject, or from the uneven distribution of research risks among various segments of the population. A powerful and knowledgeable person (or institution) may perpetrate the exploitation of an unempowered and ignorant individual even without intending to. There is an ethical burden on the former to protect the interests of the vulnerable. Excessive or (...) insufficient compensation may be exploitative. However, genuine economic imperatives motivating needy volunteers have to be considered. These forms of exploitation should be appreciated in the context of social and cultural factors suggesting that the relationship between researcher and subject cannot properly be appraised as a contractual undertaking. While compliance with pertinent codes and regulations minimises the exploitative potential, they cannot be enforced in a way that does not recognise a society's peculiar characteristics. The experience with some Filipino cultural traits illustrates this point. (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)

Medical research with children has been the subject of ongoing debate. The reason for controversy is clear. As with research on adults, one must strike a balance between two goals – promoting the health of children through advances in scientific knowledge and protecting child research subjects from exploitation and harm. However, because of their age and relative immaturity, children cannot protect their own interests as well as adult subjects can. Yet as they progress toward adulthood, increasing care must be (...) taken to involve children in decisions that affect them, even to the extent of allowing them to make choices that may have serious and long-term consequences. (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.

The author argues the following hypothesis: the medical clinic is an experimental practice, in the sense given to this term by Claude Bernard, and the clinic is its specific laboratory. Its object is not the disease, but the patient. Careful examination of the clinic attests to its very close proximity to the experimental method, and the comparison also raises a number of difficulties. The main obstacle arises from the specificity of medicine, which involves treating individual human subjects whose words (...) cannot be suppressed. Its main challenge is to combine a linguistic practice with an experimental method. (shrink)

_The dynamic development of medical technologies, i.e. the use of medicinal products and medical procedures, requires reflection on the ways to ensure the safety of patients and people using such methods of treatment (medical professionals) in legal and ethical terms. This applies in particular to the currently observed influence of the media on the actions taken in the health care system in Poland as well as individual decisions of patients on the use of the offered drugs and (...) other medical procedures._ _The article presents selected legal provisions defining the conditions for the use of medicinal products (drugs) and experimental medical procedures. The basic element of the considerations is to indicate the legal conditions for this type of use of medical technologies understood in this way, also in a broader context – with the characteristics of ethical conditions for „the media message”, including ensuring its proper quality for the protection of public health._. (shrink)

In order to maximize human performance, defence forces continue to explore, develop, and apply human performance enhancement (HPE) methods, ranging from pharmaceuticals to (bio)technological enhancement. This raises ethical, legal, and societal concerns and requires organizing a careful reflection and deliberation process, with relevant stakeholders. We discuss a range of ethical, legal, and societal aspects (ELSA), which people involved in the development and deployment of HPE can use for such reflection and deliberation. A realistic military scenario with proposed HPE application can (...) serve as a starting point for such an iterative and participatory process. Stakeholders can discuss this application, modify its features, and design appropriate processes around it – for instance, procedures for informed consent. We propose that organizing aspects into these three categories – ethical, legal, and societal – can help involve appropriate interlocutors at different moments: legal aspects with people in strategy or management roles, from the start of a project; ethical aspects with people in operations and medical roles, during development; and societal aspects with people in communication and personnel roles, during deployment. Notably, we developed and discussed this framework and the three aspects in close collaboration with personnel from the military. (shrink)

Debates about the genuine disease status of controversial diseases rely on intuitions about a range of factors. Adopting tools from experimental philosophy, this paper explores some of the factors that influence judgments about whether low sexual desire should be considered a disease and whether it should be medically treated. Drawing in part on some assumptions underpinning a divide in the literature between viewing low sexual desire as a genuine disease and seeing it as improperly medicalized, we investigate whether health and (...) disease judgments are affected by factors such as an individual’s gender, the cause of the low desire, whether the desire is high or low, and both personal and societal valuations of the condition. Our main findings indicate that (a) the cause of a condition influences whether it is judged a disorder, (b) how the individual values the condition influences whether the condition is seen as a proper target of medical intervention, and (c) perceived dysfunction influences judgments regarding health, disorder classification, medicalization, and medical intervention. Our findings help further illuminate the intricate interplay of factors that influence judgments about health and disease in controversial conditions. (shrink)

The following text is a voice in the discussion around normative problems of innovative therapies. It particularly refers to problems related to the contribution of experimental therapies to the development of medical knowledge, also discussed in this issue in the article by Olga Dryla "Expanded access programs as a source of cognitive data.".

Background: The experimental method to acquire knowledge about efficacy and efficiency of medical procedures is well established in evidence-based medicine. A method to attain evidence about the significance of diseases and interventions from the patients' perspectives taking into account their right to self-determination about their lives and bodies has however not been sufficiently characterized.Design: Identification of a method to acquire evidence about the clinical significance of disease and therapeutic options from the patients' perspectives.Arguments: Communication between patient and physician is (...) analyzed as the method to attain evidence about what is at stake for individual patients in disease and therapy. It is the method that enables physicians to directly take into account patients' disease experiences and their aims regarding treatments. These patients' perspectives in turn determine the clinical significance of diagnoses and therapeutic options, if patient-autonomy is taken seriously.Conclusions: A full account of evidence-based medicine needs to include experimentation and communication between physician and patient as equally important methods to attain evidence necessary to practice patient-oriented medicine. The communicative method is especially important for primary physicians as they direct patients within the medical system to have their medical problems most effectively and efficiently addressed. (shrink)

Objective Analyze racial differences in comfort with medical research using an alternative to the traditional approach that treats white people as a raceless norm.Methods Quantitative analysis of survey responses (n = 1,570) from Black and white residents of the US to identify relationships between perceptions of research as a right or a risk, and comfort participating in medical research.Results A lower proportion of white respondents reported that medical experimentation occurred without patient consent (p < 0.001) and (...) a higher proportion of white respondents reported that it should be their right to participate in medical research (p = 0.02). Belief in one’s right to participate was significantly predictive of comfort (b = 0.37, p < 0.001). Belief in experimentation without consent was significantly predictive of comfort for white respondents but not for Black respondents in multivariable analysis.Conclusions A rights-based orientation and less concern about the risks of medical research among white respondents demonstrate comparative advantage. Efforts to diversify medical research may perpetuate structural racism if they do not (1) critically engage with whiteness and its role in comfort with participation, and (2) identify and respond specifically to the needs of Black patients. (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)

Definition of the problem: A `experimental treatment' is defined as the use of a not yet approved medical treatment or product in a single patient outside the scope of regular clinical trials. Especially in oncology the patient is usually in a desperate situation and does not respond to other treatments. Even if he or she is fully informed about the risks he or she may occasionally make an irrational decision.Discussion of the problem: The moral problems in experimental treatments have (...) to do with the medical and scientific quality of the treatment and the patient-physician relationship. It is argued that there are also moral duties for pharmaceutical manufacturers and health insurrance companies.Conclusion: A regulation of experimental treatment trials is necessary both for physicians and for pharmaceutical manufacturers. (shrink)

The Experiment Must Continue is a beautifully articulated ethnographic history of medical experimentation in East Africa from 1940 through 2014. In it, Melissa Graboyes combines her training in public health and in history to treat her subject with the dual sensitivities of a medical ethicist and a fine historian. She breathes life into the fascinating histories of research on human subjects, elucidating the hopes of the interventionists and the experiences of the putative beneficiaries. Historical case studies highlight (...) failed attempts to eliminate tropical diseases, while modern examples delve into ongoing malaria and HIV/AIDS research. Collectively, these show how East Africans have perceived research differently than researchers do and that the active participation of subjects led to the creation of a hybrid ethical form. By writing an ethnography of the past and a history of the present, Graboyes casts medical experimentation in a new light, and makes the resounding case that we must readjust our dominant ideas of consent, participation, and exploitation. With global implications, this lively book is as relevant for scholars as it is for anyone invested in the place of medicine in society. (shrink)

This book takes a novel approach by highlighting comparative and long-term historical perspectives on experimental practice. The juxtaposition of accounts of natural, social, and medical experimentation is very enlightening, especially because the authors put the emphasis on the different kinds of objects of experimentation (physical matter, chemical reagents, social groups, organizations, sick individuals, archeological remains) and demonstrate how much the kinds of objects matter for the practice of experimentation, its methods, tools, and methodologies. Taken together, the (...) chapters raise several fascinating questions for further study: What do these different approaches have in common? Why do we call them “experimentation”? What are the intersections among the fields and their developments? The volume engages philosophical approaches that are not well known to Anglophone readers (Bachelard, Bergson, Bernard, Canguilhem, among others) and brings to attention a wealth of Francophone secondary literature on past and present scientific experimentation. The collection fills a yawning gap in science, science studies, and philosophy of science teaching, making it particularly valuable philosophers and historians of science in all subfields. (shrink)

The subject of this article are the definitional and regulatory aspects of experimental (or innovative) therapies, understood either as new and unproven treatment methods that can be tested – and for this purpose used – also in clinical trials, or as applications of these new and unproven procedures in medical practice. After a short introduction, recalling one of the important sources of the concept of experimental or innovative therapy, which was the Belmont Report, I first discuss the problems related (...) to the definition of experimental therapy (as a new and nonvalidated medical procedure used to improve the patient's health), and then the controversial issues related to its regulation (including in particular the required control to which each such therapeutic intervention should be subject). Finally, I point out the importance of the discussions on experimental therapy reported in this article, conducted in other countries or in international contacts, for the necessary revision or reinterpretation of Polish regulations regarding therapeutic experiments. (shrink)

Climate change, nutrition, poverty and medical drugs are widely discussed and pressing issues in science, policy and society. Despite these issues being of great importance for the quality of our lives it remains unclear how well people understand them. Specifically, do particular demographic and socioeconomic factors explain variation in public understanding of these four concepts? To what extent are people’s changes in understanding associated with changes in their behaviour? Do people judge scientific practices relying on the more descriptive concepts (...) of climate change and effective medical drugs to be more objective (less controversial) than practices relying on the more value-laden concepts of poverty and healthy nutrition? To address these questions, an experimental survey and regression analyses are conducted using data collected from about one thousand participants across different continents. The study finds that public understanding of science is generally low. A smaller proportion of people were able to correctly identify the common explanation accepted internationally among the scientific community for climate change and effectiveness of medical drugs (42% and 43% of participants in the study, respectively) than for poverty and healthy nutrition (61% and 65% of participants, respectively). Older age and political non-conservativeness were the strongest predictors of correctly understanding these four concepts. Greater levels of education and political non-conservativeness were in turn the strongest predictors of people’s reported changes in their behaviour based on their improved understanding of these concepts. Because climate change is among the least understood scientific concepts but is arguably the greatest challenge of our time, better efforts are needed to improve how media, awareness campaigns and education systems mediate information on the topic in order to tackle the large knowledge deficits that constrain behavioural change. (shrink)

Specialising in Jewish Medical Ethics – a term, I believe, first used as the title of my doctor's thesis (1955) subsequently condensed and revised in book form (1959) – I frequently receive inquiries from individuals and organisations seeking guidance on the Jewish attitude to moral issues in medicine. After a review of my voluminous correspondence on many phases of this subject, I have made a small selection on a variety of topics. The correspondence on the last of the four (...) topics, ‘medical experimentation on Animals’, is the longest, because it contains an element of polemics. Since this might make it of special interest to the Journal's readers, and since the subject is infrequently discussed in the literature of Medical Ethics, I decided to include it in this brief selection. CiteULike Connotea Del.icio.us What's this? (shrink)

This paper suggests that the practice of anamnesis—the taking of a patient history in preparation for making a diagnosis, as well as the related form of investigation, historia—offers a way to understand the role of medical collections in generating medical knowledge. Anamnesis derives from ancient Greek “recollecting” or “opening of memory,” and “taking a history” from historia, an ancient and early modern epistemic practice of gathering empirical observations from the past and present. Doctors and medical researchers perform, (...) this paper argues, a form of anamnesis when they access collections—of pathological organs, experimental animals, diagnostic slides, samples, and data—and the collections may in turn be seen as constituting institutional and disciplinary memories. It moreover shows that doctors and medical researchers in their work with collections negotiate two ways of organizing observations that are also present in an anamnesis. One way clusters and classifies observations, while the other traces developments and requires significant past observations to understand the present. This double nature plays out in different ways in different historical collections. Last, the paper itself may also be seen as performing an anamnesis: looking for patterns and tracing a development in medical history. It “opens the memory” of medical collection practices, and shows that medicine is past-heavy and that the past plays a central role in modern biomedicine. Anamnesis is thus used as a historiographical stance that seeks to understand present practices of generating knowledge about diseases through an inquiry into the past. (shrink)

Winner of the Los Angeles Times Book Prize With a new preface by the author In his most powerful and important book, renowned psychiatrist Robert Jay Lifton presents a brilliant analysis of the crucial role that German doctors played in the Nazi genocide. Now updated with a new preface, The Nazi Doctors remains the definitive work on the Nazi medical atrocities, a chilling exposé of the banality of evil at its epitome, and a sobering reminder of the darkest side (...) of human nature. (shrink)

Herbert, Dilinie The Ebola virus disease outbreak in West Africa is a tragedy of mass proportions. It has afflicted a region with poor public health infrastructure, communities fearful of medical intervention due to past atrocities, and in a situation where the people are protective of themselves and their families. As the death toll continues to rise, experimental treatments are being offered as a solution. The widespread use and management of these treatments is a challenge due to the social and (...) cultural structures that exists in these communities. An approach that is sensitive to these experiences needs to be observed. (shrink)

Much fundamental progress in medicine and, more broadly, in medical sciences has required or benefited from self-experiments. This review provides a definition of self-experiments in which experimenters themselves are subjects for their research, and it considers the logical steps which such experiments require. Lay, medical and scientific communities are often unaware of the contributions and the full range of outcomes from self-experiments. Hence, some implications for ethics committees are explored.

The aim of the present study was to compare and examine how medical students on term one and nine understand and adopt ideas and reasoning when estimating death-causes. Our hypothesis was that compared to students in the beginning of their medical curriculum, term nine students would be more inclined to adopt ideas about causality that allows physicians to alleviate an imminently dying patient, without being suspected for manslaughter—a practice referred to as proficiency creativity. We used a questionnaire containing (...) two similar cases describing an imminently dying patient who receive a drug in order to treat seizures. The treatment has the foreseen effect of shortening the patient’s life. In one version of the vignette the patient dies immediately and in the other one the patient dies 5 h after having received the drug. We asked medical students in their first term (n = 149) and ninth term (n = 106) to fill in the two randomly distributed questionnaires. We used a χ2 test to examine our hypothesis and choose as significance level 0.05. A majority of term-one students (53 %) stated that the patient died because of the provided drugs when dying immediately after and 32 % stated it when the patient died 5 h after providing the drug. The difference was significant (p = 0.007). A minority of term-nine students (20 vs. 16 %) stated the patient died because of the provided drug. The difference was not significant. The study indicates that term-nine students have espoused the idea that death-causes in such cases should always be classified as the underlying disease—even though another straightforward explanation could be the drug provided. To clinicians this might be a proficiency-creative strategy for managing a difficult legal dilemma. As hypothetical explanation we suggest that experienced clinicians might have transformed a normative issue of shortening life into an empirical issue about death-causes and tacitly transferred this strategy to term-nine students. If our hypothesis is supported by future studies, this kind of transferring proficiency creativity tacitly might impede changing the Penal Code even though it may be needed. (shrink)

Twelve contributors discuss critical issues affecting medical ethics. Topics include: the normative principles of medical ethics, concepts of health and disease, the physician-patient relationship, human experimentation, informed consent, genetics, ethical issues in organ transplantation, and moral.