The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central (...) to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void. (shrink)

Long awaited by the scholarly community, Wittgenstein's so-called _Big Typescript_ is presented here in an en face English–German scholar’s edition. Presents scholar’s edition of important material from 1933, Wittgenstein’s first efforts to set out his new thoughts after the publication of the _Tractatus Logico Philosophicus_ Includes indications to help the reader identify Wittgenstein’s numerous corrections, additions, deletions, alternative words and phrasings, suggestions for moves within the text, and marginal comments.

In the past 15 years a host of critical thinking books have appeared that teach students to find flaws in the arguments of others by learning to detect a number of informal fallacies. This book is not in that tradition. The authors of this book believe that while students learn to become vicious critics, they still continue to make the very mistakes they criticize in others. Thus, this book has adopted the approach of teaching the construction of good arguments first (...) and then introducing criticism as a secondary skill. Moreover, the emphasis of the book is not on learning to name fallacies, but on being able to identify weaknesses in an argument so as to be able to construct an effective critique of that argument. The book is accompanied by a workbook featuring a wealth of examples to help students acquire the material. (shrink)

This bilingual volume—English and German on facing pages—brings together the writings Wittgenstein composed during his stay in Dublin between October 1948 and March 1949, one of his most fruitful periods. He later drew more than half of his remarks for Part II of _Philosophical Investigations_ from this Dublin manuscript. A direct continuation of the writing that makes up the two volumes of _Remarks on the Philosophy of Psychology,_ this collection offers scholars a glimpse of Wittgenstein's preliminary thinking on one of (...) his most important works. G. H. von Wright and Heikki Nyman both teach at the University of Helsinki. (shrink)

Wittgenstein finished part 1 of the _Philosophical Investigations_ in the spring of 1945. From 1946 to 1949 he worked on the philosophy of psychology almost without interruption. The present two-volume work comprises many of his writings over this period. Some of the remarks contained here were culled for part 2 of the _Investigations_; others were set aside and appear in the collection known as Zettel. The great majority, however, although of excellent quality, have hitherto remained unpublished. This bilingual edition of (...) the _Remarks on the Philosophy of Psychology_ presents the first English translation of an essential body of Wittgenstein's work. It elaborates Wittgenstein's views on psychological concepts such as expectation, sensation, knowing how to follow a rule, and knowledge of the sensations of other persons. It also shows strong emphasis on the "anthropological" aspect of Wittgenstein's thought. Philosophers, as well as anthropologists, psychologists, and sociologists will welcome this important publication. (shrink)

Wittgenstein finished part 1 of the _Philosophical Investigations_ in the spring of 1945. From 1946 to 1949 he worked on the philosophy of psychology almost without interruption. The present two-volume work comprises many of his writings over this period. Some of the remarks contained here were culled for part 2 of the _Investigations_; others were set aside and appear in the collection known as Zettel. The great majority, however, although of excellent quality, have hitherto remained unpublished. This bilingual edition of (...) the _Remarks on the Philosophy of Psychology_ presents the first English translation of an essential body of Wittgenstein's work. It elaborates Wittgenstein's views on psychological concepts such as expectation, sensation, knowing how to follow a rule, and knowledge of the sensations of other persons. It also shows strong emphasis on the "anthropological" aspect of Wittgenstein's thought. Philosophers, as well as anthropologists, psychologists, and sociologists will welcome this important publication. (shrink)

Background: Biomedical research is influenced by many factors, including the involvement of stakeholder groups invested in research outcomes. Stakeholder involvement in research efforts raises questions of justice as stakeholders’ specific interests and motivations play a role in directing research resources that ultimately produce knowledge, shaping how different conditions (and affected individuals) are understood and treated by society. This issue is highly relevant to child psychiatry research where diagnostic criteria and treatment strategies are often controversial. Biological similarities and stakeholder differences between (...) attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) provide an opportunity to explore this issue by comparing research foci and stakeholder involvement in these conditions. Methods: A subset of ADHD and ASD research articles published between 1970 and 2010 were randomly selected from the PubMed database and coded for research focus, funding source(s), and author-reported conflicts of interest (COIs). Chi-squared analyses were performed to identify differences between and within ADHD and ASD research across time. Results: The proportion of ADHD research dedicated to basic, description, and treatment research was roughly similar and remained stable over time, while ASD research showed a significant increase in basic research over the past decade. Government was the primary research funder for both conditions, but for-profit funders were a notable presence in ADHD research, while joint funding efforts between nonprofit and government funders were a notable presence in ASD research. Lastly, COIs were noted more frequently in ADHD than in ASD research. Conclusions: Our study shows significant differences in research foci and funding sources between the conditions, and identifies the specific involvement of for-profit and nonprofit groups in ADHD and ASD, respectively. Our findings highlight the relationship between stakeholders outside the research community and research trajectories and suggest that examinations of these relationships must be included in broader considerations of biomedical research ethics. (shrink)

This bilingual volume—English and German on facing pages—brings together the writings Wittgenstein composed during his stay in Dublin between October 1948 and March 1949, one of his most fruitful periods. He later drew more than half of his remarks for Part II of Philosophical Investigations from this Dublin manuscript. A direct continuation of the writing that makes up the two volumes of Remarks on the Philosophy of Psychology, this collection offers scholars a glimpse of Wittgenstein's preliminary thinking on one of (...) his most important works. G. H. von Wright and Heikki Nyman both teach at the University of Helsinki. (shrink)

In his recent article "Remorse, Regret, and the Socratic Paradox" (Analysis 35.5 (1975) p.159-166) Professor C.‘ Grant Luckhardt attempted to show why those who deny that there is weakness of will need not be troubled by the phenomenon of remorse or regret. He did this by arguing (1) that contemporary formulations of the Socratic "To know the good is to do the good" principle are unacceptable and must be qualified and (2) that once the Socratic principle is properly qualified (...) remorse and regret will not constitute evidence against the truth of the Socratic principle. In my response I show (1) that Professor Luckhardt's proposed qualifications of the Socratic principle are unnecessary and that if we merely understand what the original principle asserts, then it is clear that the unqualified principle is not subject to the two sorts of difficulties that Luckhardt raises and (2) that even if the Socratic principle is modified in the proposed manner, it is still unable to answer the remorse/ regret objection. (shrink)

A previously unexplored method, combining logical and mathematical elements, is shown to yield substantial numerical improvements in the area of Diophantine approximations. Kreisel illustrated the method abstractly by noting that effective bounds on the number of elements are ensured if Herbrand terms from ineffective proofs of Σ 2 -finiteness theorems satisfy certain simple growth conditions. Here several efficient growth conditions for the same purpose are presented that are actually satisfied in practice, in particular, by the proofs of Roth's theorem due (...) to Roth himself and to Esnault and Viehweg. The analysis of the former yields an exponential bound of order exp(70ε -2 d 2 ) in place of exp(285ε -2 d 2 ) given by Davenport and Roth in 1955, where α is (real) algebraic of degree d ≥ 2 and $|\alpha - pq^{-1}| . (Thus the new bound is less than the fourth root of the old one.) The new bounds extracted from the other proof are polynomial of low degree (in ε -1 and log d). Corollaries: Apart from a new bound for the number of solutions of the corresponding Diophantine equations and inequalities (among them Thue's inequality), $\log \log q_\nu , where q ν are the denominators of the convergents to the continued fraction of α. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Big data and artificial intelligence (“AI”) promise to transform virtually all aspects of biomedical research and health care (Matheny et al. 2019), through facilitation of drug development, diagno...

A previously unexplored method, combining logical and mathematical elements, is shown to yield substantial numerical improvements in the area of Diophantine approximations. Kreisel illustrated the method abstractly by noting that effective bounds on the number of elements are ensured if Herbrand terms from ineffective proofs ofΣ2-finiteness theorems satisfy certain simple growth conditions. Here several efficient growth conditions for the same purpose are presented that are actually satisfied in practice, in particular, by the proofs of Roth's theorem due to Roth himself (...) and to Esnault and Viehweg. The analysis of the former yields an exponential bound of order exp in place of exp given by Davenport and Roth in 1955, whereαis algebraic of degreed≥ 2 and ∣α−pq−1∣ shrink)

The use of racial categories in biomedicine has had a long history in the United States. However, social hierarchy and discrimination, justified by purported scientific differences, has also plagued the history of racial categories. Because “race” has some correlation with biological and genetic characteristics, there has been a call not to “throw the baby out with the bathwater” by eliminating race as a research or clinical category. I argue that race is too undefined and fluid to be useful as a (...) proxy for biology or genetics. (shrink)

: A familiar criticism of bioethics charges it with being more conceptual than practical—having little application to the "real world." In order to answer its critics and keep its feet on the ground, bioethics must utilize the social sciences more effectively. Empirical research can provide the bridge between conceiving a moral vision of a better world, and actually enacting it.

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, “incidental” or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on (...) the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power aforded by new genomic analyses may lead to fndings of statistical, but not necessarily clinical, signifcance. This paper addresses the issues to be considered in deciding whether and how to disclose “incidental” fndings or other fndings of clinical signifcance that arise in the course of human genomic and genetic research. What research results should be ofered, and what should not be ofered? For which research should individual results be ofered to research participants, when should they be ofered, how, and to whom? (shrink)

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. However, no consensus exists as yet on the responsibilities of researchers to disclose individual research results to participants in human subjects research. “Genetic and genomic research” on humans varies widely, including association studies, examination of allele frequencies, and studies of natural selection, human migration, and genetic variation. For the purposes of this article, it is defined broadly (...) to include analysis of DNA collected from humans that has implications for human health. This paper addresses both research results of individual research participants that may be an intended product of the research, as well as unanticipated, “incidental” findings. (shrink)

A familiar criticism of bioethics charges it with being more conceptual than practical—having little application to the “real world.” In order to answer its critics and keep its feet on the ground, bioethics must utilize the social sciences more effectively. Empirical research can provide the bridge between conceiving a moral vision of a better world, and actually enacting it.

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

Physically frail, badly educated girls, brought up to lead useless lives as idle gentlewomen, married to dominant husbands, and relegated to "separate spheres" of life—these phrases have often been used to describe Victorian upper-middle-class women. M. Jeanne Peterson rejects such formulations and the received wisdom they embody in favor of a careful examination of Victorian ladies and their lives. Focusing on a network of urban professional families over three generations, this book examines the scope and quality of gentlewomen's education, their (...) physical lives, their relationship to money, their experience of family illness and death, and their relationships to men (brothers and friends as well as fathers and husbands). Peterson also examines the prominent place of work in the lives of these "leisured" Victorian ladies, both single and married. Far from idle, the mothers, wives, and daughters of Victorian clergymen, doctors, lawyers, university dons, and others were accomplished and productive members of society who made substantial public and private contributions to virtually every sphere of Victorian life. (shrink)

There are deep divides over the use of racial and ethnic categories in biomedical research and its application in both medical and non-medical contexts. On one side of a roughly described dividing line are practitioners who need to use every piece of information at their disposal to solve pressing, realworld problems in real time, such as making clinical diagnoses or identifying perpetrators of crime. On the other side are scientists and policy makers committed to meeting a scientific and social need (...) for accuracy and thus trying to avoid miscategorization.As Jay Cohn describes in this issue, medical practitioners in particular have used racial and ethnic categories to “enhance diagnostic and therapeutic precision.” He argues for retaining this practice. The plea, motivated by genuine concern for patients, is to avoid “throwing the baby out with the bathwater.” However, Cohn and others mischaracterize the nature of the debate. The argument is not about whether differences among populations exist, or even whether differences among “races” exist. (shrink)