Informed consent is the bedrock principle on which most of modern research ethics rest. That principle, like most others, has some exceptions, such as for emergency situations and for some studies involving very low risk. But what about situations that do not fall into either of these categories? Are there such research studies that are so important to society that we nonetheless are willing to involuntarily enroll subjects, without their informed consent?

Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading (...) cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)

Traditionally, organ retrieval from cadavers has taken place only in cases where the declaration of death has occurred using “brain death” criteria. Under these criteria, specific tests are performed to demonstrate directly a lack of brain activity. Recently, as a result of efforts to increase organ procurement, attention has been directed at the use of so-called “non-heart-beating” donors : individuals who are declared dead not as a result of direct measurements of brain function, but rather as a result of the (...) cessation of heart and respiratory functions. Attempts to obtain organs from such individuals have recently resulted in substantial negative publicity. Claims were made that the deaths of patients were being accelerated in order to get organs, and that sometimes organs were being removed from patients who were not yet dead. (shrink)

Traditionally, organ retrieval from cadavers has taken place only in cases where the declaration of death has occurred using “brain death” criteria. Under these criteria, specific tests are performed to demonstrate directly a lack of brain activity. Recently, as a result of efforts to increase organ procurement, attention has been directed at the use of so-called “non-heart-beating” donors : individuals who are declared dead not as a result of direct measurements of brain function, but rather as a result of the (...) cessation of heart and respiratory functions. Attempts to obtain organs from such individuals have recently resulted in substantial negative publicity. Claims were made that the deaths of patients were being accelerated in order to get organs, and that sometimes organs were being removed from patients who were not yet dead. (shrink)

More than 50 years ago, in a front-page article in the New York Times, the truth about what happened to hundreds of black men in a government-conducted research study was revealed to the American p...

Volume 20, Issue 7, July 2020, Page 80-82.

People of a certain age will immediately recognize the image of a distraught woman, hand to her forehead, bemoaning how she just now realized that she forgot to have children. Nielsen Busch and Mja...

Few would disagree with the notion that it would be a wonderful thing if we could more quickly learn how to treat, or better yet cure, diseases afflicting millions of people. Alex John London argue...

Much of what Ruth Faden and colleagues say squarely meshes with the ideas of the U.S. Department of Health and Human Services about reforming the system for protecting research subjects. Having said that, I want to turn to a very different part of the research universe, the elephant in the room, as it were: the world of interventional randomized clinical trials. Under the current regulatory system, these research subjects receive substantial protections. Most importantly, they are generally enrolled only after they (...) give their informed consent. The rationale for this approach is that research subjects are denied the core ethical protection provided to patients: there is no requirement that everything done to them be in their best interests. Faden and colleagues appear to be proposing to eliminate this informed consent requirement for a significant range of such trials. (shrink)

Volume 20, Issue 5, June 2020, Page 1-3.

Some transplant centers are making use of a four‐person organ exchange to encourage live donor kidney transplantation. Although no money changes hands, it is a quasi‐contractual arrangement and a step toward for‐profit transactions, and it threatens to undermine the organ donor system.

: Challenging the interpretation of Charles Fried's use of "equipoise" presented by Paul Miller and Charles Weijer in a recent issue of the Kennedy Institute of Ethics Journal , this commentary argues that Fried was in no way promoting the concept of equipoise. In fact, his key point was that patients have a right to know and to make their own decisions about participation in clinical trials, regardless of equipoise, however it is defined.

When seriously ill patients for whom existing treatments are inadequate are invited to participate in clinical trials that offer a new treatment, should those persons be considered “vulnerable”? And if so, what additional protections should they be accorded? This article attempts to provide some answers.

Suppose that someone has a serious illness. The illness will likely lead to significant disabilities, and may even cause death. Existing treatments are unsatisfactory. The patient learns about a clinical trial, in which some allegedly promising new treatment for that illness is being tested.Such seriously ill patients for whom existing treatments are unsatisfactory have sometimes been categorized as medically vulnerable in the literature. Should these patients indeed be considered vulnerable subjects and be provided with special protections? And if the answer (...) is yes, then what are those special protections? This article explores the possible answers to these questions.The federal regulations for the protection of research subjects have several provisions addressing the concept of vulnerability. The three subparts Subparts B, C, and D deal with specific categories of vulnerable subjects, but do relatively little to address broader issues relating to vulnerability that might apply to a category such as the medically vulnerable. The Common Rule is the only section containing general discussions of vulnerability. (shrink)

The factual premise: A clinical trial takes place, with results suggesting that a new treatment is better than standard care for a particular medical problem. One large group of physicians—call the...

Artificial intelligence (AI) has attracted an increasing amount of attention, both positive and negative. Its potential applications in healthcare are indeed manifold and revolutionary, and within the realm of medical imaging and radiology (which will be the focus of this paper), significant increases in accuracy and speed, as well as significant savings in cost, stand to be gained through the adoption of this technology. Because of its novelty, a norm of keeping humans “in the loop” wherever AI mechanisms are deployed (...) has become synonymous with good ethical practice in some circles. It has been argued that keeping humans “in the loop” is important for reasons of safety, accountability, and the maintenance of institutional trust. However, as the application of machine learning for the detection of lumbar spinal stenosis (LSS) in this paper’s case study reveals, there are some scenarios where an insistence on keeping humans in the loop (or in other words, the resistance to automation) seems unwarranted and could possibly lead us to miss out on very real and important opportunities in healthcare—particularly in low-resource settings. It is important to acknowledge these opportunity costs of resisting automation in such contexts, where better options may be unavailable. Using an AI model based on convolutional neural networks developed by a team of researchers at NUH/NUS medical school in Singapore for automated detection and classification of the lumbar spinal canal, lateral recess, and neural foraminal narrowing in an MRI scan of the spine to diagnose LSS, we will aim to demonstrate that where certain criteria hold (e.g., the AI is as accurate or better than human experts, risks are low in the event of an error, the gain in wellbeing is significant, and the task being automated is not essentially or importantly human), it is both morally permissible and even desirable to kick the humans out of the loop. (shrink)

The objective of this study was to determine whether consent forms in oncology clinical trials of commercially available treatments inform subjects that they may be able to obtain the treatments being investigated without participating in research. We acquired consent forms from a random sample of U.S. oncology clinical trials in the ClinicalTrials.gov database. We then examined a subgroup of the sample consisting of studies in which the treatments under investigations were commercially available. Less than 20% of the consent forms in (...) that group disclosed to subjects that they may be able to obtain the treatment being investigated without participating in the study . Our results suggest that potential research subjects are frequently not informed about important alternatives to research participation in studies involving commercially available treatments, which is a violation of both ethical and regulatory standards. (shrink)

The Ethics and Regulation of Research with Human Subjects, edited by Professors Carl Coleman of Seton Hall, Jerry Menikoff of the University of Kansas, Jesse Goldner of Saint Louis University, and Nancy Dubler of the Albert Einstein College of Medicine, is an up-to-date and authoritative collection of readings on ethical, legal, and policy issues in research with human subjects. The authors have modeled their text on the casebook style commonly used in law schools. At 746 pages, plus front (...) matter and an appendix, this book contains just about everything one needs to know for a thorough grasp on human subjects research, including federal and state regulations governing this research, interpretive guidance from federal agencies, international guidelines and codes, court decisions, historical documents and case studies, and selected readings from scholarly articles and books. The book includes written comments and questions to help students understand and interpret the readings. (shrink)

Counter to the popular impression that Adam Smith was a champion of selfishness and greed, Jerry Muller shows that the Inquiry into the Nature and Causes of the Wealth of Nations maintained that markets served to promote the well-being of ...

Coherence in conversations and in texts can be partially characterized by a set of coherence relations, motivated ultimately by the speaker's or writer's need to be understood. In this paper, formal definitions are given for several coherence relations, based on the operations of an inference system; that is, the relations between successive portions of a discourse are characterized in terms of the inferences that can be drawn from each. In analyzing a discourse, it is frequently the case that we would (...) recognize it as coherent, in that it would satisfy the formal definition of some coherence relation, if only we could assume certain noun phrases to be coreferential. In such cases, we will simply assume the identity of the entities referred to, in what might be called a “petty conversational implicature,” thereby solving the coherence and coreference problems simultaneously. Three examples of different kinds of reference problems are presented. In each, it is shown how the coherence of the discourse can be recognized, and how the reference problems are solved, almost as a by‐product, by means of these petty conversational implicatures. (shrink)

Preface 1 Introduction: The Persistence of the Attitudes 2 Individualism and Supervenience 3 Meaning Holism 4 Meaning and the World Order Epilogue Creation Myth Appendix Why There Still Has to be a Language of Thought Notes References Author Index.

At a time when the label "conservative" is indiscriminately applied to fundamentalists, populists, libertarians, fascists, and the advocates of one or another orthodoxy, this volume offers a nuanced and historically informed presentation of ...

Three negative affective dispositions—anger, anxiety, and depression—are hypothesized to increase physical disease risk and have been the subject of epidemiological studies. However, the overlap among the major negative affective dispositions, and the superordinate construct of trait negative affectivity are only beginning to be tested. Presented here is a narrative review of recent prospective studies that simultaneously tested anger, anxiety, depression, and trait NA as risk factors for cardiac outcomes. Anxiety and depression emerged as independent risk factors for premature heart disease (...) in population studies of persons nominally healthy at baseline, and for recurrence/mortality among patients with existing heart disease. General trait NA also was a cardiac risk factor in population samples. (shrink)

This volume is a collection of original contributions about the core knowledge in fundamental domains. It includes work on naive physics, such as formal specifications of intuitive theories of spatial relations, time causality, substance and physical objects, and on naive psychology.

We take it that Brandom’s sense of the geography is that our way of proceeding is more or less the first and his is more or less the second. But we think this way of describing the situation is both unclear and misleading, and we want to have this out right at the start. Our problem is that we don’t know what “you start with” means either in formulations like “you start with the content of words and proceed to the (...) content of sentences” or in formulations like “you start with the content of sentences and you proceed to the content of words.” Brandom’s official view seems to be that he’s talking about explanatory priorities (see the preceding quote); but we think that can’t really be what he has in mind, and we can’t find any alternative interpretation that seems plausible. Speaking just for ourselves, we’re inclined towards a relatively pragmatic view of explanation; what explanation we should “start with” depends, inter alia, on what it’s an explanation of and whom it’s an explanation for. But, in any case, we would have thought that explanatory priority is of more than heuristic interest only if it reflects a priority of some other kind: ontological, semantical, psychological, or whatever. In talking about what one “starts with”, Brandom must be claiming more than. (shrink)

The renowned philosopher Jerry Fodor, a leading figure in the study of the mind for more than twenty years, presents a strikingly original theory on the basic constituents of thought. He suggests that the heart of cognitive science is its theory of concepts, and that cognitive scientists have gone badly wrong in many areas because their assumptions about concepts have been mistaken. Fodor argues compellingly for an atomistic theory of concepts, deals out witty and pugnacious demolitions of rival theories, (...) and suggests that future work on human cognition should build upon new foundations. This lively, conversational, and superbly accessible book is the first volume in the Oxford Cognitive Science Series, where the best original work in this field will be presented to a broad readership. Concepts will fascinate anyone interested in contemporary work on mind and language. Cognitive science will never be the same again. (shrink)

This study synthesizes current information from the various fields of cognitive science in support of a new and exciting theory of mind. Most psychologists study horizontal processes like memory and information flow; Fodor postulates a vertical and modular psychological organization underlying biologically coherent behaviors. This view of mental architecture is consistent with the historical tradition of faculty psychology while integrating a computational approach to mental processes. One of the most notable aspects of Fodor's work is that it articulates features not (...) only of speculative cognitive architectures but also of current research in artificial intelligence. (shrink)

I agree with the commentators that study of physical disease risk conferred by affective dispositions such as anger/hostility, anxiety, and sadness, should be more cognizant of developments in emotion theory. Emotions differ in their functional value depending on the person’s lifespan trajectory. Discrete emotions have different psychophysiological signatures; and emotional competence, including production, regulation, and knowledge, may be critical in determining whether specific negative affects, or general negative affectivity, are toxic for physical health. Emotion researchers, however, have mainly focused on (...) acute affective experiences and ignored the general effects of negative affectivity, which subsumes the discrete negative affects. Most diseases develop over years so more needs to be known about the biological signatures of chronic specific affects and negative affectivity. (shrink)

Introduction: Something on the State of the Art 1 I. Functionalism and Realism 1. Operationalism and Ordinary Language 35 2. The Appeal to Tacit Knowledge in Psychological Explanations 63 3. What Psychological States are Not 79 4. Three Cheers for Propositional Attitudes 100 II. Reduction and Unity of Science 5. Special Sciences 127 6. Computation and Reduction 146 III. Intensionality and Mental Representation 7. Propositional Attitudes 177 8. Tom Swift and His Procedural Grandmother 204 9. Methodological Solipsism Considered as a (...) Research Strategy in Cognitive Psychology 225 IV. Nativism 10. The Present Status of the Innateness Controversy 257 Notes 317. (shrink)